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
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?