Computer System Validation
To ensure compliance with regulatory and industry requirements, it is essential that computerised systems utilised in manufacturing and laboratory environments are qualified and validated. Computerised systems encompass workstations, instrument software, equipment software, networks (wired and wireless), operating systems software, application software and interfaces with other computerised systems.
Autocal Ireland offer complete validation services in the following areas:
- Development of validation master plans
- Gap analysis of existing in-place systems
Preparation of Software validation documents:
- User requirement specifications
- Functional detailed descriptions
- Software Requirement Specifications
- Traceability Analysis
- IQ/OQ/PQ documents
- Risk assessment
- Development of all relevant SOP's
- 21 CFR Gap analysis, remediation and validation
Contact us here for further information.