§111.610
§111.350
§111.255
§111.605 |
FDA has required that you keep quality records easily retrievable for at least 1 year past shelf life or 2 years after distribution. All quality documentation (MMR, BPR, equipment logs, receiving logs, COAs, distribution records, etc. must be protected with backup programs that prevent alteration and/or loss. Electronic Records are acceptable as long as they are compliant with CFR 21 part 11. |
Cloud-based electronic batch record software enables your Dietary Supplement manufacturing quality records to be instantly searchable and retrievable. DataNinja software is CFR 21 part 11 compliant – with the approved access security, audit trail, and user authentication required for part 111 record keeping compliance. Your data is safe with redundant backups and high profile encryption in a professional data center. |