Life-sciences & Biotech

Life-sciences & Biotech

The life sciences industry is moving toward a customized solution for individual patients using advanced biotechnology. The quality, integrity and volume of results are increasing every day making data integrity indispensable. Going digital for life sciences is a natural choice as such the volume and complexity of data generated is humanly impossible to be handled by manual systems.

QuaLIS® LIMS, though originally designed for the pharmaceutical industry, was enhanced with advanced process workflow (sample processing, Assay/ Test) capabilities specifically for bio-pharma, clinical research etc. QuaLIS, being an enterprise scale LIMS, has been built on a strong framework along with a fully configurable workflow engine for regulated life sciences QA/ QC, R&D and can hence go a long way in this industry vertical.

QuaLIS LIMS covers all the workflow processes within a typical life sciences 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, which is still happening in disparate systems such as Microsoft Excel.

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

QuaLIS® Life Sciences & Biotech Highlights

Technology

  • Multi-site and Multilingual
  • 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 are

  • QC ready – QC/ R&D labs
  • Configurable workflows for batch sample processing
  • Single vial to multi-vial to plates management
  • Configurable workflows for assays
  • Configurable for Review, approval & release
  • Supports Parallel & serial review

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. Multiple types of Sample Registrations
  14. Project Management
  15. Sample processing workflows
  16. Assay/ Test workflows
  17. Bulk Barcode Label Module
  18. Tests & Specification Management
  19. Work Allocation
  20. Results & Release Management
  21. Reports
  22. Instrument Management
  23. Training & Certification
  24. Inventory Management
  25. Document Management
  26. Stability Studies Management
  27. OOS/ OOT Management
  28. Deviations/Incidents and CAPA
  29. Method Validation
  30. Environmental Study Management

In Pursuit of Digital Transformation