Business Situation
A major pharmaceutical company had discovered via internal audit, inconsistencies in use of batch record standards in their 12 production facilities. Analysis of the problem pointed to multiple issues in the standards itself and execution of the standards governance policies. The lack of consistent batch records was deemed to have serious compliance and operation risks.
Program Description
The client devised a two part strategy to develop improved batch record standards and to execute a redesign of the existing record based on the new standards. The programs ran in parallel so as to prioritize and address the existing risks as quickly as possible.
Endeavor Involvement
Endeavor was retained in two roles: to provide a series of strategy assessments and recommendations on the harmonization priorities and to establish a program management office to oversee the remediation program. The initial deliverables we focused on root cause analysis of how the problem had developed and the severity of the problem. Compliance issues were identified and immediately addresses while non compliance opportunities were addressed systematically. A long term strategy was developed that provided a evolving standardization process that balanced near term needs as will as a long term goal to achieve ISA S88 standardized batch processing.
Business Benefit
All compliance issues were addressed within 90 days of the project initiation. The new standard was adopted and the roll out project was approved and executed over 18 months. Numerous compliance issues and operational efficiency problems were resolved during the roll out program.
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