Procedural aspects
Procedural aspects, from project planning to compliance
Project planning and execution according to GAMP5
When planning and executing a software implementation project in a regulated environment many aspects should be defined before you start. Among many other things...
...your validation plan, user requirements and functional design specifications have to be prepared, IQ, OQ and PQ plans need to be written and the corresponding tests need to be carried out being thoroughly documented and approved by your QA at the end. Before you actually decide to go with a specific vendor, you may also want to audit him. Vialis has the expertise to plan and run your projects according to GAMP4 guidelines, making sure that nothing gets forgotten and that the correct sequence is being followed. We support you from the preparation of the first documents to final approval by your QA, of course also taking your internal procedures into account.
Life-cycle management
Once your system is up and running you need to make sure, that you have procedures in place that keep it qualified for its use. Maintenance, improvements and...
...and adoptions to your organisational changes need to be carried out according to strict change management procedures. Vialis will help you establishing these procedures, carrying out testing and qualification of changes, keeping your system in excellent and qualified condition. Vialis may even run your functional help-desk for you, providing first class support for your users.