Make the most of your investment in BIOVIA solutions with lab-to-plant process consulting, onsite implementation, expert training and superior support

Project Planning and Lead

Project Planning and Execution According to GAMP5

Planning and executing a software implementation project in a regulated environment requires the preparation of a validation plan, user requirements and functional design specifications. In addition, Installation Qualification, Operational Qualification and Performance Qualification plans have to be prepared, and corresponding tests have to be carried out, thoroughly documented and approved by the customer’s QA organization.

The BIOVIA Management Consulting group is experienced in orchestrating and leading projects with the involvement of several vendors ensuring optimal coordination and smooth handover of tasks between the different parties. These can comprise software application vendors, technology providers as well as instrument manufacturers and customer project team members.

BIOVIA Management Consulting offers the expertise to plan and run software implementation projects for customers in compliance with GAMP5 guidelines. We support you from the preparation of the first documents to final approval by your QA, taking your internal procedures into account and ensuring that nothing is left out and that the correct sequence is followed.

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