TetraScience GxP Validation & 21 CFR Part 11 Compliance
Empowering pharmaceutical and life science organizations with cutting-edge AI solutions.
Validation Deliverables for TetraScience
Validation Master Plan
Overall validation strategy, GAMP 5 category justification, scope, schedule, responsibilities, and risk-based approach. Signed by QA, IT, and scientific owners before configuration begins.
URS & Functional Spec
User Requirements Specification in scientist language, Functional Specification mapped to Tetra capabilities, and a traceability matrix linking every requirement through test to evidence.
Risk Assessment
ICH Q9(R1) aligned risk assessment for tenant configuration, Tetra Integrations, and each custom pipeline. Drives test depth proportional to actual patient-safety risk.
IQ/OQ/PQ Test Scripts
Installation, Operational, and Performance Qualification scripts executed in the qualified environment with documented evidence, deviation handling, and sign-off by QA.
Pipeline Test Packages
Per-pipeline test packages with unit tests, integration tests, and golden-file regression tests. CI evidence is part of the validation record for every release.
Validation Summary Report
Final VSR summarizing all validation activity, open items, and formal release for production use. Signed by the quality unit and retained as the primary inspection-ready artifact.
Part 11 and Annex 11 in One Package
We produce a single integrated validation package satisfying 21 CFR Part 11 and EU GMP Annex 11 without duplicate testing. Every requirement is traceable from regulation through URS through test evidence to signed-off release.
ALCOA+ as a Design Principle
ALCOA+ is not a checklist applied at the end — it is a design principle for every Tetra data flow. Deterministic ingestion with checksums, immutable IDS audit trail, controlled pipeline versioning, and enforced retention all feed configuration decisions on day one. See the MHRA GxP Data Integrity guidance and the FDA Data Integrity guidance.
Scoped to Actual Risk
We never over-validate. ICH Q9(R1) risk-based validation means Category 4 platform configuration gets appropriate testing and Category 5 custom pipelines and AI components get deeper review — not the other way around. That keeps timelines realistic while still meeting inspection expectations.
Regulatory Frameworks We Cover
FDA 21 CFR Part 11
Electronic records and signatures for products marketed in the United States. Foundational regulation governing every TetraScience GxP workflow in scope for FDA-regulated activity.
Learn moreEU GMP Annex 11
Computerized systems in GMP environments for the European market. Adds explicit risk management, supplier management, incident handling, and periodic review expectations.
Learn moreISPE GAMP 5 Second Edition
Industry-standard framework for risk-based CSV. Published 2022, widely accepted by FDA and EMA inspectors. Sets the structure for all our TetraScience validation packages.
Learn moreICH Q9(R1) Quality Risk Management
Updated ICH risk management guidance finalized 2023. We use Q9 principles to scope validation effort, set test depth, and justify accepted residual risk for pipelines and AI.
Learn moreMHRA & WHO Data Integrity
ALCOA+ data integrity expectations from MHRA and WHO. Practical controls on deterministic ingestion, audit trail integrity, and record retention across the Tetra data flow.
Learn moreFDA & EMA AI Guidance
FDA 2025 draft guidance on AI for regulatory decision-making and EMA reflection paper on AI in the medicinal product lifecycle. Applied to any AI agent on Tetra Data.
Learn moreOur Validation Approach
We run validation in parallel with implementation, not after it. This is how GAMP 5 Second Edition intends CSV to work in an agile world — risk-driven, incremental, and based on critical thinking rather than rote test execution. The result is faster time to go-live without sacrificing inspection readiness.
Plan Early
Validation Master Plan and category justification produced during discovery — before configuration starts — so scope is agreed upfront with QA.
Test Incrementally
IQ/OQ/PQ execution runs slice-by-slice alongside implementation. Each quarterly capability ships validated, not retrofitted at the end.
Operate Continuously
Periodic review, change control, and incident handling embedded into the operate phase so the validated state is maintained after go-live.
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Inspection Readiness Checklist
Signed VMP & VSR
Validation Master Plan and Validation Summary Report signed by QA, IT, and scientific owners, indexed for rapid retrieval during inspection.
Traceability Matrix
Every requirement traced from URS through functional spec, test case, executed evidence, and final release — no orphan requirements, no untested features.
Executed IQ/OQ/PQ
Test scripts with documented evidence, deviation handling, and sign-offs. Re-tests for any deviations are linked to the original script and re-executed.
Pipeline CI Evidence
Per-pipeline CI test results retained as part of the validation record. Every release has documented unit, integration, and regression test results.
Periodic Review Log
Current periodic review with change history, incident review, access review, and sign-off. Keeps the validated state current, not just current at go-live.
Supplier Assessment
Documented supplier qualification for TetraScience and AWS, including current SOC 2 Type II reports and the layered shared responsibility model.
Related Reference Materials
FDA Part 11 Guidance
FDA guidance on Part 11 scope and application, clarifying enforcement discretion and narrowing the set of records strictly subject to Part 11 in practice.
ICH Q10 Pharmaceutical Quality System
ICH Q10 pharmaceutical quality system expectations. Provides the QMS context into which TetraScience validation fits across the product lifecycle.
ISPE GAMP Data Integrity GPG
ISPE Good Practice Guide on Records and Data Integrity. Reference for implementing ALCOA+ in configured GxP systems including scientific data platforms.
PIC/S PI 041
PIC/S guidance on good practices for data management and integrity in regulated environments — used by many non-FDA/EMA inspectorates globally.
WHO Data Management
WHO Technical Report Series 996 Annex 5 — good data and record management practices. International baseline for data integrity expectations.
EMA AI Reflection Paper
EMA reflection paper on the use of AI across the medicinal product lifecycle — foundational reference for validating AI agents on TetraScience data.
Frequently Asked Questions
The Tetra Data Platform provides the technical controls required by 21 CFR Part 11 — audit trail, access control, record retention — but compliance is a shared responsibility. The vendor validates the platform; you validate your tenant configuration, Tetra Integrations, custom pipelines, IDS contracts, and SOPs. We deliver the full customer-side validation package under ISPE GAMP 5 Second Edition so the deployment is inspection-ready from go-live.
The Tetra Data Platform sits primarily at Category 4 (configured) for the platform itself and pre-built Tetra Integrations. Custom Tetra Pipelines and custom Connectors sit at Category 5 (custom). IDS schema design for net-new domains is a Category 5 artifact because it defines a new data contract. We produce the GAMP 5 category justification as part of the validation master plan so validation effort is proportional — appropriate for configuration, deeper for custom code.
A full TetraScience validation package contains: Validation Master Plan, User Requirements Specification, Functional Specification, Configuration Specification, Risk Assessment using ICH Q9(R1) principles, Traceability Matrix, IQ/OQ/PQ test scripts with executed evidence, IDS contract documentation, Pipeline test packages, Supplier Assessment, Validation Summary Report, and a Periodic Review procedure. All artifacts map to the GAMP 5 framework.
We map every Part 11 requirement — §11.10 controls, §11.30 open systems, §11.50 signature manifestations, §11.70 record/signature linking, §11.100 and §11.200 signature components — to explicit Tetra configuration and SOP controls. The Tetra Data Platform handles audit trail and access control natively; our job is to configure them correctly, document the mapping, and test that every control works as intended. See the full text of 21 CFR Part 11 and FDA Part 11 Scope and Application guidance.
For EU programs we layer EU GMP Annex 11 on top of Part 11. Key additions include risk management (Annex 11 §1), supplier management (§3.1), incident management (§13), and periodic review (§11). For TetraScience specifically, supplier management is non-trivial because it covers both TetraScience as the platform vendor and AWS as the underlying infrastructure host. Our validation approach produces a single integrated package satisfying both Part 11 and Annex 11 without duplicate work.
We apply ALCOA+ — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available — to every Tetra data flow. Practical controls include: deterministic file ingestion with checksums, immutable IDS audit trail, controlled pipeline versioning so harmonization logic is traceable, and periodic record retention checks. See also the FDA Data Integrity and Compliance guidance and the WHO Good Data Management practices.
Tetra Pipelines are Python code running on the platform — Category 5 under GAMP 5. We treat them like production software. Every pipeline ships with unit tests covering core transformation logic, integration tests covering end-to-end IDS contract behavior, deterministic golden-file regression tests for representative inputs, and documented release notes per version. Pipeline deployment is gated by a CI process that produces test evidence as part of the validation record. Changes follow change control under Annex 11 §10.
IDS schemas are data contracts and we treat them like API versions. New IDS schemas go through a formal review covering scientific accuracy, downstream consumer impact, and metadata completeness. Schema versioning follows semantic versioning; breaking changes require migration plans for existing records. Validation evidence includes schema review minutes, downstream impact analysis, and documented test cases for any consumer affected. See the IDS documentation for the underlying structure.
AI components are treated as Category 5 under GAMP 5 Second Edition with additional controls — model versioning, prompt versioning, evaluation harness results, drift monitoring, and explicit scope boundaries. We also align with the FDA January 2025 AI draft guidance and with the EMA reflection paper on AI in the medicinal product lifecycle. Our TetraScience AI integration service ships AI with this validation package included.
Migration into TetraScience is one of the highest-value steps in any program because it unlocks AI use cases that were previously impossible. We produce a Data Migration Plan (scope, source-to-IDS mapping rules, tolerances, roll-back), run reconciled migration dry-runs in a qualified environment, and produce a Data Migration Report with record counts, checksum comparisons, and exception handling. Special attention goes to instrument firmware version differences and historical file format variations that often produce edge cases not seen in current data.
We establish periodic review per GAMP 5 Appendix O8, typically annual for the Tetra Data Platform tenant and active Tetra Integrations, semi-annual for high-risk custom pipelines and AI components. Each review covers change history, incident review, access review, evaluation metric review (for AI), training status, and SOP alignment. Findings feed into the next quarterly release cycle. See also the PDA regulatory resources for background on periodic review expectations.
We produce a Supplier Assessment for TetraScience as part of the validation package, covering the vendor quality management system, SOC 2 Type II reports, penetration testing posture, and incident response. We also document the AWS shared responsibility model since the Tetra Data Platform runs on AWS. This aligns with ISPE GAMP Good Practice Guide on IT Infrastructure and with ICH Q10 pharmaceutical quality system expectations. For hosted Tetra services we document the layered shared responsibility — TetraScience-managed, AWS-managed, customer-managed — so inspectors can see which controls sit where.
Get Your TetraScience Deployment Inspection-Ready
Full GAMP 5 validation for Tetra Data Platform tenant, Tetra Integrations, custom pipelines, and AI agents. See also TetraScience services and AI integration.
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