Add Your Heading Text Here
Ship validated software at the speed you build.
Prove it as you go.
Requirements, end-to-end traceability, Part 11 evidence, and AI-assisted authoring — living inside Azure DevOps, in the same environment as your pipelines, work items, and test plans. Audit-readiness becomes a by-product of shipping, not a project after it.
No form. No sales sequence triggered by pressing play. Engineer to engineer.
✓ evidence assembled in 0 days · it was never disassembled
Your industry is building software like a tech company.
Your evidence layer has to keep up.
Enterprise pharma is standing up new manufacturing sites in waves, running in-house AI platforms, and hiring software engineers by the thousand. Every one of those systems carries GxP validation obligations — and the delivery pace no longer tolerates evidence assembled by hand.
New GxP facilities designed around AI, ML, integrated monitoring, and data analytics mean dozens of computerized systems entering validation at once — each needing a live requirement-to-test thread from day one.
Manufacturing data fabrics, AI platforms, and digital-thread initiatives are now built, not bought. Internal teams inherit the same CSV/CSA obligations as any vendor — at sprint cadence, not project cadence.
CMOs, CDMOs, and external engineering partners touch the same lifecycle. Traceability has to hold across organizations — one source of truth, not five exported matrices.
One connected record from requirement to signed evidence
Every artifact below is a real Azure DevOps work item or a Modern Requirements virtual work item. The links are live.
Author in Smart Docs
Structured, versioned requirement documents built from work items — not Word files pretending to be a system of record. Templates enforce your URS/FRS/DS structure; every clause is a traceable item.
Baseline & lock at every milestone
Immutable snapshots of any work-item set. Locked baselines can never be edited. Compare any two and generate a Word-format difference report — your change history, auditor-ready.
Trace design, code, and test — automatically
Horizontal traceability and intersection matrices generated in seconds from live link data. Virtual work items extend tracing into test execution: Test Point, Test Run, Test Result, Test Step Run.
Review and e-sign where the work lives
Structured review workflows with 21 CFR Part 11-supporting electronic signatures. Every approval carries user identity, timestamp, and version — an approval history the system builds, not a folder someone maintains.
Produce evidence on demand
Auditor-ready traceability and compliance reports generated from live work-item activity. When an inspector — or your own quality unit — asks, the answer is a query, not a two-week reassembly project.
Collect on CSA's speed promise
FDA's shift from traditional CSV toward Computer Software Assurance rewards risk-based critical thinking over exhaustive documentation — but only for teams whose evidence is continuous. Here is the mapping, obligation by obligation.
| Obligation | What auditors expect to see | How it's produced inside Azure DevOps |
|---|---|---|
| 21 CFR Part 11 §11.10 / §11.50–.70 |
Controlled electronic records; signatures bound to records with signer identity, date/time, and meaning of signature. | Review Management applies e-signatures directly to work-item versions. Identity, timestamp, and approval action are captured on the record itself — with role-based permissions governing who can sign what. |
| GxP / CSV·CSA validation lifecycle |
Documented requirements, risk-based test coverage, and verifiable requirement-to-test linkage for every computerized system. | Smart Docs structures URS/FRS/DS as traceable items; Trace Analysis proves coverage in a live horizontal traceability matrix; gaps surface as missing links, not missing spreadsheets. |
| Change control & configuration mgmt |
Every change identified, assessed for impact, approved, and reconstructable against a known-good state. | Locked baselines anchor each milestone; Impact Analysis walks the link graph before a change lands; difference reports document exactly what moved between any two baselines. |
| Data integrity (ALCOA+) |
Records that are attributable, contemporaneous, original, and complete — not reconstructed after the fact. | Evidence is generated by the delivery process itself. Work-item history, link data, test execution records, and signatures accumulate as the team ships — original by construction. |
| Inspection readiness | Complete traceability evidence for a named system, produced without disrupting ongoing release work. | Auditor-ready reports (Smart Report, HTM exports) generate from live data in minutes. The release your team is shipping this week is untouched. |
Govern the AI. Don't ban it — and don't ignore it.
Your organization is already an AI organization. The question a quality system asks isn't "did AI help?" — it's "can you prove what it did?" Copilot4DevOps puts AI-assisted requirements work inside Azure DevOps, so every generated artifact lands in the managed lifecycle with authorship, review, approval, and trace links intact.
Built inside Azure DevOps. Not integrated with it.
Many requirements tools connect to Azure DevOps. Connection means synchronization — and synchronization is where threads break, records fork, and validation findings are born. Modern Requirements is the only requirements management platform built directly within Azure DevOps.
External RM tool, synced to ADO
- Two systems of record; sync jobs decide which one is true today
- Traceability crosses a tool boundary — matrices exported, screenshotted, rebuilt
- Separate user store, separate permissions, separate validation scope
- Evidence assembled per audit: days of reassembly, every time
- AI experiments live in a third place, outside the record entirely
Modern Requirements, native in ADO
- One system of record — requirements are work items, links are link data
- Traceability spans requirement → design → code → test execution in one graph
- Inherits ADO identity, permissions, and your existing qualified platform
- Evidence is continuous: reports generate from live state in minutes
- AI works inside the same environment, every artifact governed from birth
See the thread hold — end to end, inside Azure DevOps
A five-minute technical demo, screen-recorded in the live product: Smart Docs authoring, baseline locking, live traceability into test execution, Part 11 e-signature workflows, and Copilot4DevOps generating governed artifacts. No slideware.
Trusted in regulated engineering programs across pharma, medical devices, aerospace, and defense — built for ISO 13485, IEC 62304, FDA 21 CFR Part 820 and Part 11 environments.
