Generate FDA compliant electronic batch records from your Microsoft Word templates. Convert manual paper-based cGMP documents into components of your Electronic Batch Recording (EBR) manufacturing traceability system.
For manufacturers of pharmaceutical drugs and dietary supplements, traceability and control are essential parts of the manufacturing quality system. Compliance with CFR 21 Part 211 or Part 111 requires batch records to document the complete manufacturing history of each batch. Electronic Batch Record systems provide real-time feedback and automated controls to enforce proper documentation. FDA regulated manufacturers who generate and complete batch records electronically must comply with the FDA regulation of CFR 21 part 11 electronic and industry specific cGMP’s.
DataNinja Manufacturing is an easy to implement electronic batch record system for FDA regulated manufacturers who currently generate paper BPR’s (Batch Production Records) using Microsoft Word. Upload your Microsoft Word batch record template into DataNinja for an electronic upgrade. Increase traceability and control in manufacturing without a disruptive implementation that would require rebuilding documentation from scratch. DataNinja Manufacturing allows you to leverage your current investments in documentation without limiting growth due to manual, paper-based BPR’s. DataNinja meets or exceeds all software compliance requirements for CFR 21 part 11.
Simple Implementation – Implement the most important changes and records first. DataNinja Manufacturing is the easiest path to comliant Electronic Batch Records and all the benefits of real-time manufacturing control.
Real-time feedback – Operator feedback the moment data is recorded decreases deviations and reduces quality control response times.
Automated Control – Set targeted metrics and automated escalations if results are outside of limits specified by Quality Control. User permissions determine which employees have authorization to sign-off on any given escalation.
Traceability – DataNinja automatically connects manufacturing interactions in real-time. Effortlessly creating a complete audit trail for optimization analysis.
Electronic Audit Trail – Every edit and entry in the Microsoft Word electronic batch records is marked with a user digital foot print and time-stamp. Better yet, the manual risks of missing paper are avoided.
DataNinja manufacturing with electronic batch records generated from Microsoft Word templates is an ideal solution for Dietary Supplement or Pharmaceutical manufacturers who demand increased traceability and quality control. A few features are highlighted below:
Barcode verification – scan a barcode instead of writing a lot number, DataNinja checks and verifies that material is released and non-expired, not to mention the right part and concentration.
Electronic Signatures and initials– Use a tablet and stylus or your finger for initials and bi-factor authentication for CFR 21 part 11 electronic signatures.
Trackable attributes – Set tracking attributes on data entry fields to monitor for user entered data to meet specification thresholds or data formats. Set required fields that will prevent batch approval if not completed as required.
Tiered approvals– When your batch record approval is complete the electronic batch record is automatically queued in the next persons’ approval dashboard. Automatic routing with DataNinja provides more efficient batch release workflows for Microsoft Word electronic batch records.
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