21 CFR Part 11 Compliance for Life Sciences AI on AWS

Close the 21 CFR Part 11 gap for AI/ML workloads — before FDA inspection finds it.

Kriv AI delivers a 4-week virtual readiness assessment purpose-built for life sciences organizations running AI/ML workloads on AWS. Pharmaceutical, biotech, medical device, and CRO teams increasingly deploy machine learning across clinical trials, pharmacovigilance, GMP manufacturing, and Software as a Medical Device (SaMD). When those systems generate, modify, or maintain electronic records or electronic signatures subject to FDA jurisdiction, 21 CFR Part 11 applies. Misalignment surfaces during FDA inspections, BIMO audits, and Form 483 observations — typically late, expensively, and with program delays.

This engagement closes that gap before inspection. Over four weeks, Kriv consultants map your AI/ML pipeline against Part 11 Subpart B controls (electronic records) and Subpart C controls (electronic signatures), overlay FDA's Dec 2024 final PCCP guidance for AI-enabled device software, and produce a deliverable package your Quality and Regulatory teams use as validation inputs.

4-week schedule:

Week 1 — Scoping. System inventory, intended-use classification, GAMP 5 risk categorization, ALCOA+ gap review (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available). Week 2 — Gap analysis. Controls assessment against Part 11 §11.10 controls, §11.30 open systems, §11.50 signature manifestations, §11.70 signature/record linking, §11.100/200/300 electronic signatures. AI-specific concerns: training data lineage, model versioning, drift monitoring, human-in-the-loop governance. ICH E6(R3) overlay for clinical trial scope (adopted Jan 2025). Week 3 — AWS control architecture. Hash-chained audit trail design (S3 Object Lock WORM + CloudTrail + KMS-signed). Electronic signature binding design. AI model change control under PCCP. Validation protocol drafting (IQ/OQ/PQ scaffolds). Week 4 — Readout + handoff. CSV protocol templates, validation vendor referral list, 30-day follow-up.

Deliverables: 40-page Readiness Report · Part 11 control matrix + gap register with severity ratings · CSV validation input templates (URS/FRS stubs, traceability matrix, IQ/OQ/PQ protocol skeletons) · ALCOA+ control mapping · PCCP documentation template (Tier 3, Modification Protocol + Impact Assessment per Dec 2024 FDA guidance) · AWS-native evidence architecture (HealthLake, CloudTrail, S3 Object Lock 6-year WORM, KMS, optionally HealthOmics for genomic pipelines) · validation vendor referral list.

Three tiers aligned to intended use:

Clinical Trial Systems ($25,000): EDC-adjacent AI, eTMF classifiers, clinical data processing; ICH E6(R3) overlay Pharmacovigilance / GMP Manufacturing ($32,500): safety signal detection, batch release analytics, deviation management; full Part 11 + ALCOA+ AI/ML SaMD ($40,000): FDA-regulated medical device software with PCCP scaffolding; submission strategy

Differentiators. AWS Select Tier Services Partner, Databricks Partner, and member of the Anthropic Claude Partner Network (April 9, 2026). White space: as of listing publication, no other AWS Marketplace professional services listing combines 21 CFR Part 11 scope with AI/ML-specific assessment methodology.

Important disclaimers. Kriv AI prepares readiness assessments, gap analyses, and validation input templates. Kriv AI does NOT perform formal Computer System Validation (CSV) execution, does NOT sign validation protocols as the regulated user, and does NOT make regulatory submissions on the customer's behalf. Formal CSV execution, protocol approval, and FDA interaction remain the customer's responsibility under their Quality Management System. Not legal, regulatory, or clinical advice. AWS infrastructure consumption (HealthLake, HealthOmics, S3, CloudTrail, KMS) is billed separately by AWS. Trademarks: "21 CFR Part 11" references the United States Code of Federal Regulations and is used for identification only; no affiliation with or endorsement by the FDA is claimed or implied.