Risk-based validation of computer systems in regulated environments
Valicare supports you implementing the requirements for computer system validation (CSV) in GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and for medical devices.
Essential regulatory requirements for respective areas of interest are listed below.
Basic requirements differ only in details, but those details cause issues in inspections. In the area of GLP, there is for example the requirement in various countries that source codes must be available in the test facility or can be obtained timely. In the GMP-regulated environment, however, this requirement does not exist.
In GCP, GMP and GDP, the guide "Good Automated Manufacturing Practice 5" (GAMP 5) of the International Society for Pharmaceutical Engineering (ISPE) has prevailed as a guideline for practical implementation. Depending on the complexity and criticality of the system, individual checks which are typically part of an entire validation can be risk-based assessed and omitted.
Valicare supports you intensively in the implementation of CSV requirements. Our expertise is based on many years of successful implementation of GxP-CSV projects (incl. medical devices). We have ready and proven concepts and work instructions for CSV for both existing and new systems. We apply the industry standard to validate the systems comprehensively.
According to your company guidelines, validation can also be referred to as qualification and verification. Hardware and software are included and, according to a preceding risk assessment, the operating environments, networks and databases if necessary. The entire product life cycle is considered on a risk basis, from planning to decommissioning.
Project consulting often starts with recording of the current state, including the distribution of roles. Especially in the area of CSV, several groups of people are often involved, such as IT, quality assurance, users, and the validation team. Usually in a first step, the roles must be defined and distinguished from the individual areas, and the requirements and responsibilities for validation have to be coordinated. An external consultant, who knows the different perspectives of the validation process, is very helpful here.
Examples of our services are:
- Project management
- Preparation and review of the validation master plan
- Preparation and review of the basic documents for planning and implementation and
- for commissioning and decommissioning of hardware and software
- Preparation of validation plans and validation reports
- Execution of risk analyses and generation/review of the traceability matrix
- Definition and preparation of test cases
- “Hands on" implementation of the validation
- Validation of excel spreadsheets
- Validation of computer-aided laboratory systems
Our services are based on your requirements. We offer the desired validation, from pure consulting to processing of individual subareas to complete implementation including documentation.