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Electronic Batch Records

Easy to Create, Easy to Follow Production Records

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InstantGMP Electronic Batch Record

Creates and maintains electronic batch records with version control, scalability, and traceability to promote compliance and efficiency.

  • Tracks inventory and materials used in production, ensuring that correct quantities are used and recorded.
  • Assists in ensuring that all manufacturing processes adhere to regulatory requirements for Good Manufacturing Practices (GMP).
  • Includes electronic signature capabilities to ensure the authenticity and security of reviews and approvals.
  • Maintains a comprehensive audit trail, recording all actions and changes made within the system per 21 CFR Part 11 requirements
  • Provides one-click access to Equipment Logs, Room Logs, Inventory, and verification for completion of required entries during batch production.

Parallel or Sequential Processing

  • Tabbed format provides easy access to all workflow steps
  • User-controlled fields (Dynamic Fields) created and configured at each step record current data connected from previous steps
  • Formulas can be programmed to perform calculations and comparisons with previous dynamic fields at any step in the batch record
  • Operational costs and pricing captured in real-time
  • Scale up/down function creates new master records when yield change is required and automatically revises the bill of material amounts
  • One-click versioning makes changes to Master Production Records simple and fast
  • Customizable to each client’s unique procedure for their electronic batch records

Seamless Workflows in a Single Integrated System

    • Enforces collections of information and data that contain all the information required by GMPs
    • Cover page summarizes details including name, strength, and expected yield
    • Bill of materials shows weight or measure of each component to be used
    • Lists equipment to be used in the manufacturing process
    • Allows documents, pictures, and videos to be attached at each step
    • Contains list of in-process testing to be completed
    • Links electronic logs to production records make cleaning and use entries straightforward to complete and easy to verify in real-time
    • Permits each step to easily customizable for signature requirements and equipment or room use
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Tracking for All Material Usage

  • Automatically Recorded

    Each individual step and updated in inventory, including the history of all materials used

  • Receipts

    Unique material receipt, batch, and production numbers

  • Tracked

    Track when a product is planned for production and when a product was actually produced

  • Raw Materials

    Quantities of raw materials and ingredients that went into a batch and which lots of raw materials and ingredients were used

  • Resolutions

    Any deviations that were investigated and resolved

  • Time Stamped

    Electronic time-stamped signatures of performers, reviewers, and quality

Learn More about our InstantGMP PRO System

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All InstantGMP Features

InstantGMP simplifies the documentation and approval procedures for quality processes. It provides inventory control, streamlines production, and elevates the overall quality of finished products while ensuring unwavering GMP compliance.

Electronic Batch Records​ Inventory Management​ Quality Management​ Document Management​ Equipment Log​ Learning Management​ AI Insights Bar Code Scanning​ Split Lot Receipts​ Pick List​ Scale Integrations​ API Specifications​ Vendor Management​ Room Logs​ Dynamic Fields

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