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Batch Record Review Experts Support Product Development

 

INDUSTRY

Pharmaceutical

SERVICES

Quality Assurance
Remediation

SKILLS

Empower V2
Eight Analytical Data Reviewers and Batch Record Reviewers to inspect six months of batch records.

The Challenge

A research-based biopharmaceutical company was in the midst of a large data review when they discovered the newly-implemented system had not been properly collecting the necessary data. After some investigation, the client determined that the accurate data they had from six months of product development was limited. Although they originally planned to place individuals from their internal analytical teams on the project, they found it detracted from their product development, so they decided to seek external assistance.

The Solution

The Oxford team took the time to listen to the client’s requirements and quickly identify resources. Within a five-minute conversation, our team produced a viable candidate option that fit the job description. Due to Oxford’s unique ability to quickly provide resources with the necessary experience within batch record review, analytics, and Empower V2, the client decided to partner with us. Over the course of the project, we provided a total of eight Analytical Data Reviewers and Batch Record Reviewers to carefully inspect six months of batch records and cross reference them against previous record sheets to locate gaps and designate them for remediation.

The Result

Although the client initially expected the project to take two months, the scope expanded, and Oxford was able to provide additional resources to support the initiative and complete the data review within six months. Because of the assistance they received, the client was able to correct the issues within the new system and maintain production with no interruptions.