A recent warning letter states, “Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess […]
Your response is inadequate because you do not provide supporting documentation and do not include a risk assessment of the drug products manufactured and released…”
When it comes to medical device quality systems, documentation is more than just paperwork—it’s proof of compliance, product safety, and regulatory integrity. The FDA’s 21 CFR Part 820 (Quality System Regulation) outlines strict requirements for how records must be created, maintained, and controlled. Following Good Documentation Practices (GDP) helps ensure that your quality records stand up to inspection and audit.
Key Principles of Good Documentation Practices (GDP):
- Legibility & Permanence
Records must be clear, easy to read, and durable. Handwritten entries should be made in indelible ink, never in pencil. - Accuracy & Completeness
Document all work as it happens—never before, never after. Records must reflect exactly what was done, when, and by whom. - Corrections Done Properly
If an error occurs, draw a single line through the mistake, initial and date the correction, and record the accurate information. Do not erase or obscure entries. - Traceability
Every record should clearly link back to the process, product, or person it applies to. This ensures full accountability throughout the device lifecycle. - Signatures & Dates
Each entry must be signed or initialed and dated by the person performing the task, creating accountability and a defensible audit trail. - Controlled Documents
Use only current, approved versions of procedures, forms, and records. Outdated or uncontrolled copies are a common FDA finding.
Why It Matters:
Poor documentation is one of the most frequent causes of FDA 483 observations and warning letters. By embedding Good Documentation Practices into your culture, you not only stay compliant with 21 CFR 820—you also build trust in your processes, your products, and your team.
Not documenting your process or not being able to produce the documentation is the same as, if not worse than, not having a process at all. Electronic records can help facilitate the management of documentation, but only if deployed in a compliant and efficient manner. Make sure you have an expert on your team to assist in converting your paper processes to electronic batch records, procedures, and supporting documentation so that you are audit-ready. We can even help you tie your documents and batch records to training, so your people are always in compliance.
