Establishing a Data Integrity Governance Program for a Biotech Company
Clarkston Consulting partnered with a biotechnology company to enhance their data integrity governance, addressing significant challenges and ensuring compliance with industry standards. Read a synopsis of the project below or download the full case study.
Download the Data Integrity Governance Case Study Here
Clarkston was identified as a key partner to support the client, rapidly establishing a comprehensive data integrity policy aligned with the latest regulatory requirements for data integrity governance. This policy provided clear guidelines for managing and safeguarding data throughout its lifecycle, including expectations for data management, validation, and audit trails to maintain accurate and complete records.
Clarkston carried through that support to design a targeted remediation strategy to align with the new policy. This involved assessing existing practices to identify vulnerabilities and compliance gaps and developing an understanding of the client’s capacity to achieve significant transformation. The effort was broad and consisted of evaluation and remediation across computerized analytical instruments, audit trail review, data integrity assessments, training, inspection readiness, and governance strategy. Clarkston also monitored and reported to leadership on the effectiveness of actions taken over several months.
Introducing new, risk-based strategies for data integrity was critical for the client. Clarkston worked with the client to tailor an approach that satisfied regulatory requirements and aligned with existing computer system validation and risk management practices. This approach provided evidence that allowed the client to focus resources and efforts based on the risk associated with different data processes. This risk-based methodology enabled the client to concentrate on the most critical areas, optimizing resource allocation and improving overall data governance.
As a result, the client now benefits from a more robust and resilient data integrity framework. There is an appreciation across the organization for the improved data accuracy, reduced risk of compliance issues, and a stronger data management system. This strategic change not only ensured regulatory compliance but also positioned the client for sustained success in their competitive industry.
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Contributions by Jonathan Benincosa
