GAMP 5-aligned validation of CMMS, ERP, MES, historian and quality systems for regulated manufacturers — full IQ/OQ/PQ documentation packages meeting FDA 21 CFR Part 11 and EU Annex 11 requirements.
Pharmaceutical and regulated manufacturers rely on computerised systems — CMMS for maintenance work orders, MES for batch records, historians for process data, quality management systems for CAPA and document control. In GxP-regulated environments, these systems must be validated: their fitness for purpose demonstrated through documented evidence before they are relied upon for regulatory decisions.
In practice, many systems in regulated facilities were implemented without adequate validation, were upgraded without change control, or carry legacy validation documentation that no longer reflects the system as it operates. Regulatory inspections increasingly treat data integrity and system validation as primary risk areas.
Optimal delivers CSV programmes using GAMP 5 risk-based methodology — providing the validation strategy, documentation infrastructure and execution support to bring systems into a state of validated compliance and maintain that state through the system lifecycle.
GAMP 5 classifies software into categories that determine the validation approach and documentation burden. Optimal applies the appropriate level of rigour based on the system’s GxP impact and software category.
| Cat. | System Type | Examples | Validation Approach |
|---|---|---|---|
| 1 | Infrastructure Software | Operating systems, databases, middleware, network software | Qualification of infrastructure components; vendor records; configuration documentation |
| 3 | Non-Configured Products | Firmware, standard instruments, off-the-shelf software without configuration | IQ/OQ based on standard specification testing; limited PQ for GxP-critical functions |
| 4 | Configured Products | CMMS, ERP, MES, LIMS, QMS — configured to site requirements | Full IQ/OQ/PQ; risk-based test coverage aligned to GxP-critical functions and configurations |
| 5 | Custom Software | Bespoke applications, custom reports, tailored integration layers | Full V-model lifecycle — URS, Functional Specification, Design Specification, IQ/OQ/PQ and code review |
Optimal’s CSV programmes follow the GAMP 5 V-model lifecycle — from User Requirements Specification through to Performance Qualification and ongoing lifecycle management. The scope and documentation burden is calibrated to the system’s GAMP category and GxP impact.
For legacy systems requiring retrospective validation, Optimal conducts a gap assessment against the current state before designing the retrospective approach — avoiding unnecessary re-testing while producing a fully compliant validation package.
A regulated pharmaceutical manufacturer had operated its CMMS for seven years without adequate validation — the system had been upgraded twice without change control and the original IQ/OQ documentation did not reflect the current configured state. A regulatory inspection identified the CMMS as a critical data integrity risk, given its role in generating maintenance records relied upon for equipment qualification status. Optimal conducted a gap assessment against the current configuration, developed a retrospective validation package covering GxP-critical functions, and executed IQ/OQ/PQ testing within a 90-day programme to resolve the compliance gap ahead of the follow-up inspection.
Optimal’s CSV practitioners combine regulated industry experience with asset management and CMMS expertise — providing validation programmes that satisfy regulatory requirements while producing documentation that supports the system’s intended operational use. Prospective or retrospective, single system or site-wide validation programme.
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