eQMS Validation: GAMP 5, CSA, 21 CFR Part 11

For a SaaS eQMS with a pre-validated platform, customer-side validation typically takes weeks rather than months. The duration depends on three factors: how much of the validation work the vendor has already completed, how unique your configuration is, and whether you validate all modules at once or in phases. Pre-validated platforms like Scilife handle up to 95% of the underlying validation effort, leaving a focused customer-side scope of intended use, configuration, and supplier qualification.

21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures in regulated industries. Any eQMS used to manage GxP records for the US market must comply with Part 11 — including controls around audit trails, electronic signatures, system access, and data integrity. Validation activities must produce documented evidence that the eQMS meets these requirements. A Part 11–compliant SaaS eQMS provides this evidence in its validation package, so customers don't need to build the proof from scratch.

Both. In a SaaS shared-responsibility model, the vendor validates the underlying platform, infrastructure, and standard workflows. The customer validates their specific intended use, configuration choices, and processes. No SaaS vendor can deliver a 100% validated system, because intended use is unique to each customer. Reputable vendors provide a complete, signed-off validation package that customers leverage as the foundation for their own validation work.

A complete vendor validation package typically includes ten core documents: a Validation Plan, User Requirement Specification (URS), Risk Analysis, Configuration Specifications, Test Plan, Installation and Operational Qualification (IQ/OQ), Performance Qualification (PQ), Traceability Matrix, Test Summary Report, and Validation Summary Report. All should be drafted, executed, and signed off by the vendor — and designed to serve as the foundation for the customer's own validation activities, not a starting point to rebuild.

Yes — phased validation is fully compliant and often the recommended approach for first-time eQMS implementations. Going live with one or two modules first (typically Document Control and Training), then adding modules over time, lets QA teams build validation experience gradually rather than tackling everything at once. The trade-off is multiple smaller validation events versus a single large one. Auditors accept either approach, provided each phase is properly documented.

Validation is a continuous activity, not a one-time exercise. SaaS vendors typically categorise releases as minor (bug fixes, no functional change), medium (feature improvements), or major (substantive functional change). For minor releases, customers usually need only to review release notes and document the change. Medium and major releases trigger a change control event with corresponding validation activities. A well-run SaaS eQMS provides release notes and impact assessments for every release, so the customer-side effort is proportional to actual change.

Yes. Scilife is validated as a SaaS platform on AWS using a GAMP 5 and Computer System Validation approach, with full alignment to 21 CFR Part 11 requirements for electronic records and electronic signatures. Customers receive a complete, executed, signed-off validation package as the foundation for their customer-side validation. The platform supports compliance with GMP, GDP, GLP, GCP, ISO 13485, EU MDR/IVDR, and UK MDR/IVDR.

GAMP 5 is the industry-standard framework for validating computerised systems in the life sciences, published by ISPE. It defines a risk-based, lifecycle approach to validation — categorising software by complexity and configurability, and scaling validation effort accordingly. For SaaS eQMS platforms like Scilife, GAMP 5 is the methodology auditors and inspectors expect to see applied. A vendor validated to GAMP 5 has performed a structured set of validation activities you don't have to repeat.

If your company operates under GxP regulations (GMP, GLP, GCP, GDP), 21 CFR Part 11, EU MDR/IVDR, ISO 13485, or similar standards, then yes — any system used to manage regulated quality records must be validated. The first step is a criticality assessment: a structured questionnaire that identifies which regulations apply to your business and what validation effort is appropriate. The result determines whether validation is required and, if so, at what depth.

A validation lifecycle management system maintains a system's validated state over its entire lifecycle, not just at initial go-live. Scilife does this by validating the platform, documenting every release with impact assessments, and managing changes through a controlled release process, so your eQMS stays validated as it evolves.