Validating an ALM for GxP: a practical CSV framing

Regulated teams do not just buy an ALM — they validate it for intended use. Whether you follow classic IQ/OQ/PQ language or the FDA’s newer Computer Software Assurance (CSA) risk-based framing, the goal is the same: documented evidence that the system does what your process requires, reliably. This guide is practical framing for validating requirements/ALM platforms — not a substitute for your validation SOP or legal counsel.

For electronic records and signatures specifically, start with FDA 21 CFR Part 11. Vendors provide technical controls; your organization owns procedural controls and the validation package.

What you are validating (intended use)

Write intended use in plain language, for example:

• Author and baseline requirements, tests, risk, and (if in scope) architecture/SBOM
• Maintain traceability and coverage views for design control / IEC 62304
• Apply approval chains and e-signatures on defined transitions
• Retain audit trails and export inspection copies
• Import/export via ReqIF, CSV, Excel, Word, CycloneDX/SPDX as used in your process

Out of scope belongs in writing too (e.g. “not used for clinical EDC”).

Risk-based focus (CSA-aligned thinking)

Spend depth where failure harms patients, product quality, or data integrity:

Higher assurance attention	Lower (still controlled)
E-signature binding, audit trail integrity	Cosmetic UI layout
Access control / RBAC	Optional dashboards
Traceability integrity / suspect behavior	Non-regulated reporting themes
Import mapping for regulated data migration	One-off admin convenience scripts

A lean validation outline

1. Validation plan — scope, roles, risk assessment, environments.
2. Requirements / user requirements specification — what the ALM must do for your SOPs.
3. Configuration spec — item types, workflows, signature rules, projects.
4. IQ-style — installed/configured in the target environment (cloud tenant or self-hosted), security settings, backups.
5. OQ-style — challenge critical functions: create/revise items, links, coverage, suspect flags, signature re-auth, audit trail review, exports.
6. PQ-style — run a realistic pilot project through your procedure (including a sample design-controls package).
7. Traceability — validation requirements ↔ test scripts ↔ results.
8. Release / change control — how you re-validate after vendor upgrades.

Exercise electronic signatures and approval chains in OQ/PQ if Part 11 is in scope — do not only screenshot the dialog.

Migration and import are in scope

If you will bring legacy data from Jama, DOORS, Polarion, TestRail, etc., include Import Center scenarios in OQ: field mapping, ReqIF type mapping, link import, preview, and rollback/re-import behavior. The migrate-from-* guides describe the operational path; validation proves your configuration of that path.

What to ask the vendor for

• Security and quality documentation (SOC reports, SDLC overview) for your supplier assessment
• Description of Part 11 technical controls actually implemented
• Release notes and known-issue process for ongoing change control
• Export of audit trails and signed records for inspection support

They cannot hand you a completed PQ. They can make PQ cheaper by shipping governed defaults.

Related reading

• FDA 21 CFR Part 11
• Electronic signatures and approval chains
• Import requirements
• Trust Center
• Platform overview