Emily Ysaguirre, VERSE Solutions05.06.16
Medical device standards never die—in fact, they blossom. Standards are standards for a reason. This is typically because they have already been considered and accepted by authorities or chosen as general consensus for an approved model. A standard is a basic rule or principle that is used as a foundation of judgment.
Having said that, medical device standards are often reworked and enhanced to better solve the needs of those in this field. Often, changes made are with regard to risk and the management of such threats. Life sciences companies take on many challenges daily to create a greater good for people through quality, safety, and compliance. Biotechnology, blood services, medical device, and pharmaceutical companies all fall under this category. They are responsible for many prominent technologies, from cancer drugs to DNA research, and as a result, they must maintain a strong relationship with regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). ISO 13485 is the international standard relating to quality management systems for manufacturers of medical devices.
The best way to keep up with regulatory requirements is by largely incorporating them into every process. With the right enterprise software, companies are able to comply with regulations for good manufacturing practice (GMP), ISO, and FDA standards and initiatives to create unparalleled visibility and control over processes. Without automation, tasks and processes can get out of control. Putting standards in place allows for cleanliness and routine.
The ISO 13485:2015 standard has recently been updated to better serve the needs of suppliers, regulators, and customers. It’s more flexible in nature and focuses on the technicalities of risk. The older standard did place focus on risk management, but the new standard is focused on incorporating risk into every single aspect of procedures, including post-production recording.
This change in standard is more of a thinking standard to get all employees focused on the importance of identification and clarification in all steps. The goal is to be more prepared than ever before in an effort to prevent more adverse events than before.
With guidance on recording, traceability, and validation, the new standard takes compliance to the next level. It allows users to be in control of design and development, while monitoring employees and suppliers. It stimulates change in non-conformances to create and maintain sustainable improvement. Here’s how.
Complaint Handling
Including complaint handling in the new standard allows users to take action on adverse events quickly and efficiently. Complaint handling software manages the investigation and resolution of customer complaints, while ensuring compliance with FDA and GMP guidelines. It’s an organized method of making sure that complaints are recorded, reviewed, measured, and taken action upon in a timely manner. For companies in regulatory control, the ability to respond quickly is critical to their brand. Meeting the needs of customers and showing adherence to standards creates a stronger following and a more compliant organization. Fostering improvement and responsiveness to compliance is easy with complaint handling as it allows users to almost effortlessly transfer and escalate information from one process to the next. Complaint handling is responsible for collecting the right information, determining risk levels, and reporting on what actions had previously been taken. Complaint handling helps with nonconforming products and establishes a better connection with customers.
Audit Management
Conducting audits is critical to improvement. With audit management tools, users are able to set up profiles for each audit. This works to also save time by implementing integrated checklists and question-based data based on keywords from previous audit types. Audit management software creates a better approach in procedures and processes. It makes it easier to validate and verify with compliance clauses.
With audit management software, auditors must accept significant changes to sections before moving forward. The new standard believes that performing an investigation and finding background information on products will help to create a better and safer standard for business not only internally, but externally as well.
Risk Management
Risk management had been quite prevalent in the old standard, but in the new standard, it is expected that risk should be considered throughout every process. This means that risk must take a central approach within the cycle of production. Risk management takes on risk from all angles. It provides for risk assessment and analysis, and creates plans for risk reduction. This ensures that a product meets specifications from all angles. Monitoring and measuring equipment creates accurate results.
The new standard, ISO 13485:2015, also focuses more on root cause analysis. Root cause analysis is defined by the American Society for Quality as a factor that causes a non-conformance that should be permanently eliminated through process improvement. Root cause analysis uses a wide range of approaches through tools and techniques to uncover the cause of a problem. Systematic methods, such as the Five Whys Analysis, Cause Effect Analysis or the Fishbone Diagram, and the Fault Tree Analysis or Diagram, drill down to the real cause of a problem rather than simply treating the symptoms of a problem. This allows for all ends to be tied. This way, nothing is left floating around or left to chance. It is important to use root cause analysis to find answers, control, or mitigate situations and answer any questions.
The root causes analysis is essential to corrective and preventive action (CAPA) as it helps to prevent non-conformities by fixing challenges. Comprehensive CAPA action and effectiveness with risk mitigation history allows for a solution to be distributed in the best way possible. Good CAPA practices have the ability to run multiple types of workflows, each with its own unique processes, conduct investigations with root cause analysis, and then correct systemic events with verification that actions had been truly corrective to the process.
Part of the compliance goal is the ability to ensure that adverse events are properly escalated. CAPA obeys this standard. It is designed to act as a platform to foster correction with intuitive rules. The ability to inherit data from a previous adverse event, complaint, audit, non-conformity, etc., allows for the escalation of all outcomes.
Document Control
Document control links document records of any size or type to create workflows. These workflows route documents through review and approval phases, with a comprehensive change request workflow. This allows users to think more proactively about their choices. Creating traceability in processes allows for better control of records and enhances internal and regulatory compliance. Part of being compliant to the FDA’s GMP and ISO standards stems from good document control practices. Document control procedures, specifications, or work instructions through escalation, notifications, and other business rules ensure that tasks are completed on time and that you will have complete visibility into where documents are in the approval process.
Conclusion
The main goal of enhancing standards is to increase communication. Increasing communication within all parties aids in educated decision-making and prevents risks. Comprehensive quality is necessary for the design and manufacture of medical devices. Therefore, standards become the responsibility of all who are involved. Specific requirements work to reduce the chance of risk and increase product safety as well as organizational safety. It is important for all in the life sciences industry to adopt good manufacturing practices to work faster, safer, and better.
The promotion and awareness of regulatory requirements is the most effective method of achieving compliance within an organization. Medical device manufacturers have different specifications to follow, such as the verification and effectiveness of CAPAs, the ability to inspect and trace devices, and the filing of specific documents for the validation of sterile devices. For medical devices, the FDA sets controls to ensure product and consumer safety, and root cause analysis helps narrow down the search. CAPAs should not be formed for every single event that emerges. In fact, this could take away from solving events in a timely manner. CAPAs should be saved for only the most deserving of events, so it is important to have enterprise management software to help uncover which events that may be.
As time goes on, and the market rises to meet high demand, standards for design, manufacturing, exportation, and sales of medical devices must match. We need control over devices that are being made as well as background information on how the product is being manufactured and sold. Standards like ISO help keep a number on products sold and their quality. Standards are important because they fight for consistency and promote change on how to establish proficiency.
Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps to automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com.
Having said that, medical device standards are often reworked and enhanced to better solve the needs of those in this field. Often, changes made are with regard to risk and the management of such threats. Life sciences companies take on many challenges daily to create a greater good for people through quality, safety, and compliance. Biotechnology, blood services, medical device, and pharmaceutical companies all fall under this category. They are responsible for many prominent technologies, from cancer drugs to DNA research, and as a result, they must maintain a strong relationship with regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). ISO 13485 is the international standard relating to quality management systems for manufacturers of medical devices.
The best way to keep up with regulatory requirements is by largely incorporating them into every process. With the right enterprise software, companies are able to comply with regulations for good manufacturing practice (GMP), ISO, and FDA standards and initiatives to create unparalleled visibility and control over processes. Without automation, tasks and processes can get out of control. Putting standards in place allows for cleanliness and routine.
The ISO 13485:2015 standard has recently been updated to better serve the needs of suppliers, regulators, and customers. It’s more flexible in nature and focuses on the technicalities of risk. The older standard did place focus on risk management, but the new standard is focused on incorporating risk into every single aspect of procedures, including post-production recording.
This change in standard is more of a thinking standard to get all employees focused on the importance of identification and clarification in all steps. The goal is to be more prepared than ever before in an effort to prevent more adverse events than before.
With guidance on recording, traceability, and validation, the new standard takes compliance to the next level. It allows users to be in control of design and development, while monitoring employees and suppliers. It stimulates change in non-conformances to create and maintain sustainable improvement. Here’s how.
Complaint Handling
Including complaint handling in the new standard allows users to take action on adverse events quickly and efficiently. Complaint handling software manages the investigation and resolution of customer complaints, while ensuring compliance with FDA and GMP guidelines. It’s an organized method of making sure that complaints are recorded, reviewed, measured, and taken action upon in a timely manner. For companies in regulatory control, the ability to respond quickly is critical to their brand. Meeting the needs of customers and showing adherence to standards creates a stronger following and a more compliant organization. Fostering improvement and responsiveness to compliance is easy with complaint handling as it allows users to almost effortlessly transfer and escalate information from one process to the next. Complaint handling is responsible for collecting the right information, determining risk levels, and reporting on what actions had previously been taken. Complaint handling helps with nonconforming products and establishes a better connection with customers.
Audit Management
Conducting audits is critical to improvement. With audit management tools, users are able to set up profiles for each audit. This works to also save time by implementing integrated checklists and question-based data based on keywords from previous audit types. Audit management software creates a better approach in procedures and processes. It makes it easier to validate and verify with compliance clauses.
With audit management software, auditors must accept significant changes to sections before moving forward. The new standard believes that performing an investigation and finding background information on products will help to create a better and safer standard for business not only internally, but externally as well.
Risk Management
Risk management had been quite prevalent in the old standard, but in the new standard, it is expected that risk should be considered throughout every process. This means that risk must take a central approach within the cycle of production. Risk management takes on risk from all angles. It provides for risk assessment and analysis, and creates plans for risk reduction. This ensures that a product meets specifications from all angles. Monitoring and measuring equipment creates accurate results.
The new standard, ISO 13485:2015, also focuses more on root cause analysis. Root cause analysis is defined by the American Society for Quality as a factor that causes a non-conformance that should be permanently eliminated through process improvement. Root cause analysis uses a wide range of approaches through tools and techniques to uncover the cause of a problem. Systematic methods, such as the Five Whys Analysis, Cause Effect Analysis or the Fishbone Diagram, and the Fault Tree Analysis or Diagram, drill down to the real cause of a problem rather than simply treating the symptoms of a problem. This allows for all ends to be tied. This way, nothing is left floating around or left to chance. It is important to use root cause analysis to find answers, control, or mitigate situations and answer any questions.
The root causes analysis is essential to corrective and preventive action (CAPA) as it helps to prevent non-conformities by fixing challenges. Comprehensive CAPA action and effectiveness with risk mitigation history allows for a solution to be distributed in the best way possible. Good CAPA practices have the ability to run multiple types of workflows, each with its own unique processes, conduct investigations with root cause analysis, and then correct systemic events with verification that actions had been truly corrective to the process.
Part of the compliance goal is the ability to ensure that adverse events are properly escalated. CAPA obeys this standard. It is designed to act as a platform to foster correction with intuitive rules. The ability to inherit data from a previous adverse event, complaint, audit, non-conformity, etc., allows for the escalation of all outcomes.
Document Control
Document control links document records of any size or type to create workflows. These workflows route documents through review and approval phases, with a comprehensive change request workflow. This allows users to think more proactively about their choices. Creating traceability in processes allows for better control of records and enhances internal and regulatory compliance. Part of being compliant to the FDA’s GMP and ISO standards stems from good document control practices. Document control procedures, specifications, or work instructions through escalation, notifications, and other business rules ensure that tasks are completed on time and that you will have complete visibility into where documents are in the approval process.
Conclusion
The main goal of enhancing standards is to increase communication. Increasing communication within all parties aids in educated decision-making and prevents risks. Comprehensive quality is necessary for the design and manufacture of medical devices. Therefore, standards become the responsibility of all who are involved. Specific requirements work to reduce the chance of risk and increase product safety as well as organizational safety. It is important for all in the life sciences industry to adopt good manufacturing practices to work faster, safer, and better.
The promotion and awareness of regulatory requirements is the most effective method of achieving compliance within an organization. Medical device manufacturers have different specifications to follow, such as the verification and effectiveness of CAPAs, the ability to inspect and trace devices, and the filing of specific documents for the validation of sterile devices. For medical devices, the FDA sets controls to ensure product and consumer safety, and root cause analysis helps narrow down the search. CAPAs should not be formed for every single event that emerges. In fact, this could take away from solving events in a timely manner. CAPAs should be saved for only the most deserving of events, so it is important to have enterprise management software to help uncover which events that may be.
As time goes on, and the market rises to meet high demand, standards for design, manufacturing, exportation, and sales of medical devices must match. We need control over devices that are being made as well as background information on how the product is being manufactured and sold. Standards like ISO help keep a number on products sold and their quality. Standards are important because they fight for consistency and promote change on how to establish proficiency.
Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps to automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com.