High-level, systematic and documented planning forms an important basis for a risk-based and therefore efficient execution of validation activities. A validation master plan (VMP) clearly lists all the individual steps. Computer-aided systems must be considered here as well. They are either addressed in a dedicated section of the general VMP or in a separate VMP IT.
Establishing an Overview – the Inventory list of Computer-aided Systems
An inventory list of all computer-aided systems in the area of the company under consideration is prepared with the help of an Excel® template proven in numerous projects. System information is recorded by taking an inventory on site and/or using information provided by the customer. By request gempex provides the inventory list with cell protection, input validation and an integrated audit trail function. This enables GMP-compliant data maintenance. Elaborate version management for the inventory list is eliminated.
Identifying GMP-critical Systems with Certainty
The risk classification of all systems recorded in the inventory list is performed in a second phase. This encompasses the following four sub-steps:
- determining GMP relevance
- determining GMP criticality
- categorising the IT components (hardware/software) of the computer-aided systems according to the GMP guideline
- determining relevance for electronic records and signatures
The specific evaluation results are determined directly in the inventory list by answering the corresponding questions. Thus, preparing separate checklists is not necessary. The basis for decision making is always transparent and comprehensible.
Risk-based Planning of Validation Projects with Focused Effort
Also within the inventory list, the resulting validation projects are prioritised jointly with the customer in a final step and a preliminary schedule is developed on this basis. Planning is therefore linked directly to system evaluation and clearly comprehensible.
For integration into the higher-level GMP quality assurance system, gempex prepares a separate VMP IT based on a document template developed in-house or adds the relevant content to an existing general VMP of the customer. The following points are addressed among others:
- regulatory basis
- organisational structure in the field of application
- responsibility for and organisation of validation for computer-aided systems
- risk classification procedure
- fundamental approach to the validation of computer-aided systems
- clear overview of all systems requiring validation and their GMP criticality
- clear guideline for the next steps
- compliant basis for the validation of computer-aided systems
- efficiency through the use of gempex in-house templates
- many years of IT and GMP expertise