For computerized systems (DMS, ERP, WMS, QMS, MES, CDS, LIMS, EMS, SCADA, PLC, etc.) operated at our partners subject to pharmaceutical regulation, we perform data integrity assessments proportionate to the system's criticality and complexity—in accordance with EU GMP Annex 11 and 21 CFR Part 11 requirements—and we perform or support as experts the computerized system validation (Computerized System Validation, CSV).
In our work we apply the guidance of the second edition of GAMP5 (GAMP5 SE), using a risk-based approach that reasonably leverages supplier documentation, while also following pharmaceutical terminology (GxP IT – URS, FS/DS, IQ, OQ, PQ, traceability matrix).
System data integrity assessments along the ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available): examination of audit trails, access management, electronic signatures and privilege matrices, identification of gaps and corrective actions.
Preparation or review of validation plans, user requirement specifications (URS), risk assessments, functional and design specifications, IQ/OQ/PQ protocols and reports, traceability matrix and validation closure report.
Supplier audit and assessment, classification of the system into a GAMP software category, leveraging supplier documentation, and risk-proportionate allocation of validation resources.
Maintaining the validated state: periodic review, change control, configuration management, support for backup/restore and business continuity procedures.
A data integrity assessment examines whether the data generated in the system comply with the ALCOA+ principles (e.g., audit trail, permissions, electronic signature). Validation is broader: it documents that the system operates reliably for its intended purpose throughout its entire lifecycle (IQ/OQ/PQ).
No. The extent of validation is risk-based and adjusted to the system's GxP criticality and complexity. A simple configurable software requires a different scope than a custom-developed, production-controlling system.
ISPE GAMP5 is the industry guidance for validation of computerized systems. The 2022 second edition places greater emphasis on critical thinking, agile and cloud-based solutions, and the reasonable use (leverage) of supplier documentation.
Yes, after an appropriate supplier assessment, the supplier's tests and documents can be largely credited, avoiding parallel work. We always substantiate this with a risk assessment.
The validated state is not a one-time event but requires continuous maintenance: change control, periodic review, configuration and backup management. Significant changes (version change, migration) require partial or full revalidation.
We help with the data integrity assessment and full validation of your computerized systems—either as a one-time project or as ongoing expert support. Contact us!
