GxP Regulatory Requirements for Medical Device Companies
The Food and Drug Administration (FDA) regulates GxP processes in the medical device industry based on a plethora of regulations, including the Quality System Regulation (QSR) outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP). Companies that utilize electronic record-keeping systems must also maintain compliance with 21 CFR Part 11, which is predicated on FDA GxP requirements. Many medical device manufacturers, especially those that sell products overseas, must conform to ISO 13485(Medical Devices Quality Management System Requirements for Regulatory Purposes), ISO 14971 (Medical Devices - Application of Risk Management to Medical Devices), and ISO 9000 standards. Public companies or those companies that are planning to go public or are acquired by public companies are subject to Sarbanes-Oxley Act (SOX) requirements as well. These are just a few of the GxP regulations that medical device developers must contend with as a product moves from development to commercialization.
Medical Device Product Development Challenges
A medical device company's ultimate goal is to produce a safe, reliable, and effective product in a timely manner while staying ahead of the competition and staying in compliance with GxP requirements. To achieve this goal, the company must address many challenges, including:
- Inefficient, Paper-based Document Management Systems that Delay Time to Market: Companies with multiple facilities and employees in different locations may initially find it less expensive to maintain separate GxP systems. Typically, to keep costs down, these systems are paper-based or hybrid paper/electronic in their early phases. In the long term, however, these inefficient systems will require employees to devote an enormous amount of time to tasks that could be streamlined by an automated system, such as: routing SOPs, DHF, DMR, 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 Quality Management Processes: GxP processes that are not connected to each other cause delays and adversely affect the device being developed. For example, a change control process that is not connected to customer complaint, CAPA, training, and other processes is likely to cause delays in change implementation. A CAPA process that is not connected to the rest of the system may produce an unreliable root cause investigation due to inadequate information availability.
- High Cost of Validation: 21 CFR Part 11 requires computer system validation as a means of protecting the integrity of electronic records and signatures. Even if a medical device company successfully automates its paper-based systems, it still faces the daunting work and high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance costs.
MasterControl GxP Process Management Software Solutions
Compliance is a state, not an event. A medical device company must not only attain compliance, but sustain it year after year. The MasterControl™ integrated process management and document management suite is a configurable, easy-to-use solution that helps companies attain and maintain compliance with FDA, ISO and other regulations by automating and managing GxP processes in an efficient and cost-effective manner. This connectivity helps improve communication between departments, promotes quality and compliance throughout the enterprise by allowing managers to continuously monitor and proactively improve all GxP processes throughout the entire product development lifecycle. Some of these key processes include:
- Labeling and Promotion
- Corporate and Supplier Compliance
- Production / Manufacturing Support
MasterControl makes it possible for medical device developers to meet key GxP requirements and ISO standards while also increasing efficiency and keeping compliance costs down. MasterControl helps companies to recognize GxP compliance as a part of the corporate culture by enabling compliance to be enforced across the enterprise in every department. By connecting company personnel with relevant data and processes, everyone is able to see the big picture. The result is an environment that fosters collaboration and allows managers to visualize and monitor all product development processes as a unified system.
Recognizing that validating a software solution and keeping the software in a continuous state of validation is half the battle in maintaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system based on the risk of each individual company.
Contact For More Details About Medical Device Process Management and Document Management Software Solutions
In order to get more comprehensive information regarding medical device process management and document management software solutions, feel free to contact MasterControl representative.