Pharmaceutical and Medical Device

WinLIMS.NET™ includes standard features and controls and functionality to meet the rigorous demands of the world's governments that regulate this business sector. Some of the features that are included within the core and optional WinLIMS.NET™ modules that are specifically designed for the pharmaceutical & medical device business sectors include:

• Electronic signatures in conformance with 21 CFR Part 11
• High levels of role-based security
• Training and qualifications option
• Full trigger-based audit trails
• Version controls for methods, specifications and protocols
• A shelf-life stability management system
• Complaints and corrective actions
• etc.

QSI will provide our internal software validation documentation to you and your validation consultants to assist in your system validation process. Some of our current pharmaceutical and health care customers include:

Watson (Andrx) Pharmaceuticals [1]	Boston Scientific [2]	Morton Grove Pharmaceuticals [3]
Thissen Pharma [4]	Boots Contract Manufacturing [5]	Fleet Laboratories [6]
Jergens [7]	Johnson & Johnson	more...

(the listing of WinLIMS.NET™ customers does not constitute and endorsement of WinLIMS or any QSI products or services)

WinLIMS Features & Options for the Pharmaceutical & Medical Device Industry

Some of the Standard WinLIMS.NET Features that are provided by WinLIMS.NET™ that are traditionally embraced by Pharmaceutical & Medical Device Industry include:

• Role-based Security System
• Version-Controlled Configuration Templates
• Multiple Sample Login Options
• Sample Tracking & Workflow
• Multiple Results Entry Options
• Result, Sample and Product Review
• Powerful Calculation Capabilities
• Document & File Integration
• Instrument Calibration & Maintenance
• On-Line SQC/SPC Charting
• Integrated Reporting
• External Web-Based Reporting
• Inherently Multi-Lingual
• Integrated Audit Trail
• On-Line Documentation & Training Movies
• User-Configurable Data Folders

Optional Modules for the Pharmaceutical & Medical Device Industry

Optional Modules that are specifically designed for Laboratories in the Pharmaceutical & Medical Device Industry include:

• Electronic Signature and Multi-Level Approvals
• Instrument Interfacing
• Shelf-Life Stability
• Protocol-based Testing
• Complaints & Corrective Action
• 3rd Party Integration
• Customer Specification & Product Regrade
• Batch Sequence (QA/QC) Testing
• Document Management
• Materials Management
• Formulation Management & Ingredient Ancestry
• Multi-Site System Segmentation
• External User Access Pages