FDA has announced (08-July-2010) that “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance).”
It has been about seven years that US-FDA has debated 21 CFR Part 11 requirements and began using “Enforcement Discretion.”
FDA announced that: “The Agency expects to begin conducting the Part 11 focused inspections soon.”
Check now your 21 CFR Part 11 compliance status with our CCS services:
- 21 CFR Part 11 assessment plans and checklists
- Company Policy for electronic records and signatures
- Verification of your document management strategies and methodology (review, approvals, distribution)
- Detailed and risk-based approach of production records, such as Master Batch Records, Calibration Records, Laboratory Records (refer to 21 CFR Part 211, Subpart J: records)
- Validation status check of each relevant system including upgrades and up-to-date product White Papers
- Training needs and Part 11 awareness
- Pre-Audit execution focused on 21 CFR Part 11
Contact right now talk@comes-compliance.com and get more information about our services dedicated to 21 CFR Part 11 compliance and inspection readiness.
By planning and verifying your 21 CFR Part 11 compliance concept, you will be better prepared to respond appropriately and efficiently to FDA auditors’ questions.