Software validation for pharmaceutical production
The EXCO team has conducted the validation of a process control system of a production system, which includes GMP and non-GMP relevant components and equipment parts for controlling and monitoring all necessary processes.
Tasks
EXCO has completed all tasks of the validation of computerized systems in the regulated environment of the
pharmaceutical industry for a customer project. To ensure that all requirements in accordance with GAMP 5, ISO 13485, FDA 21 CFR Part 11 and the EU GMP guidelines Part 2 are met, EXCO validated the customer's software systems and the software and created complete documentation to ensure traceability and risk minimization.
Implementation
- Functional Design Specification (FDS)
- Supplier qualification
- Risk analysis
- Creation of the process description
- Creation of a process FMEA
- Creation of a validation master plan (VMP)
- Planning and implementation of qualifications: DQ, IQ, OQ, PQ and process validation (PV)
- Creation of a complete traceability matrix
- Creation and implementation of test plans incl. documentation
- Evaluation and preparation of the validation / qualification report
- Support internal and official audits
Customer benefits
- Audit-proof, validated software solution
- Compliance with all regulatory requirements
- Minimization of failure and product risks
- Approvability of the entire system
- Standard-compliant and safe filling of the active ingredient
Client
Pharmaceutical company - manufacturer of active pharmaceutical ingredients
