How an electronic batch record system supports 21 CFR Part 11, EU GMP Annex 11, cGMP and data integrity, and a GAMP 5 approach to validation, and what stays the manufacturer's responsibility.
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Get the whitepaperWhat you will learn
- Which Part 11 controls for electronic records the system enforces, clause by clause (§11.10)
- How electronic signatures work: the signer's password at each signature, the meaning, the lockout (Subpart C)
- What the system enforces during a batch: limits, cleared operations, the order of steps, deviations
- A tamper-evident audit trail and ALCOA+ in practice
- A GAMP 5 approach to validation: IQ with each release, then your OQ and PQ
- Where the system's part ends and the manufacturer's procedures and validation take over
Why this paper
A computerised system is not "Part 11 compliant" by itself: compliance comes from the system's controls together with the manufacturer's procedures and validation. This paper sets out clearly what the system contributes.
Atto Pharma eBMR turns a site's own approved Word or PDF batch manufacturing and packing records into electronic screens, and records the batch on them: dispensing, lot processing, in-process checks, packing, reconciliation, review and release. Atto eLogbooks does the same for equipment, utilities, HVAC, maintenance, calibration and cleaning logbooks.
What it covers
- 21 CFR Part 11, Subpart B (electronic records) and Subpart C (electronic signatures)
- Current Good Manufacturing Practice (21 CFR 210/211, EU GMP and its Annex 11) and data integrity
- A GAMP 5 approach to computerised system validation
- The responsibilities of the system and of the manufacturer, side by side
The rules the paper describes are enforced by the database itself, unless it says otherwise: they hold even if the screens were bypassed.
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