Pharmaceutical

Pharmaceutical

Driven by regulatory compliance and having to ship products across the globe, it becomes all the more complex for the pharmaceutical industry to comply with the regulations of various countries. Going digital then is no more a luxury but a de-facto standard for the industry.

QuaLIS® LIMS was originally designed for the pharmaceutical industry, unlike any other generic LIMS. QuaLIS is a powerful enterprise-scale LIMS developed using a strong framework and is fully configurable and customizable for regulated pharmaceutical QA/QC, R&D and analytical development environment.

QuaLIS LIMS covers all the workflow processes within a typical regulated laboratory. It addresses several pain points of the industry and saves >50% of the time and human effort with respect to data capture, review and approvals.

QuaLIS is quite different from the regular LIMS which are generic in nature and require considerable consulting and professional services to meet industry needs. Having been built from scratch, for the pharmaceutical industry, it addresses GLP and 21 CFR Part 11/ EudraLex Annex 11 guidelines. Today, very few LIMS in the international market can match the capabilities of this system.

Human Readable data

Any instrument report is printable in LogiLAB virtual PDF printer. This allows generating electronic human-readable data.

Reports are stored as pdf in a central server, viewable by authorized personnel

QuaLIS® Pharma Highlights

Technology

  • Multi-site and Multi lingual
  • Hosting supported on premise OS (Win/Linux) and Cloud (AWS, Azure, IBM)
  • Runs on any browser like Chrome, Firefox, IE, Safari
  • Tablet supported – iOS and Android
  • Desktop OS supported – Win, Mac, Linux

Technical WorkFlows

  • QC ready – QC/ R&D labs
  • Configurable for Review, approval & release
  • Support Parallel & serial review
  • Support Electronic signature

Others

  • Quality & test planning – bulk/ discrete products
  • Equipment & Instrument Management with Calibration / Validation / Maintenance of records

 

Overview

  1. Multiple types of Sample Registrations
  2. Barcode Labelling
  3. Tests & Specification Management
  4. Work Allocation
  5. Results & Release Management
  6. Reports (COA 2 types + 5 custom)
  7. Instrument Management
  8. Training & Certification
  9. Inventory Management
  10. Document Management
  11. Stability Studies Management
  12. OOS/OOT Management
  13. Deviations/Incidents and CAPA
  14. Method Validation
  15. Environmental Study Management

In Pursuit of Digital Transformation

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