D365QCS

D365QCS™ offers a robust ERP solution tailored for the pharmaceutical and life sciences industry, ensuring compliance with FDA, Health Canada, and EU regulations. This software, integrated with Microsoft D365, addresses complex global regulatory and quality standards.

It aids life sciences companies in optimizing their supply chains, meeting business standards, enhancing forecast accuracy, and driving operational efficiency while adhering to Good Manufacturing Practices (GMP) including DSCSA support.

Advanced Capabilities

• CAPA Management: Efficiently control non-conformances and deviations with corrective and preventative actions online.
• Electronic Batch Records: Capture complete manufacturing and environmental details from raw materials through to final packaging, including e-signatures for authenticity.
• Recall Management: Efficiently handle recalls across product lines with thorough traceability.
• Enhanced eSignature: Ensure security and authorization across multiple production and quality control sign-off points.
• Computer System Validation (CSV): Provides on-site validation packages and compliance support tailored to unique client requirements.
• Deviation Control: Incorporates sample management, environmental monitoring, and regulatory quality reporting.
• Sample Management: Facilitates seamless communication between the laboratory and enterprise systems.
• Environmental Monitoring: Manage environmental conditions to meet compliance needs.
• Regulatory & Quality Reporting: Generate documents necessary for industry compliance.

This ERP solution uniquely positions life sciences companies to stay compliant and competitive by driving change and maintaining adherence to industry standards.