“Learn about the significance of the Quality System Record (QSR) in ensuring FDA compliance for medical device manufacturers. Explore QSR’s role in quality control, production integrity, and FDA inspections.”
It is a guardrail for quality control, production integrity and good manufacturing practices (GMP) in the industry: the Quality System Record (QSR).
In the ever-evolving area of life science industry, medical device manufacturers option numerous challenges in addition to responsibilities where concern over patient safety and product efficacy takes top priority. The foundation of these manufacturers’ compliance is the FDA’s Quality System Regulation (QSR), which is part 820.
The QSR: at the Core of Compliance
Introduction:
Quality System Regulation (QSR) is a broad regulatory standard that applies to every medical device manufacturer, irrespective of their size or the type of medical devices being manufactured.
It is an essential step to receive FDA approval before marketing a medical device in the United States. The QSR includes all manufacturing processes, procedures and documentation, which are maintained in the Quality System Record (QSR).
Divining Subpart M – Records: One of the Most Crucial Parts Of QSR
Subpart M is a separate section in the Quality System Regulation (QSR) that includes requirements for documentation of medical device manufacturing and quality control operations. This is where the Quality System Record finds its importance.
Understanding Quality System Record (QSR)
The QSR is a collection of records that are not device-type specific. It is a central repository for all activities and processes defined by the regulatory requirements of Part 820. Simply put, it is a microcosm of the nature of regulatory compliance within the medical device landscape.
Highlights from the Quality System Record (QSR)
The QSR requires medical device manufacturers to include certain procedures and documentation addressing activities specified in Part 820. These records help to guarantee compliance with FDA requirements and standards.
Design Info QSR: Designing & getting approval
Quality System Regulation [QSR] is written in 21 CFR, Sec.820.40 Preparation and Approval QSR, designates the outline of preparation with care and approvals. This is an essential step in ensuring that the record is complete, accurate and aligns with the FDA requirements of stringent quality management practices.
Part 1: The Accessibility Mandate – A Cornerstone of Regulation
One of the most important requirement is that access to records must be provided for review and assessment by FDA inspectors during inspections. This access provides the FDA means to determine a manufacturer adherence of QSR within short order and without uncertainty.
Keeping Records for Inspection: Easing the Road to Compliance
Medical device manufacturers are also required to retain the QSR for a certain timeframe to allow for FDA inspections. Easy and timely access to records during inspections not only makes the evaluation faster but also minimizes interruptions in your manufacturing operations.
The QSR, or Quality System Record, is a critical part of the Medical Device Quality System Regulation. Here is why it is paramount:
Show Compliance: The QSR presents a detailed plan of quality management practices that the manufacturer must follow, which allows the FDA inspector easily assess compliance with FDA regulations in medical devices leading to safety and effectiveness.
Clarity on Quality & Transparency: With comprehensive documentation, the QSR enables traceability and accountability across manufacturing process so that the origin of problems can be identified quickly, and corrective actions can be taken in a timely manner.
Improved Quality Control: The QSR is a forcible continuous improvement mechanism for medical device manufacturers as it helps keep track of processes and quality control improvements over time, which in turn reinforces consistency about quality.
Preparing for FDA Inspections: The QSR gives FDA inspectors a bird-eye view of an overall pipeline and plant or manufacturer. This availability of these records makes the inspection process easier and less disruptive.
Compliance with Quality System Regulation (QSR)
In order to meet the Medical Device Quality System Regulation mandated by the FDA, medical device manufacturers can do this in some key stages.
Detailed Documentation: The manufacturer is required to lay out detailed procedures, which need not be followed, together with documentation of all possible activities related to design and development, manufacturing, and post-market surveillance.
Training and Awareness: Employee training and awareness are critical for compliance. Employees who are well-informed contribute to a climate of quality and safety in the organization.
Document Control: Stringent document control enforces the authenticity, integrity and availability of records. That encompasses version control, approvals and repository.
Quality System Record: The manufacturer shall maintain the Quality System Record for at least two years after the completion of a device transfer (Note that other records may require longer retention).
Continuous Improvement: periodic internal audits and management review, to identify areas for improvement, and confirm that QSR requirements continue to be met.
When problems do occur, corrective and preventative actions must be implemented quickly.
To put it briefly, the Medical Device Quality System Regulation by FDA is an outline and its aim is to guarantee safety and efficacy of medical devices.
At the heart of this framework is the need to keep an elaborate Quality System Record (QSR). The QSR is not only an important part to be able to verify compliance but also strengthens the quality control measures and facilitates easy inspections by the FDA as well.
Get in touch with BioBoston Consulting today or check out our website to know more on how we can help your organization.
