Pharmaceutical QA/QC

Pharma being a regulated industry, implementing a LIMS solution has always been a challenge.QuaLIS Pharma has been designed to handle pharmaceutical QC/QA operations of both API (Active Pharmaceutical Ingredients) and formulations. The system has all the necessary features to handle compliance with respect to GLP, 21 CFR Part 11 and other international guidelines.

QuaLIS pharma has various modules that help in complete management of the regulated pharma QC/QA.

• Sample Registration
• Barcode Labelling
• Job Allocation
• Test Masters
• Test Group & Specifications Masters
• Results Entry (Manual)
• Advanced Test Data Sheet Automation with Instrument Interfacing (LogiLab)
• Document Management(SOP Management)
• Materials Management(Reagents, Standards (Working,reference)
• Log Books
• Column Management
• Training Record Management
• Instrument /Equipment Management
• OOS- Investigations
• OOT- Investigations
• Approval and Release
• Reports
• Deviations Recording
• Change Control Management

QuaLIS pharma will provide a quick start for any pharmaceutical laboratory. It is possible to implement QuaLIS Pharma in a much shorter timeline. Our professional services team can offer validation services and provide you a turn-key services to implement a fully validated solution.

End Users

Pharmaceutical industries involved in active pharmaceutical ingredients (API) and finished dosage forms, USFDA,MHRA and any other internationally accredited laboratory who are