FDA 21 CFR Part 11 Compliance Solution
21 CFR Part 11 governs when electronic records and signatures can be considered equivalent to paper records for FDA-regulated data. Instruments that generate GMP-critical results - TOC, CCIT, filter integrity, environmental monitoring - but lack audit trails, secure access control, or tamper-evident storage can undermine an otherwise compliant process during an FDA inspection, regardless of how good the underlying test method is.
Regulatory Basis
FDA 21 CFR Part 11 sets requirements for audit trails, electronic signatures, system access controls, and record retention for electronic GMP data. FDA's 2003 guidance on Part 11 scope and application narrowed enforcement focus onto predicate-rule records, but audit trail and data integrity expectations remain a consistent inspection focus across current Data Integrity guidance (FDA and MHRA ALCOA-plus principles).
Our Solutions
Our instrumentation is built with full audit trail logs, unique electronic signatures, multi-level user access privilege management and tamper-proof encrypted data export as standard features rather than paid add-ons, covering TOC total organic carbon analyzers, CCIT container closure integrity testers, filter integrity testers, glove integrity testers and airborne particle counters. Data integrity is designed in at the firmware level so that raw data, metadata, and audit trail remain linked and exportable together. As the manufacturer we provide lifetime free firmware updates for Part 11 function iteration, region-customized IQ/OQ/PQ validation document packages, on-site technical support for computerized system validation (CSV), and long-term data integrity compliance consultation.
Products
RTP Integrity Tester WRTP-1000
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Bag Integrity Tester
BGT-200
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Wireless Glove Integrity Tester WGT-1200
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Wireless Glove Integrity Tester WGT-2000
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Automatic Filter Integrity Tester V10
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Online and Offline Total Organic Carbon Analyzer
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Total Organic Carbon Analyzer TA-200
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CCIT-Packaging Leak Tester MFT-900
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FAQ
Q1: Does 21 CFR Part 11 apply to all lab instruments?
A1: It applies specifically to electronic records and signatures used to satisfy FDA predicate rule requirements - meaning instruments generating GMP-critical data used for batch release or compliance decisions are typically in scope.
Q2: What is ALCOA+ and how does it relate to Part 11?
A2: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) is a data integrity framework used by regulators to assess whether electronic records genuinely meet Part 11's intent, not just its technical checklist.
Q3: Can an existing instrument be retrofitted for Part 11 compliance?
A3: Sometimes, through firmware updates enabling audit trails and access control; older hardware without secure data architecture may require replacement rather than retrofit.
Q4: What is the most common Part 11 gap found during FDA inspections?
A4: Missing or incomplete audit trails - particularly the ability to show who changed, deleted, or reprocessed a result, and when - is among the most frequently cited data integrity gaps.