Manage Quality From ERP
D365 QCS™ is a Quality and Compliance software solution built for Microsoft Dynamics ERP. It enhances standard ERP and bridges the requirements gap and design elements that are missing in standard Microsoft Dynamics ERP and are specifically required for life sciences quality compliance. D365 QCS™ combined with Microsoft Dynamics is a complete ERP solution to serve the complex global regulatory compliance and quality management requirements of Life Sciences companies.
Integrating multiple software solutions creates information silos that blocks effective communication. That’s why D365 QCS™ was built on Microsoft Dynamics ERP. Microsoft Dynamics is a Tier one enterprise resource planning solution with industry capabilities for Life Science.
Eliminate Bottlenecks: comprehensive features of Dynamics 365 eliminate information bottlenecks by leveraging system wide business data
Enhance your Investment in ERP: Dynamics 365 combined with D365 QCS™ delivers an upgraded and fully integrated solution that serves the complex requirements of Life Science companies. It streamlines production and quality management to ensure compliance with global GxP regulations, FDA 21 Code of Federal Regulations (CFR) Part 11, Health Canada and EU Compliance requirements.
Manage Non-Conformances & Deviations with on-line Corrective Actions & Preventative Actions
Electronic Batch Records
Capture manufacturing & environmental details from raw material / components thru to finished packaging complete with e-signatures
Most effective management of recalls for multiple products with complete traceability
Authorize and maintain security at multiple sign-off points necessary in Production & Quality Control
Computer System Validation (CSV)
Validation package with verification on-site. Regulatory and compliance support for requirements not yet included or unique to client
In process control of master formula
Easy communication from the lab to your enterprise system
Regulatory & Quality Reporting
Industry compliance documents
Production control of products for compliance
D365 QCS™ Advantages
Designed and developed by regulatory and compliance experts with prior GxPs implementation, auditing and validation experience globally.
- Validated solution that saves in costs of separate validation efforts with multiple partners
- Centralized data and processes within ERP eliminates the need for multiple software