Rachel Beavins Tracy, EtQ09.01.17
Homegrown systems and paper-based processes can create unnecessary risk for medical device companies when it comes to document management. From policies to manuals, regulatory reports to standard operating procedures (SOPs), these companies deal with a staggering number of documents on a daily basis.
And while organizations are increasingly digitizing their document control processes, many companies still have a long way to go. Document control is central to certification and regulatory requirements that include multiple ISO standards, U.S. Food and Drug Administration (FDA) regulations, and Good Manufacturing Practices (GMP).
And yet, according to a McKinsey & Company report, employees spend almost 20 percent of their time searching for and gathering internal information. That means out of every five workers, only four are actually getting work done at any given moment. The problem points to how common document control problems are in many organizations.
This article will examine six document control problems common in life sciences, and how to address these gaps.
1. Out-of-Control Versioning
For anyone who’s had a computer crash and lost precious information, the mantra is “save early and often.” But what happens when documents need to be updated? Many companies struggle with a large number of outdated “rogue” copies waiting to trip up the unsuspecting user.
When it comes to storing important documents, more isn’t better. The proliferation of documents lead to costly versioning issues such as:
2. Unmanaged SOP Changes
Producing, validating, and officiating changes in SOPs takes time, and is a process involving multiple people and groups. But when companies rely on manual or paper-based processes, SOP changes are often communicated verbally or written on scraps of paper left for the next user.
Document Control tools can help minimize this type of problem, allowing organizations to:
Producing a final report when multiple groups contribute to a project can be difficult to manage, especially when individuals make substantive edits. It’s common to have a working document that everyone contributes to, but this can backfire when everyone makes revisions in different versions of the original document.
What starts out as one draft can easily mushroom into a dozen copies, increasing the likelihood that errors or incomplete information ends up in the final version. Obviously, this is not where anyone wants to be when dealing with the FDA.
Routing and review functions within document control software helps avoid these problems, allowing setup of sequential routing customized to your workflow.
These tools automatically remind users and keep managers up-to-date on the revision progress.
4. Outdated Emergency Procedures
One document needing to stay current is the emergency plan used in the laboratory. Often, these are full of well-intentioned lists of outdated emergency contacts, directions, and references to equipment that may or may not be in the lab anymore. Even worse, highly hazardous materials may be in the lab that emergency manuals do not account for. Your plans are only as good as the information in them, as well as the accessibility of the plans.
Document control software helps to better manage updates to emergency procedures, including:
It’s not uncommon for audits to come back with document control findings. Some may be minor, while others can take serious reworking to untangle (particularly if companies rely on paper-based systems or network drives).
Common issues involve:
Studies show the average person spends an entire day of every week at work just looking for information. Nowhere is this truer than in medical device companies, where many manufacturers struggle under a huge documentation burden throughout the regulatory process.
In industries where every delay means much less time for new products to deliver value for the company, inefficient and outdated document management is simply unacceptable. Research shows document control tools deliver annual savings of over $800,000 in productivity costs alone, to say nothing of the competitive advantage gained by that productivity.
These examples show that firms can’t just “wing it” when it comes to document management. Life science market leaders recognize this fact, implementing robust document control processes to effectively manage the flow of information.
Closing Thoughts
The Document Control System sets the foundation for an effective quality system, allowing organizations to centralize documents from policies and procedures to work instructions, and so on. Doing this manually can be an error-prone, time-consuming process.
An automated process will provide a total solution for document control—from the creation of documents to managing change, to approval and training on all documents.
Perhaps more than any other element, it’s very easy to lose control of essential documents. The biggest issue is multiple or even conflicting versions, all spread out across different network drives and e-mail chains.
Automated document control tools keep the most essential documents in order. The tools allow access to key documents from a centralized repository, automate routing for revision and approval, limit access to individuals with the right permissions, and eliminate versioning issues, lost items, and delays.
Rachel Beavins Tracy is a writer for ETQ with expertise in healthcare and technology topics. She has a master’s degree from Vanderbilt University and has been writing for businesses since 2008.
And while organizations are increasingly digitizing their document control processes, many companies still have a long way to go. Document control is central to certification and regulatory requirements that include multiple ISO standards, U.S. Food and Drug Administration (FDA) regulations, and Good Manufacturing Practices (GMP).
And yet, according to a McKinsey & Company report, employees spend almost 20 percent of their time searching for and gathering internal information. That means out of every five workers, only four are actually getting work done at any given moment. The problem points to how common document control problems are in many organizations.
This article will examine six document control problems common in life sciences, and how to address these gaps.
1. Out-of-Control Versioning
For anyone who’s had a computer crash and lost precious information, the mantra is “save early and often.” But what happens when documents need to be updated? Many companies struggle with a large number of outdated “rogue” copies waiting to trip up the unsuspecting user.
When it comes to storing important documents, more isn’t better. The proliferation of documents lead to costly versioning issues such as:
- Ordering the wrong amount, type, or size of supplies and components based on an outdated specification.
- Disruption in production schedule and delayed time to market.
- Unplanned downtime and lower operational efficiency.
2. Unmanaged SOP Changes
Producing, validating, and officiating changes in SOPs takes time, and is a process involving multiple people and groups. But when companies rely on manual or paper-based processes, SOP changes are often communicated verbally or written on scraps of paper left for the next user.
Document Control tools can help minimize this type of problem, allowing organizations to:
- Notify people when SOP changes alter testing parameters.
- Generate reports to show who has completed the required training on updated SOPs (and who hasn’t).
- Link Supplier Management and Document Control applications to ensure changes in raw material specs trigger appropriate SOP updates.
Producing a final report when multiple groups contribute to a project can be difficult to manage, especially when individuals make substantive edits. It’s common to have a working document that everyone contributes to, but this can backfire when everyone makes revisions in different versions of the original document.
What starts out as one draft can easily mushroom into a dozen copies, increasing the likelihood that errors or incomplete information ends up in the final version. Obviously, this is not where anyone wants to be when dealing with the FDA.
Routing and review functions within document control software helps avoid these problems, allowing setup of sequential routing customized to your workflow.
These tools automatically remind users and keep managers up-to-date on the revision progress.
4. Outdated Emergency Procedures
One document needing to stay current is the emergency plan used in the laboratory. Often, these are full of well-intentioned lists of outdated emergency contacts, directions, and references to equipment that may or may not be in the lab anymore. Even worse, highly hazardous materials may be in the lab that emergency manuals do not account for. Your plans are only as good as the information in them, as well as the accessibility of the plans.
Document control software helps to better manage updates to emergency procedures, including:
- Linking change management initiatives to emergency procedure updates to account for changes in processes, people, or equipment.
- Triggering new employee training requirements as necessary, which can save tens of thousands of dollars (or more) in regulatory fines for failure to train workers on chemical hazards.
- Keeping supervisors updated on the status of emergency plans.
It’s not uncommon for audits to come back with document control findings. Some may be minor, while others can take serious reworking to untangle (particularly if companies rely on paper-based systems or network drives).
Common issues involve:
- Not including employees who use the documents in writing or review. This often means people just follow their own protocol or use an older one that served them better.
- Inadequate change management processes that can’t keep up with rapid changes in manufacturing, and/or where multiple facilities are involved.
- Not being able to find documents at the point of use. It’s not unheard of for companies to call suppliers before an audit to ask for copies of their own drawings because they couldn’t find them.
Studies show the average person spends an entire day of every week at work just looking for information. Nowhere is this truer than in medical device companies, where many manufacturers struggle under a huge documentation burden throughout the regulatory process.
In industries where every delay means much less time for new products to deliver value for the company, inefficient and outdated document management is simply unacceptable. Research shows document control tools deliver annual savings of over $800,000 in productivity costs alone, to say nothing of the competitive advantage gained by that productivity.
These examples show that firms can’t just “wing it” when it comes to document management. Life science market leaders recognize this fact, implementing robust document control processes to effectively manage the flow of information.
Closing Thoughts
The Document Control System sets the foundation for an effective quality system, allowing organizations to centralize documents from policies and procedures to work instructions, and so on. Doing this manually can be an error-prone, time-consuming process.
An automated process will provide a total solution for document control—from the creation of documents to managing change, to approval and training on all documents.
Perhaps more than any other element, it’s very easy to lose control of essential documents. The biggest issue is multiple or even conflicting versions, all spread out across different network drives and e-mail chains.
Automated document control tools keep the most essential documents in order. The tools allow access to key documents from a centralized repository, automate routing for revision and approval, limit access to individuals with the right permissions, and eliminate versioning issues, lost items, and delays.
Rachel Beavins Tracy is a writer for ETQ with expertise in healthcare and technology topics. She has a master’s degree from Vanderbilt University and has been writing for businesses since 2008.
