FDA 21 CFR 11

Part 11 of Title 21 for The Federal Regulations Covers Electronic Records and Electronic Signatures. Any Documentation That Must Be Maintained Per FDA Regulations, But Occurs in A Digital Format, are Held To The Standards Outlines in Part 11.

Current Good Manufacturing Practices

Current Good Manufacturing Practices (CGMP) that apply to life sciences through human and animal drugs and biologics are closely monitored and reviewed under Part 11. Underlying predicate rules will dictate how records are maintained and submitted. CGMP documentation traditionally needed to be hand written following Title 21 so ensure it is recorded accurately, contemporaneously, with true data in a legible manner from an identifiable source.

CGMP
Documentation

Recorded Accurately

Record data direct from the source. No transcriptions. Multiple transcriptions opens the opportunity for more error.

Contemporaneous

Data recorded as it occurs is timely. Writing down data at the end of a shift or end of day risks missing data or errors since not everything may be recorded or recorded accurately.

True Data

Data integrity is important and all records should be true, accurate and relevant to the reporting requirements. If necessary, data may be validated or witnessed to meet this standard.

Legible Data

All records should be clear and legible, readable by anyone to avoid all guesswork.

Identifiable Source

There should be no question as to who recorded the data. Signatures, names and dates must be legible.

Transferring this to a digital format through Part 11 helps maintain these requirements, especially with integrated platforms that communicate with each other.

Transferring this to a digital format through Part 11 helps maintain these requirements, especially with integrated platforms that communicate with each other FDA 21 CFR 11.

At Digital Forge we help you select and build the solutions to fit your needs based on industry needs and the subject matter you need. While many industries overlap on compliances and best practices, we work to take the guesswork out of your strategic plan.