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    [title] => FDA OKs Medtronic's SynchroMed II Pump with Remodulin to Treat Hypertension
    [short_title] => 
    [summary] => SynchroMed II drug delivery system and cardiac catheter technologies were leveraged to deliver Remodulin.
    [slug] => fda-oks-medtronics-synchromed-ii-pump-with-remodulin-to-treat-hypertension
    [body] => Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed II drug delivery system and cardiac catheter technologies were leveraged to deliver the PAH medication Remodulin (treprostinil) Injection developed by United Therapeutics Corporation. United Therapeutics will lead the commercial promotion of the ISR, with Medtronic support.
 
PAH is a severely debilitating and progressive disease that causes high blood pressure in the pulmonary arteries, ultimately resulting in right-heart failure and premature death. It predominantly affects women, who are typically diagnosed in their late 30s to early 50s.1,2,3
 
"External infusion pumps have been used to deliver prostacyclins for PAH, but managing the therapy places a significant burden on patients, interferes with their daily activities, and runs a high risk of infections," said David Steinhaus, M.D., general manager of the Heart Failure business, part of the Cardiac and Vascular Group at Medtronic. "This fully implantable drug delivery system was designed to address these serious patient care concerns."
 
The system is composed of the Company's SynchroMed II implantable drug infusion pump and a newly developed intravascular catheter to deliver Remodulin intravenously to patients who have previously been receiving Remodulin intravenously via an external infusion pump. Medtronic and United Therapeutics pursued parallel regulatory filings for the device and drug, respectively.
 
FDA approval was based on the DelIVery for PAH trial, a prospective, single-arm, non-randomized, open-label study conducted at 10 sites in the United States. It enrolled 64 patients (60 successfully implanted) and showed the implantable intravascular delivery system effectively delivered treprostinil, with a low rate of catheter-related complications, and a high rate of patient satisfaction.4
 
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
 
References
1 Thenappan T, Shah SJ, Rich S, Gomberg-Maitland M. A USA-based registry for pulmonary arterial hypertension: 1982-2006. Eur Respir J. 2007;30:1103-10
2 Humbert M. Update in pulmonary arterial hypertension. 2007. Am J Respir Crit Care Med. 2008;177:574-9
3 Runo JR, Loyd JE. Primary pulmonary hypertension. Lancet. 2003;361(9368):1533-44.
4 Bourge RC, Waxman AB, Gomberg-Maitland M, et al. Treprostinil administered to treat pulmonary arterial hypertension using a fully implantable programmable intravascular delivery system: Results of the Delivery for PAH trial. Chest. 2016;150(1):27-34. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-07-31 10:10:00 [updated_at] => 2018-07-31 10:17:48 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289576","288913","287984","287964","284494","284487","284246","283959","283697","283596","281299","280635","277744","274327","272544","282688","279015","270967","282390"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2018-07-31/fda-oks-medtronics-synchromed-ii-pump-with-remodulin-to-treat-hypertension/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 270967 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162443 [primary_image_old] => [slider_image_id] => 162443 [banner_image] => 0 [title] => AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System [short_title] => [summary] => EAP given for the treatment of Stage III pancreatic cancer. [slug] => angiodynamics-receives-fda-expedited-access-pathway-designation-for-the-nanoknife-system [body] => AngioDynamics Inc., a provider of minimally invasive medical devices for vascular access, peripheral vascular disease, surgery, and oncology, announced that the U.S. Food and Drug Administration (FDA) has granted the Expedited Access Pathway (EAP) designation to the company’s NanoKnife System and proposed indication for use for the treatment of Stage III pancreatic cancer.
 
The EAP program is designed to help patients gain more timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, for which no approved or cleared alternatives exist. This is achieved by expediting the device’s assessment and review processes through more interactive and timely communication with the FDA, pre- and post-market balance of data collection requirements, efficient and flexible clinical study design, FDA review team support and Agency senior management engagement, and priority review.
 
Pursuant to the recently enacted 21st Century Cures Act, the FDA has released draft guidance for a Breakthrough Devices Program, which, when finalized, will supersede the EAP. The FDA has indicated that all devices that receive EAP designation will gain Breakthrough Device designation when the guidance document becomes final.
 
Jim Clemmer, President and CEO of AngioDynamics, commented, “The Expedited Access Pathway and Breakthrough Devices Program is an important and meaningful initiative to prioritize review and approval for novel, innovative devices needed by patients for the treatment of life-threatening diseases and conditions. We are thrilled that the FDA has granted the EAP designation to NanoKnife for the treatment of Stage III pancreatic cancer and are excited to continue working with the FDA toward approval of NanoKnife as a treatment for the underserved patient population suffering from this deadly disease.”
 
According to the American Cancer Society, pancreatic cancer is the third leading cause of cancer related deaths in the United States and is projected to increase to the second leading cause within the next five years. There are over 55,000 new cases and 44,000 estimated deaths in the US annually.1 The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs. In fact, only 20 percent to 30 percent of patients are candidates for surgical resection at time of diagnosis.2 Approximately 40 percent percent of patients will present with Stage III and 40 percent with metastatic disease. Regardless of the stage of pancreatic cancer, it has the lowest survival rate of any cancer, with an overall one- and five-year survival rate of 27 percent and 8 percent, respectively.1
 
There are limited treatment options for Stage III and IV disease, with chemotherapy and/or radiotherapy considered the standard of care.2 There have been advancements in both techniques, but this has come at the cost of greater toxicity,3 limiting the patients that are candidates for the treatment.
 
The NanoKnife System has received 510(k) clearance from the FDA for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
 
The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.
 
AngioDynamics provides minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include ablation systems, fluid management systems, vascular access products, angiographic products and accessories drainage products, thrombolytic products and venous products. In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

References
1. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
2. J Natl Compr Canc Netw. 2017 Aug;15(8):1028-1061. doi: 10.6004/jnccn.2017.0131.
3. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
 
 
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-20 18:20:00 [updated_at] => 2018-02-20 18:56:28 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["261191","259387","255490","262272","261080","262288","264451","255147","267660","262289","264692","256939","264547","260336","255666","267985"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 272544 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 163413 [primary_image_old] => [slider_image_id] => 163413 [banner_image] => 0 [title] => FDA Expands Heart Valve Approval to Include Size for Newborn Patients [short_title] => [summary] => Now includes 15-mm valve size, making it the smallest mechanical heart valve approved in the world. [slug] => fda-expands-heart-valve-approval-to-include-size-for-newborn-patients [body] => The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
 
“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
 
Heart valve disease occurs if one or more of the four heart valves, which direct the flow of blood through the heart, fail to function properly. In pediatric patients, a malfunctioning heart valve is often the result of a congenital heart defect at birth. Each year, more than 35,000 babies in the U.S. are born with congenital heart defects, some of which will require heart valve surgery and, potentially, replacement heart valve surgery. However, prior to today’s approval, there have been limited replacement heart valve options available because of the patients’ small size. The Masters Series 15-mm HP valve represents an important treatment option for these patients.
 
The Master Series Mechanical Heart Valve is a rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position. The bileaflet design consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.
 
The Masters Series Mechanical Heart Valve was first approved in 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. Today’s approval expands the range of valve sizes available, providing smaller patients another treatment option.
 
The FDA evaluated clinical data from a single-arm study of 20 pediatric patients with serious heart failure ranging in age from 1.5 weeks to 27 months at the time of mitral valve implant. The data showed that one year after the implant procedure, the probability of survival was 69.3 percent and the probability of not experiencing a valve-related adverse event was 66.8 percent. Serious valve-related adverse events observed during the study through one-year follow-up included blood clots in the device and bleeding in the brain. Anticoagulation (blood thinning) therapy may be necessary after the procedure, to prevent clotting on the device, which can increase the risk of bleeding.
 
The Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.
 
The FDA granted approval of the Master Series Heart Valve to St. Jude Medical (now Abbott). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-06 14:21:00 [updated_at] => 2018-03-06 14:27:30 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["262744","271798","266993","266629","266433","261694","261493","260928","260092","258622","258073","272156","271932","271604","269320","269060","267660","266964","266470","264835","263664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 274327 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 164586 [primary_image_old] => [slider_image_id] => 164586 [banner_image] => 0 [title] => Monteris Medical NeuroBlate System Recalled Over Unexpected Laser Delivery Probe Heating [short_title] => [summary] => In some cases, the Laser Delivery Probes interacted with the MRI used to visualize catheter position, heating the probe. [slug] => monteris-medical-neuroblate-system-recalled-over-unexpected-laser-delivery-probe-heating [body] => The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
 
Recalled Product:
   
NeuroBlate Laser Delivery Probes are small, carbon dioxide (CO2)-cooled catheters that allow minimally invasive entry into a patient’s brain. The probes are part of the Monteris Medical NeuroBlate System, which is used during surgical procedures to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells in brain tissue.
 
In some cases, the NeuroBlate Laser Delivery Probes interact with the MRI system used to visualize the position of the catheter and cause unexpected heating and damage to the tip of the probe. This could cause unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain.
 
Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, the FDA recommends health care providers should strongly consider treating patients using alternative procedures if available. Health care providers who do not believe there is a viable alternative should use the device with extreme caution.
 
Patients who need to undergo brain tissue ablation and neurosurgeons who may be using these devices may be affected by this recall.
 
Monteris has issued three product advisories between October and December 2017 related to this issue; however the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating.
 
Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, health care providers should strongly consider treating patients using alternative procedures if available. The benefits and risks of the device, as well as the availability and benefits and risks of alternative treatment modalities, should be considered on an individual patient basis. Healthcare providers who do not believe there is a viable alternative should use the device with extreme caution.
 
For more information, read the Letter to Health Care Providers issued by the FDA on March 22, 2018. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-23 10:53:00 [updated_at] => 2018-03-23 11:01:14 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["272984","272970","272745","272628","272544","272156","271932","271604","269320","269060","274352","271646","270284","269417","265683","259565","270745","263840"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277744 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165734 [primary_image_old] => [slider_image_id] => 165734 [banner_image] => 0 [title] => FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices [short_title] => [summary] => Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness. [slug] => fdas-expansion-of-510k-program-seeks-to-end-predicate-testing-for-some-devices [body] => The U.S. Food and Drug Administration published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.
 
Such criteria could include FDA-recognized consensus standards and criteria established by the FDA guidances. In an FDA Voice blog, FDA Commissioner Scott Gottlieb, M.D. noted that the voluntary pathway will “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology” the FDA is being asked to evaluate.
 
"The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients. As part of these efforts, we’ve proposed a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said Dr. Gottlieb.
 
Substantial equivalence is rooted in a comparison between a new device and a predicate device, which is a legally marketed device to which a new device may be compared because it has the same intended use and similar enough technological characteristics. But predicate devices are sometimes decades old. The FDA believes performance criteria can facilitate this comparison.
 
Under this approach, if a predicate device meets certain levels of performance on characteristics relevant to its safety and effectiveness, and a new device meets or exceeds those same levels of performance on the same characteristics, the FDA could find the new device to be as safe and effective as the predicate. Instead of requiring direct comparison testing between the two devices, the FDA could support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device.
 
The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 10:08:00 [updated_at] => 2018-04-13 10:18:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["264451","277759","277496","263022","277521","277503","276758","275121","274327","272984","272970","272745","262289","266483","276264","264919","266487","270745","268909","262206","273584","269239"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279015 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Erin Wright, Validation Product Manager, MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166430 [primary_image_old] => [slider_image_id] => 166430 [banner_image] => 0 [title] => Software Validation: How It Should Be Done [short_title] => [summary] => With vague guidance from FDA, device makers need to ensure they are using best practices. [slug] => software-validation-how-it-should-be-done [body] => Software validation—the mere mention of it is enough to give a quality, IT, or validation professional a sinking feeling, if not a headache. Why? Because as most who have done it know, it can be one of the most resource-intensive, time-consuming, and costly compliance activities for regulated companies.
 
Under 21 CFR Part 11, organizations that operate under the auspices of the U.S. Food and Drug Administration (FDA) are required to validate electronic systems that create, modify, maintain, archive, retrieve, or transmit electronic records required by predicate regulations. Medical device firms must also comply with 21 CFR 820, a predicate rule that similarly requires software validation.
 
The perennial and problematic challenge comes from the fact that while the FDA requires validation, it does not specify how companies should go about the validation process. What the FDA wants is evidence that a company has documented how it intends to conduct validation and prove that it has done it the way it said it would. The objective of validation is to ensure the software will work as expected and specified. So, the question remains, “How do you conduct validation properly and successfully?”
 
In its guidance on “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” the FDA states, “We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.” In addition, the agency recommends that companies base their approach on a justified and documented risk assessment.
 
This doesn’t give much in the way of specific direction. As such, most companies are left erring on the side of caution when it comes to validation, and they validate much more than is necessary. The result is a validation process that takes months to accomplish. This often delays an organization’s ability to go live with new software or upgrade existing software. This causes the company to work with out-of-date software that can hinder its ability to optimize processes and stay up to date on the most recent security updates and other features.

Best Approach to Software Validation
In the Part 11 guidance, the FDA alludes that taking a risk-based approach cuts down the time it takes to conduct validation. Risk assessment is the key. Validation is a process that helps ensure life science companies are doing what they need to do to remove or mitigate risk. In fact, the argument can be made that most regulations are in place to remove risk along the product lifecycle, from the design and development through the use by consumers. A current trend among software suppliers, particularly those that create cloud-based software, is to provide their users with “canned” validation methodologies or scripts that are intended to cut time for the user. It is a step in the right direction, but it is not enough and can even put users at greater risk.
 
A simplified example in such a scenario would be a supplier providing a risk assessment for the software stating that “exporting a document is low risk.” Again, this is not enough and may introduce risk for the company because it all depends on how the software is actually used, not necessarily on how the supplier intended it to be used.
 
For instance, exporting documents may be low risk as a software feature, but if those documents are intended for regulatory submission, it suddenly increases the risk of the software to the company because of how it’s using the software. Another company may just export documents to a desktop for the purpose of sending those documents to employees via email. It’s the same software functionality, but a significantly different impact of failure for each company. This is why regulated companies can’t rely on supplier software risk assessments alone, since suppliers can’t take into account a company’s business practices.
 
It’s important to leverage the supplier validation documentation, but it can’t be the only step of the risk assessment. Risk must be assessed by functionality and usage, not just one or the other. A properly executed risk assessment will focus on the user’s critical business processes (CBPs), not just on the software.
 
Once risk assessments for individual CBPs have been determined, a validation approach for each area can be conducted. The following best-practice approach outlines three types of validations that can be utilized with a risk-based process. 
 
  1. High: Complete/comprehensive testing required. All usage scenarios must be thoroughly tested. This is similar to the “traditional” approach to validation.
  2. Medium: Testing of the functional requirements per the CBPs required with sufficient assurance that each item has been properly characterized.
  3. Low: No formal testing needed.
 
If a company understands its true risk of software adoption based on its CBPs, validation no longer needs to be an all-or-nothing activity. It can be done with surgical precision, cutting down the validation time from months to days or even hours. Companies can leverage their suppliers’ documentation, but they must properly assess their own software usage in relation to their regulatory requirements.
 

Erin Wright, MasterControl’s validation product manager, spearheads the efforts pertaining to the development of the company’s Validation Excellence Tool (VxT), which streamlines the risk-assessment process and greatly reduces validation time. She joined MasterControl in 2013 as a professional services consultant and worked closely with hundreds of regulated companies, including the FDA’s Center for Drug Evaluation and Research (CDER), Ancestry.com, Abbott Point of Care, Institute for Transfusion Medicine (ITxM), and the University of Utah, in conducting custom validation implementations. Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers. She graduated summa cum laude from West Chester University with a degree in psychology. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-26 09:11:00 [updated_at] => 2018-04-26 09:16:56 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["265305","265154","265280","276277","265289","278641","278237","278234","277967","277759","277744","277521","277503","277496","276758"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 270967 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 162443 [primary_image_old] => [slider_image_id] => 162443 [banner_image] => 0 [title] => AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System [short_title] => [summary] => EAP given for the treatment of Stage III pancreatic cancer. [slug] => angiodynamics-receives-fda-expedited-access-pathway-designation-for-the-nanoknife-system [body] => AngioDynamics Inc., a provider of minimally invasive medical devices for vascular access, peripheral vascular disease, surgery, and oncology, announced that the U.S. Food and Drug Administration (FDA) has granted the Expedited Access Pathway (EAP) designation to the company’s NanoKnife System and proposed indication for use for the treatment of Stage III pancreatic cancer.
 
The EAP program is designed to help patients gain more timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, for which no approved or cleared alternatives exist. This is achieved by expediting the device’s assessment and review processes through more interactive and timely communication with the FDA, pre- and post-market balance of data collection requirements, efficient and flexible clinical study design, FDA review team support and Agency senior management engagement, and priority review.
 
Pursuant to the recently enacted 21st Century Cures Act, the FDA has released draft guidance for a Breakthrough Devices Program, which, when finalized, will supersede the EAP. The FDA has indicated that all devices that receive EAP designation will gain Breakthrough Device designation when the guidance document becomes final.
 
Jim Clemmer, President and CEO of AngioDynamics, commented, “The Expedited Access Pathway and Breakthrough Devices Program is an important and meaningful initiative to prioritize review and approval for novel, innovative devices needed by patients for the treatment of life-threatening diseases and conditions. We are thrilled that the FDA has granted the EAP designation to NanoKnife for the treatment of Stage III pancreatic cancer and are excited to continue working with the FDA toward approval of NanoKnife as a treatment for the underserved patient population suffering from this deadly disease.”
 
According to the American Cancer Society, pancreatic cancer is the third leading cause of cancer related deaths in the United States and is projected to increase to the second leading cause within the next five years. There are over 55,000 new cases and 44,000 estimated deaths in the US annually.1 The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs. In fact, only 20 percent to 30 percent of patients are candidates for surgical resection at time of diagnosis.2 Approximately 40 percent percent of patients will present with Stage III and 40 percent with metastatic disease. Regardless of the stage of pancreatic cancer, it has the lowest survival rate of any cancer, with an overall one- and five-year survival rate of 27 percent and 8 percent, respectively.1
 
There are limited treatment options for Stage III and IV disease, with chemotherapy and/or radiotherapy considered the standard of care.2 There have been advancements in both techniques, but this has come at the cost of greater toxicity,3 limiting the patients that are candidates for the treatment.
 
The NanoKnife System has received 510(k) clearance from the FDA for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
 
The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.
 
AngioDynamics provides minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include ablation systems, fluid management systems, vascular access products, angiographic products and accessories drainage products, thrombolytic products and venous products. In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

References
1. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
2. J Natl Compr Canc Netw. 2017 Aug;15(8):1028-1061. doi: 10.6004/jnccn.2017.0131.
3. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
 
 
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-02-20 18:20:00 [updated_at] => 2018-02-20 18:56:28 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["261191","259387","255490","262272","261080","262288","264451","255147","267660","262289","264692","256939","264547","260336","255666","267985"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 272544 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 163413 [primary_image_old] => [slider_image_id] => 163413 [banner_image] => 0 [title] => FDA Expands Heart Valve Approval to Include Size for Newborn Patients [short_title] => [summary] => Now includes 15-mm valve size, making it the smallest mechanical heart valve approved in the world. [slug] => fda-expands-heart-valve-approval-to-include-size-for-newborn-patients [body] => The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
 
“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
 
Heart valve disease occurs if one or more of the four heart valves, which direct the flow of blood through the heart, fail to function properly. In pediatric patients, a malfunctioning heart valve is often the result of a congenital heart defect at birth. Each year, more than 35,000 babies in the U.S. are born with congenital heart defects, some of which will require heart valve surgery and, potentially, replacement heart valve surgery. However, prior to today’s approval, there have been limited replacement heart valve options available because of the patients’ small size. The Masters Series 15-mm HP valve represents an important treatment option for these patients.
 
The Master Series Mechanical Heart Valve is a rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position. The bileaflet design consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.
 
The Masters Series Mechanical Heart Valve was first approved in 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. Today’s approval expands the range of valve sizes available, providing smaller patients another treatment option.
 
The FDA evaluated clinical data from a single-arm study of 20 pediatric patients with serious heart failure ranging in age from 1.5 weeks to 27 months at the time of mitral valve implant. The data showed that one year after the implant procedure, the probability of survival was 69.3 percent and the probability of not experiencing a valve-related adverse event was 66.8 percent. Serious valve-related adverse events observed during the study through one-year follow-up included blood clots in the device and bleeding in the brain. Anticoagulation (blood thinning) therapy may be necessary after the procedure, to prevent clotting on the device, which can increase the risk of bleeding.
 
The Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.
 
The FDA granted approval of the Master Series Heart Valve to St. Jude Medical (now Abbott). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-06 14:21:00 [updated_at] => 2018-03-06 14:27:30 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["262744","271798","266993","266629","266433","261694","261493","260928","260092","258622","258073","272156","271932","271604","269320","269060","267660","266964","266470","264835","263664"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 274327 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 164586 [primary_image_old] => [slider_image_id] => 164586 [banner_image] => 0 [title] => Monteris Medical NeuroBlate System Recalled Over Unexpected Laser Delivery Probe Heating [short_title] => [summary] => In some cases, the Laser Delivery Probes interacted with the MRI used to visualize catheter position, heating the probe. [slug] => monteris-medical-neuroblate-system-recalled-over-unexpected-laser-delivery-probe-heating [body] => The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
 
Recalled Product:
   
NeuroBlate Laser Delivery Probes are small, carbon dioxide (CO2)-cooled catheters that allow minimally invasive entry into a patient’s brain. The probes are part of the Monteris Medical NeuroBlate System, which is used during surgical procedures to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells in brain tissue.
 
In some cases, the NeuroBlate Laser Delivery Probes interact with the MRI system used to visualize the position of the catheter and cause unexpected heating and damage to the tip of the probe. This could cause unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain.
 
Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, the FDA recommends health care providers should strongly consider treating patients using alternative procedures if available. Health care providers who do not believe there is a viable alternative should use the device with extreme caution.
 
Patients who need to undergo brain tissue ablation and neurosurgeons who may be using these devices may be affected by this recall.
 
Monteris has issued three product advisories between October and December 2017 related to this issue; however the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating.
 
Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, health care providers should strongly consider treating patients using alternative procedures if available. The benefits and risks of the device, as well as the availability and benefits and risks of alternative treatment modalities, should be considered on an individual patient basis. Healthcare providers who do not believe there is a viable alternative should use the device with extreme caution.
 
For more information, read the Letter to Health Care Providers issued by the FDA on March 22, 2018. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-03-23 10:53:00 [updated_at] => 2018-03-23 11:01:14 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["272984","272970","272745","272628","272544","272156","271932","271604","269320","269060","274352","271646","270284","269417","265683","259565","270745","263840"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 277744 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"U.S. Food and Drug Administration","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 165734 [primary_image_old] => [slider_image_id] => 165734 [banner_image] => 0 [title] => FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices [short_title] => [summary] => Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness. [slug] => fdas-expansion-of-510k-program-seeks-to-end-predicate-testing-for-some-devices [body] => The U.S. Food and Drug Administration published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.
 
Such criteria could include FDA-recognized consensus standards and criteria established by the FDA guidances. In an FDA Voice blog, FDA Commissioner Scott Gottlieb, M.D. noted that the voluntary pathway will “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology” the FDA is being asked to evaluate.
 
"The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients. As part of these efforts, we’ve proposed a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said Dr. Gottlieb.
 
Substantial equivalence is rooted in a comparison between a new device and a predicate device, which is a legally marketed device to which a new device may be compared because it has the same intended use and similar enough technological characteristics. But predicate devices are sometimes decades old. The FDA believes performance criteria can facilitate this comparison.
 
Under this approach, if a predicate device meets certain levels of performance on characteristics relevant to its safety and effectiveness, and a new device meets or exceeds those same levels of performance on the same characteristics, the FDA could find the new device to be as safe and effective as the predicate. Instead of requiring direct comparison testing between the two devices, the FDA could support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device.
 
The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-04-13 10:08:00 [updated_at] => 2018-04-13 10:18:23 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["264451","277759","277496","263022","277521","277503","276758","275121","274327","272984","272970","272745","262289","266483","276264","264919","266487","270745","268909","262206","273584","269239"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 279015 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Erin Wright, Validation Product Manager, MasterControl","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 166430 [primary_image_old] => [slider_image_id] => 166430 [banner_image] => 0 [title] => Software Validation: How It Should Be Done [short_title] => [summary] => With vague guidance from FDA, device makers need to ensure they are using best practices. [slug] => software-validation-how-it-should-be-done [body] => Software validation—the mere mention of it is enough to give a quality, IT, or validation professional a sinking feeling, if not a headache. Why? Because as most who have done it know, it can be one of the most resource-intensive, time-consuming, and costly compliance activities for regulated companies.
 
Under 21 CFR Part 11, organizations that operate under the auspices of the U.S. Food and Drug Administration (FDA) are required to validate electronic systems that create, modify, maintain, archive, retrieve, or transmit electronic records required by predicate regulations. Medical device firms must also comply with 21 CFR 820, a predicate rule that similarly requires software validation.
 
The perennial and problematic challenge comes from the fact that while the FDA requires validation, it does not specify how companies should go about the validation process. What the FDA wants is evidence that a company has documented how it intends to conduct validation and prove that it has done it the way it said it would. The objective of validation is to ensure the software will work as expected and specified. So, the question remains, “How do you conduct validation properly and successfully?”
 
In its guidance on “Part 11, Electronic Records; Electronic Signatures—Scope and Application,” the FDA states, “We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.” In addition, the agency recommends that companies base their approach on a justified and documented risk assessment.
 
This doesn’t give much in the way of specific direction. As such, most companies are left erring on the side of caution when it comes to validation, and they validate much more than is necessary. The result is a validation process that takes months to accomplish. This often delays an organization’s ability to go live with new software or upgrade existing software. This causes the company to work with out-of-date software that can hinder its ability to optimize processes and stay up to date on the most recent security updates and other features.

Best Approach to Software Validation
In the Part 11 guidance, the FDA alludes that taking a risk-based approach cuts down the time it takes to conduct validation. Risk assessment is the key. Validation is a process that helps ensure life science companies are doing what they need to do to remove or mitigate risk. In fact, the argument can be made that most regulations are in place to remove risk along the product lifecycle, from the design and development through the use by consumers. A current trend among software suppliers, particularly those that create cloud-based software, is to provide their users with “canned” validation methodologies or scripts that are intended to cut time for the user. It is a step in the right direction, but it is not enough and can even put users at greater risk.
 
A simplified example in such a scenario would be a supplier providing a risk assessment for the software stating that “exporting a document is low risk.” Again, this is not enough and may introduce risk for the company because it all depends on how the software is actually used, not necessarily on how the supplier intended it to be used.
 
For instance, exporting documents may be low risk as a software feature, but if those documents are intended for regulatory submission, it suddenly increases the risk of the software to the company because of how it’s using the software. Another company may just export documents to a desktop for the purpose of sending those documents to employees via email. It’s the same software functionality, but a significantly different impact of failure for each company. This is why regulated companies can’t rely on supplier software risk assessments alone, since suppliers can’t take into account a company’s business practices.
 
It’s important to leverage the supplier validation documentation, but it can’t be the only step of the risk assessment. Risk must be assessed by functionality and usage, not just one or the other. A properly executed risk assessment will focus on the user’s critical business processes (CBPs), not just on the software.
 
Once risk assessments for individual CBPs have been determined, a validation approach for each area can be conducted. The following best-practice approach outlines three types of validations that can be utilized with a risk-based process. 
 
  1. High: Complete/comprehensive testing required. All usage scenarios must be thoroughly tested. This is similar to the “traditional” approach to validation.
  2. Medium: Testing of the functional requirements per the CBPs required with sufficient assurance that each item has been properly characterized.
  3. Low: No formal testing needed.
 
If a company understands its true risk of software adoption based on its CBPs, validation no longer needs to be an all-or-nothing activity. It can be done with surgical precision, cutting down the validation time from months to days or even hours. Companies can leverage their suppliers’ documentation, but they must properly assess their own software usage in relation to their regulatory requirements.
 

Erin Wright, MasterControl’s validation product manager, spearheads the efforts pertaining to the development of the company’s Validation Excellence Tool (VxT), which streamlines the risk-assessment process and greatly reduces validation time. She joined MasterControl in 2013 as a professional services consultant and worked closely with hundreds of regulated companies, including the FDA’s Center for Drug Evaluation and Research (CDER), Ancestry.com, Abbott Point of Care, Institute for Transfusion Medicine (ITxM), and the University of Utah, in conducting custom validation implementations. Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers. She graduated summa cum laude from West Chester University with a degree in psychology. 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