Software Solution to manage lifecycle management of BMR/BPR master formats or templates. Architecture allows application access using web technology . Can be scalable to manage documents across geo locations. Electronic Signatures and audit trails as per 21 CFR Part 11 guidelines of USFDA. Configurable workflow for documents as per user requirement. Auto task reminders through emails and notifications. Issuance of batch cards with auto calculation of raw material values based on input batch size. Option to have computer generated Batch card number or to give it manually. Controlled printing of Batch cards. Batch card issue register.

Key Features:

  • Uses latest version of Batch Master Record template for Issuance
  • Well documented Process of Batch card request by Production Planning all the way to relevant Batch Card Printing
  • Part 11 Compliance
  • Automated Calculation of BOM based on pre-defined formulae and required batch size. Eliminates manual efforts to ensure correct BOM quantities.
  • Review Approve Process for final Batch card issuance
  • Printing approval by QA department
  • Re-issuance with proper QA approvals and Control
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