Imagine a world not unlike the corridors of a wizarding school, only here the spells and incantations are replaced with compliance regulations and audits. Here, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are revered sorcerers, safeguarding the enchanted, yet perilous world of life sciences.
The two pillars: FDA and FTC
The FDA primarily focuses on ensuring the safety and efficacy of drugs and medical devices, while the FTC enforces antitrust and consumer protection laws. According to the official FTC website, both agencies require stringent record-keeping across various aspects of a company's operation, from product development to marketing and antitrust behavior. Failing to maintain accurate records can result in severe consequences, including substantial fines and legal actions.
Documents and records
As mentioned, ensuring compliance with regulations, and maintaining quality standards is crucial. A critical component of this ecosystem is the diligent maintenance of documents and records. Take for instance medical devices, records not only serve as evidence of compliance but also act as a detailed blueprint for the manufacturing, quality assurance and servicing of the devices. Accurate record-keeping is essential for the traceability and accountability of devices, especially when discrepancies or issues arise.
Now, let's explore the need-to-knows for maintaining records.
Records - general requirements
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Records should be maintained at the manufacturing site or a reasonably accessible location.
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They should be legible, stored securely, and backed up.
Record retention
Records must be retained for the expected life of the device or at least 2 years from the date of release for commercial distribution.
Device master record
Must include:
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Device specifications
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Production and process specifications
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Quality assurance procedures
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Packaging and labeling specifications
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Installation, maintenance and servicing procedures
Device history record
Must include dates of manufacture, quantity manufactured and distributed, and acceptance records.
Quality system record
To be prepared in accordance with 21 CFR 820.40 and should include or refer to documentation of activities not specific to a particular device.
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