Pharma & Life SciencesA validated state you can show.
Agents4DevOps applies GAMP 5 category and risk context, URS, FS and DS structures, Part 11 and Annex 11 controls, ALCOA+ data integrity, IQ/OQ/PQ qualification, deviations, validated-state baselines and Quality Unit review to governed agent workflows in Azure DevOps. Agents do the preparation. The Quality Unit keeps the authority.
No card required. Your data stays in your Azure DevOps tenant.
- GAMP 5
- GxP / cGMP
- 21 CFR Part 11
- EU Annex 11
- ALCOA+
- ICH Q9
The agent supports the process. The Quality Unit decides.
Computerized-system work under GxP depends on a long list of connected things: intended use, patient, product and data impact, supplier and system category, risk-based assurance, approved requirements and specifications, qualification, deviations, electronic records and signatures, change control, periodic review, and the evidence that the system is still in a validated state. When any of them drifts, the validated state is in question. Most teams keep that chain together with manual reviews and a traceability matrix that is out of date the week after it is signed.
- 01
Specifications drift from the URS.
A URS line is clarified, and the FS, DS and qualification tests that implement it keep the old wording until a reviewer notices.
- 02
Assurance depth is decided once.
Risk-based test depth is set at the start of validation and rarely revisited when a change makes a function more critical.
- 03
Deviations close without their evidence.
A failed OQ step becomes a deviation, the fix ships, and the link between deviation, remediation and retest is reconstructed for inspection.
- 04
Inspection prep stops the team.
Assembling source-linked validation evidence for the Quality Unit takes days of manual collection across tools and documents.
GxP context in every run.
The Pharma pack sets the classification, traceability, standards mapping and gates the agents follow. Your team sets the triggers and the approvers.
- 01 Classification
GxP applicability and impact
GxP applicability, system or software category, patient, product and data impact, record and signature criticality, data-integrity risk, supplier and configuration context, and validation stage.
- 02 Traceability model
From process need to validated state
Process need to URS, functional and design specification, risk and control, configuration and build, IQ/OQ/PQ or assurance test, deviation resolution, approval, and the validation summary.
- 03 Standards & frameworks
Mapped to the GxP frameworks you use
GAMP 5, GxP and cGMP context, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, ICH Q9 quality risk management, and Computer Software Assurance and risk-based assurance context.
- 04 Lifecycle gates & evidence
The gates validation already runs
Validation plan, requirement and specification review, risk assessment, supplier and configuration review, IQ/OQ/PQ readiness, deviation closure, electronic-record and signature control, validation summary, and the change or revalidation decision.
The Pharma chain, kept intact.
A URS line changes. The agent flags the stale specification, raises revalidation actions, and confirms the chain before the validated state moves.
- Process need
- URS
- FS / DS
- Risk control
- Configuration
- IQ/OQ/PQ
- Deviation closure
- Validated state
Where the agents do the work.
Eight workflows the pack is configured for. Each one runs inside Azure DevOps and leaves its output on the work item, test plan or wiki page your validation team already uses.
URS and specification quality
Draft, classify, validate and link URS, FS, DS and acceptance criteria with GxP and data-integrity context attached.
Business Analyst Agent
Risk-based assurance
Identify critical functions and controls, propose verification depth, link risk to tests and evidence, and prepare the review.
Requirements Engineer Agent
IQ/OQ/PQ planning and evidence
Generate and maintain qualification tests, configurations, runs, deviations, results, approvals and RTM coverage, with per-step outcomes recorded.
QA Engineer Agent
Electronic records and signatures
Check the configured access, audit-trail, signature, record, retention and approval evidence.
Compliance Officer AgentDeviation and defect management
Triage failures, assess validation impact, create deviations, verify remediation and update the evidence.
QA Engineer Agent
Validated-state change control
Analyze configuration and software changes for revalidation needs, affected records, approvals and release controls.
Release Manager AgentData-integrity audit
Check that represented evidence is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
Compliance Officer AgentInspection readiness
Audit traceability and assemble source-linked validation and control evidence for Quality Unit review.
Compliance Officer Agent
Fourteen roles, configured for GxP work.
The supplied catalog includes these role configurations for Pharma and Life Sciences. Use one as shipped, or fork it and edit its instructions in plain English.
Business Analyst Agent
Drafts and classifies URS, FS and DS entries with GxP applicability and data-integrity context attached.
TestQA Engineer Agent
Prepares IQ/OQ/PQ scripts from approved requirements and records step results and deviations in Test Plans.
GovernCompliance Officer Agent
Checks Part 11 and ALCOA+ evidence and assembles inspection-ready packages for the Quality Unit.
ReleaseRelease Manager Agent
Holds validated-state changes until revalidation actions and approvals are complete.
Pharma roles in the catalog
- Acceptance Coordinator
- Business Analyst
- Compliance Officer
- Configuration Manager
- Engineering Manager
- Product Owner
- Project Manager
- QA Engineer
- Requirements Engineer
- Risk Manager
- Software Architect
- Team Assistant
- Technical Writer
- Test Engineer
A GxP-relevant requirement changes.
A process owner updates URS-118, the requirement for batch record sign-off. The agent's condition matches and the run starts. It reads the URS line, its GxP applicability and system category, then identifies the affected FS and DS entries, risk controls, qualification tests, electronic record and signature controls, open deviations, the approved baseline and the validation summary. It finds an OQ test written against the old wording and a signature control that the change now touches. It prepares the revalidation actions on the right items and routes them to the Quality Unit as an open task. The validated state is not updated until that review is done and the agent has verified the links.
run started · URS-118 updated
GxP: yes · category 4 · record critical
tracing: 2 FS · 1 DS · 6 OQ · 1 e-sig
finding: OQ-31 uses superseded wording
checkpoint · revalidation to Quality Unit
record · validated state unchanged
- ✓ FS and DS linked and current
- ✓ Risk control reassessed
- ! OQ tests match the change
- ! E-signature control checked
- ✓ Open deviations reviewed
The Quality Unit keeps authority.
Agents prepare specifications, trace risk, draft qualification scripts and assemble evidence. System owners, process owners, validation, QA and the Quality Unit keep responsibility for GxP applicability, risk, validation strategy, deviation disposition, release and inspection statements. Required Approval pauses a run and opens a task for the named reviewer, who can answer, attach supporting files, and approve, edit or reject before anything is written.
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Pharma and Life Sciences questions.
No. It helps run and document the validation workflow you configured. Your organization and Quality Unit approve the strategy, the evidence, the deviations and the conclusion.
It can prepare test scripts from approved requirements and risk controls. Test owners review, execute, document and approve them under your quality system. Step-level outcomes can be recorded in Azure DevOps Test Plans.
It checks the controls and approval and evidence records that are represented in Azure DevOps. Product and process suitability, technical controls, procedures and validation remain your responsibility.
Yes. Attach SOPs, templates and terminology as knowledge, or turn on Bring Your Own Data so the agent retrieves from your uploaded documents, queries and wiki pages during the run. Every agent definition is versioned with rollback.
Yes. Each run keeps its trigger, the artifacts it read, the tools it used, proposed and completed actions, approval state, output, errors and verification result in the Job Explorer.
No. Agents run inside your Azure DevOps environment on the Copilot4DevOps security and trust model. Your project data is not used to train models.
Credits are $0.01 each, pooled across your organization, with no per-user fees. A rule-shaped check, such as required links on every URS item, can run as an Execution Agent at a flat 4 credits. Agents pause cleanly at zero.
Bring a real URS change to the demo.
Start a free trial with 2,000 credits, no card required. Or book a 30-minute demo with a requirement, deviation, test or evidence gap from your own project, and watch the classification, trace, Quality Unit checkpoint and run record live.
