Medical Device Quality System Regulation (QSR)
The Food and Drug Administration (FDA) regulates medical device quality based on a host of regulations, including the Quality System Regulation (QSR) outlined in 21 CFR Part 820 and Current Good Manufacturing Practices (CGMP). Medical device companies that maintain quality software systems are also covered by 21 CFR Part 11. Many medical device manufacturers, especially those that sell products overseas, also conform to ISO 13485 (Medical Devices Quality Management Systems), ISO 14971 (Medical Devices Applications of Risk Management), and ISO 9000 quality standards.
Medical Device Quality Challenges
A medical device company's ultimate goal is to produce a safe, reliable, and effective product. To achieve this goal, the company must address many challenges including:
- Inefficient Quality System: Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs, DHF, DMR, BOM and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections.
- Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
- High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a medical device company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
MasterControl Solutions for Medical Device Quality
Compliance is a state, not an event. A medical device company must not only attain quality compliance, but sustain it year after year. The MasterControl QSR software systems for medical device quality are an integrated quality management suite of configurable, easy-to-use solutions. The system can link disconnected processes like BOM, supplier, CAPA, customer complaints, change control, document management, and more. Our medical device quality management software helps companies attain and sustain compliance with FDA 21 CFR Part 820 and other requirements, like ISO 13485, by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution - and keeping it in a constant state of validation - is half the battle in sustaining compliance, MasterControl has actively developed new ways to reduce the time and effort involved in validating a new system and software upgrades.
Contact a MasterControl Representative for QSR Software Systems for Medical Device Quality
Contact a MasterControl representative for more information regarding quality control and quality assurance software for the bio device med industry.