Batch Records

Electronic Batch Records are often key to solving issues in the earlier phases of the pharmaceutical development process.  Easy access to process parameters combined with analytical results is a powerful tool to understanding the challenges of your pilot stage manufacture.  Companies rarely implement Batch Records for pilot operations because the combination of flexibility and compliance is difficult to achieve.

SciCord provides a Batch Records solution targeted at pilot scale manufacture.  The solution is designed to adjust to your changing conditions and equipment while retaining the compliance necessary to document production of clinical grade material.  The solution captures process parameters, generates samples for analysis, and then captures both in-process and final analytical results in a structured dataset.

SciCord Batch Records replace the set of spreadsheets often maintained by pilot teams to model their processes.  Capturing data electronically at the source eliminates time consuming and error prone transcription from paper to spreadsheet.

Sharing of samples and results across manufacture teams and analysts facilitates communication and team effort.

Step 1) Define: SciCord provides easy to use tools to define your manufacture process or clone from a previous run.

Step 2) Review and Approve:  Use integral ELN processes to electronically sign for reviews and approval.

Step 3) Execute:

• Automatic generation of batch or lot identifiers while maintaining your current identification format.
• Record references to ingredients and equipment with a single click and automatically populate physical characteristics, safety and hazard information.
• Record weights, volumes, or step completion. Use SciCord’s instrument interfaces to facilitate error free documentation.  Implement step wise execution.
• Electronically sign as operator or witness.
• Define and label in-process samples and final product.
• Flag out of expected operations or results.
• Provide detailed instruction in line with the process.
• Record in-process test results or view lab results in the context of your batch record.
• Completed Batch Records documents are reviewed and approved.

Step 4) Analyze:  Process parameters and analytical results, extracted from batch record documents, are easily accessible using the visualization program of your choice.