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Teams can reduce inspection time by using standardized and streamlined methods and having rapid access to data and documentation reporting.
Reporting regulations in the Medical Devices and Biopharmaceutical industries are continually changing and reforming. The Physician Payments Sunshine Act's expanded reporting requirements are a recent example of this. Manufacturers of medical devices and biopharmaceuticals will be required to report any payments or transfers of value made to physicians or teaching hospitals under these rules. This will go into effect in January 2022, which means that medical device and biopharmaceutical companies must begin tracking payments and other value transfers in January 2021 to be ready to report in March 2022.
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Best Practices for Quality and Compliance Management
Regulatory documentation is reviewed regularly. As a result, it is critical to make sure the submissions are compliant with current regulatory requirements. Using a digital document and quality management system can assist in maintaining data control. So here are five pointers to help maintain good document management practices:
Consistent templates with standardized properties are ensured through a central repository for all documents and workflows. For instance, one platform assists enterprises in coordinating and directing activities to meet regulatory requirements.
Traceability of ownership is ensured via secure, effective collaboration on documents and material from a single source of truth. Teams can reduce inspection time by using standardized and streamlined methods and having rapid access to data and documentation reporting.
Maintaining Continuous Quality Improvement (CQI) requires cultivating a quality culture within the firm. The greatest method to keep users engaged is to give a simple, straightforward solution that allows for process automation and standardization.
The solution one selects should be simple to configure, manage, and update, allowing them to reduce the reliance on expensive programmers, consultants, and specialized IT resources whenever they need to make a change or add a step to the process.
Change process management must be held to a high level of accuracy within certified systems. Maintaining a single source of truth within a secure file structure is critical at the file server and shared folder levels. External security risks must be addressed proactively rather than reactively, and document modifications must be mapped.