Challenge: An international pharmaceutical corporation engaged Beaufort to assess the entire validation process for a recently acquired global business unit.

Beaufort Solution: The acquired global business unit had a validation process that was different and did not meet the global validation requirements of the parent corporation. We performed a “deep dive” assessment of its validation process: from the technical and compliance assessment of the original validations, through its current process and approach, to the gap analysis for implementing a new validation process that met all the requirements of the new parent corporation.

The assessment confirmed that there was an opportunity to create a competitive advantage by minimizing compliance risks and improving operational performance of the new business unit by the implementation of a new validation process designed according to the latest industry standards that meets all requirements of the parent corporation. The Beaufort QA team, working side by side with its validation, quality, and engineering teams, developed the new Validation Master Plan, updated all of the documentation, facilitated the required training, and identified all the implementation mechanisms for ensuring a successful integration of the new validation system and the execution of the required re-validations at the newly acquired business unit.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance