Global Batch Record Harmonization
Solution

Endeavor was retained to provide assistance on multiple levels. First, to provide a series of strategic assessments and recommendations on the harmonization priorities. Second, to establish a program management office to oversee the remediation program.

 

The initial deliverables Endeavor focused on also involved a root cause analysis of how the problem had developed in the first place, and how severe it was. Compliance issues were identified and immediately addressed, while noncompliance opportunities were addressed more systematically.

 

Endeavor developed a strategy for the client that provided an evolving standardization process, which balanced near-term needs as well as a key long-term goal — to achieve ISA S88 standardized batch processing.

Benefit

With Endeavor’s help the client was able to address all compliance issues within 90 days of the project initiation. The new standard was adopted across the company, and the roll out project was approved and executed over the following 18 months. Numerous compliance issues and operational efficiency problems were resolved based on this new system.

Problem

After performing an internal audit, a major pharmaceutical company discovered inconsistencies in the use of batch record standards in their twelve production facilities. Further analysis pointed to multiple issues in the standards themselves, in addition to execution of their governance policies. This lack of consistent batch records was deemed to be a serious compliance and operations risk.

 

The client devised a two-part strategy: to develop improved batch record standards and to bring the existing records up to the new standard. The programs ran in parallel so as to prioritize and address the existing risks as quickly as possible.

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