In August 2003, the FDA issued the document "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application", which shared the Agency's current thinking regarding the scope and enforcement of 21 CFR Part 11 Electronic Records; Electronic Signatures. The guidance document assured a concerned industry and its suppliers that fewer records would be subject to the regulation, and that there would be some discretion when it came to enforcement of the requirements for validation, audit trails, record retention, record copying, and legacy systems (i.e., those systems in operation before Part 11 become effective in August 1997). This was to last until the Agency had time to re-think the regulation. Though many important aspects of Part 11 would still be enforced, they were more readily complied with, and the industry and its suppliers breathed a sigh of relief... and began to ramp up compliance, not knowing if/when the Agency would re-issue the regulation and begin full enforcement.
That breather may be about to come to an end.
The FDA has indicated that they will shortly release their approach to inspecting Part 11 controls. Their inspections will be used to revise the Part 11 regulations.
In anticipation of increased focus on the part of the agency, Tanis has released the first in several documents intended to help our customers understand the regulation. Our first document in the series is An Introduction to 21 CFR Part 11 (if you have not already registered and signed-in, click here to register and gain access to your copy). Other documents will follow, as will updates to our existing documents as the regulation is updated or guidance is released, so subscribe to our newsletter while you're at it and stay completely informed.
