Developing a GMP Data Integrity Training Program for a Biotech Company
Clarkston Consulting partnered with a biotechnology company to develop a comprehensive GMP data integrity training program. Read a synopsis of the project below or download the full case study.
Download the GMP Data Integrity Training Program Case Study Here
A GMP data integrity training program, consisting of 20 courses that cover fundamental to advanced concepts, was designed to enhance employees’ knowledge and ensure compliance with industry regulations as part of a robust data governance framework. The training program was a critical component of a broader data integrity initiative aimed at addressing key challenges in data management, validation, and audit readiness.
Clarkston helped the client develop a structured data integrity training plan that aligned with regulatory requirements and organizational needs. The program included courses progressing from foundational principles, advanced data lifecycle concepts, and management and culture, to courses addressing specific concerns in targeted areas.
The curricula covered critical areas like data governance, validation practices, audit trails, risk-based compliance strategies, and data lifecycle controls. Each course was designed with clear objectives to enhance employees’ understanding of data integrity best practices, regulatory expectations, and their roles in maintaining compliance. The training plan also outlined the relative timing of courses, ensuring a logical progression from introductory topics to more complex compliance and governance strategies, allowing employees to build their knowledge systematically and apply key concepts effectively in their daily operations.
The training program emphasized pragmatic, real-world solutions to data integrity challenges. Courses incorporated a combination of situational-based exercises, case studies, and interactive workshops to help employees apply data integrity principles in their daily workflows. Training modules addressed common compliance pitfalls via a risk-based approach providing scenarios that mirrored real regulatory challenges. By integrating practical applications into the curriculum, the program ensured that employees not only understood theoretical concepts but could also implement best practices effectively, strengthening overall data governance and compliance readiness.
As a result, the organization now benefits from a stronger data integrity framework, reduced compliance risks, and improved data accuracy. This initiative not only ensured regulatory adherence but also positioned the company for long-term success in a competitive industry.
