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Batch Record Release Process Challenges

 

cME can address the following challenges:

§         What is the Right First Time (by area / product)?

§         What is the QA review cycle time?

§         What is the Mfg./Pkg. response time to correct documentation errors?

§         What are the main delays / pending issues causing BR delays?

§         What is the impact of investigations / CAPA closure on the BR release time?

§         What is my reviewer’s efficiency?

§         What is the RFT by QA tech, and what leads to the variability between QA techs?

§         What are the causes for time losses for my reviewers?

§         What are the value added reviews / stages throughout the release process?

§         What is the breakdown of the documentation errors?

 

Batch record is one of the most significant contributors to cycle time and typically accounts for a third of the overall cycle time.

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