BATCH RECORD MANAGEMENT

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Batch Record Management : The batch record is the KEY measure of the overall organizational efficiency as it reflects any deficiencies in ALL quality systems affecting the overall release cycle time of the manufacturing batch. In Smart-QA we created a module to enhance the ability to track and measure the entire process and to ensure a continuous improvement process is implemented.

Batch Record Management: Smart-QA provides the user with a robust batch record tracking and dozens of key performance indicators associated with turnaround time, right first time documentation, time spent on batch record, efficiency and more.

Smart-QA 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 Batch Record Release 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 reviewers, 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?
The following chart illustrates the process from the beginning with Batch Record issuance (i.e., manually, ERP) and move into received by QA, assignment to a reviewer, initiation of the review, recording of any issues related to documentation errors, pending actions (i.e., investigation, QC samples) all the way to closure of the batch record and recording the KPI such as cycle time, efficiency and right first time documentation.