Computerized systems for GxP related processes (manufacturing, warehouse, distribution and quality control) may impact on product quality, data integrity and patient safety. Therefore, GxP relevance of a Customer Service must be assessed and it must be managed in the framework of a life cycle management according to GMP, Annex 11 (Computerized Systems) and 21 CFR Part 11 (electronic records).
The activities covered by Promeridian during the system life cycle are Customer Services validation according to the V-model of GAMP 5 (A Risk-based Approach to Compliant GxP Computerized Systems): planning, specification, configuration, verification and reporting. Other activities which will be covered are IT infrastructure qualification, periodic review, retirement and decommissioning. The Computer System Validation experts of Telstar are also providing support for system inventory or a Validation Master Plan with risk or criticality rating, validation status and frequency.
At the planning stage, risk assessment will be performed by Promeridian in order to ensure product quality, data integrity and patient safety. Software and hardware is categorized according to GAMP 5 categories. Related to the category, the validation strategy will be defined, requiring more extensive for higher categories and reduced validation tests for lower ones.
At the specification stage design specifications will be developed, at the verification stage the test protocol is executed and at the reporting stage the results are summarized.
Promeridian can cover the following activities:
- Computerized system validation of medical devices
- Control systems (SCADA, BMS, etc.)
- Laboratory systems (stand-alone & networked)
- Management systems (ERP, LIMS, document management systems, CAPA systems, etc.)
- Warehouse management systems
- Policies and SOP advice / implementation, GxP compliance advice (21 CFR part 11, Annex 11, GMP)
- Data integrity process
- Integral validation of serialization systems
