InstantGMP

This feature provides 21 CFR part 11 compliant electronic batch records (EBR), digitizing master production records and batch production records. It replaces error-prone paper and spreadsheet-based systems, streamlining documentation. InstantGMP allows for faster version control, scale-up, and editing of master records, significantly reducing chances of manufacturing errors and ensuring full regulatory adherence.

The software’s inventory management complies with Part 11 electronic signatures for all inventory, room, and equipment logs. This module controls real-time, precise tracking of material movement, including raw materials and finished goods. Users can seamlessly integrate this with material planning to ensure timely availability of necessary components for production runs.

Users can utilize this log to maintain comprehensive digital records for all manufacturing equipment and instrumentation. This feature tracks critical information, including calibration schedules, maintenance history, and usage logs. The system ensures that all equipment is validated and compliant before being used in a batch, supporting accurate audit trails and minimizing risk.

InstantGMP incorporates a report tool that allows users to quickly generate essential documentation across all system modules. This includes quality records, batch summaries, and inventory usage reports for audit preparation. The platform uses this functionality to transform process data into actionable metrics, enabling data-driven decision-making and continuous improvements in manufacturing efficiency.

This feature provides users with the flexibility to customize forms and records by adding new, essential data fields. Dynamic Fields enable the capture of unique information specific to custom processes or new product manufacturing. The software maintains GMP compliance by ensuring all user-defined fields are tracked and validated within the overall document and quality management framework.