ALCOA+, Part 11, audit trails and computerized system validation, measured against what FDA actually cites.
What 21 CFR Part 11 requires in each subpart, who it applies to, the 11.10 closed-system controls and the electronic signature rules, which requirements fall under FDA's 2003 enforcement discretion, how often FDA inspections cited Part 11 against the predicate rules from January 2025 to October 2026, and a six-step Part 11 compliance checklist.
What ALCOA stands for, what ALCOA+ and ALCOA++ add and which regulator defines each, the 21 CFR sections FDA cites when a record fails an attribute, how often those sections appeared on 779 human drug Form 483s from January 2025 to July 2026, named Form 483s with data integrity citations, and a five-step ALCOA self-inspection.
What counts as a data integrity citation on an FDA Form 483, which 21 CFR sections FDA uses for it, what ALCOA and ALCOA+ mean in FDA's 2018 guidance, and how often data integrity sections appeared on 779 human drug Form 483s citing Part 211 from January 2025 to July 2026, with US and foreign rates and named examples.
Computerized system validation is the documented, risk-based evidence that a regulated computer system works as intended and keeps its data trustworthy. This guide covers the expectations in FDA's CSA guidance, Part 11, EMA and ICH E6(R3), a seven-step lifecycle, concrete OQ audit trail test cases, vendor and periodic review controls, and Atlas data on how often FDA cites computerized systems and data integrity.
Computer System Validation proves software works through specifications and scripted tests; Computer Software Assurance sizes the effort to risk. This guide covers FDA's four-step CSA approach, a five-stage governance model, how to apply it to EBR, MES and LIMS, hybrid strategies, the records inspectors ask for, and how often FDA cites computerized-system controls.
ALCOA+ for AI and Digital Systems.
Atlas
In 2025, the principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available, Traceable) are...
What Is an EDMS?
Atlas
An EDMS (electronic document management system) is the software that controls a regulated company's procedures, specifications and records from draft to retirement. This guide covers the meaning and full form, the five types, the 21 CFR Part 11 and Annex 11 controls a GxP EDMS needs, the document lifecycle, how an EDMS differs from a QMS and a LIMS, and how often FDA cites document control on Form 483s.