Merit for Business Central
Life Science
Streamline Your Life Science Operations
Merit for Business Central
Life Science
Streamline Your Life Science Operations

Advanced Features for Dynamics 365 Business Central
Comprehensive Quality Management for Life Science
with Microsoft D365 Business Central
Audit Trails and Electronic Signatures
Ensures full compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 by providing secure, traceable digital records. The Audit Trails feature tracks data changes across your system, ensuring that every action is logged, accounted for and auditable. With Electronic Signatures, users can approve data modifications using unique password-protected signatures, with reason codes and comments required for compliance.
- Compliance: Meets key regulatory requirements for electronic records and audit trails.
- Efficiency: Streamlines audits and reporting, reducing manual paperwork and potential errors.
- System Confidence: Maintains security and traceability, ensuring audit-readiness with “ready-to-print” reports.
Quality Inspections
Automates the quality control processes, ensuring product safety and regulatory compliance. With Customizable Quality Plans, companies can define product-specific quality standards, while flexible sampling rules and frequencies allow for adjustments and customizations based on product criticality and performance history.
- Comprehensive Testing: Inspects raw materials, in-process, and finished products.
- Quality Control: Ensures only compliant products enter the market through quality controlled inventory lots.
- Certificates of Analysis: Provides comprehensive quality documentation for customer and regulatory confidence.
Vendor Compliance
Vendor approval, qualification, and management are automated to prevent potential supply chain disruptions. Vendor Qualification ensures that all suppliers meet stringent regulatory standards, while Risk Assessment identifies potential vulnerabilities in the supply chain associated with single-sourced GMP materials.
- Enhanced Compliance: Maintains high standards with robust vendor qualification and certification.
- Risk Mitigation: Monitors vendor certifications and classifications to proactively reduce risks.
- Safety and Quality: Simplifies vendor management ensuring orders from qualified vendors only.
- Structured Process: Automates tracking and resolution for incidents like deviations, CAPAs, NCRs, complaints, and audits.
- Compliance: Supports adherence to internal quality SOPs and regulatory requirements.
- Incident Prioritization: Provides transparency and ensures that critical issues are addressed promptly.
benefits
Streamline Life Science Operations, ensure compliance, and reduce risk.

Efficiency Gains
Automates and streamlines compliance processes for enhanced supply chain reliability and faster issue resolution.

Risk Reduction
Manages vendor qualifications and approvals and quality issues proactively, maintaining product quality while minimizing operational disruptions.

Regulatory Compliance
Helps life science manufacturers meet FDA, GMP, and other global regulatory standards.

Enhanced Traceability
Tracks every change, creating auditable record from raw materials to finished good, ensuring full visibility throughout the supply chain.
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Buy Merit Business Central - Life Science on AppSource!
Give Merit for Business Central Life Science a try. Available on Microsoft AppSource today.
Talk to an Expert
Contact Merit for Business Central Partner, RSM, for more information about our products.
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