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

Maintain regulatory compliance with secure digital records

Quality Inspections

Streamline quality control to support safety and compliance

Vendor Compliance

Optimize vendor management for quality, compliance, and safety

Go to Quality Management

Quality Management

Simplify incident management to enable quick, compliant resolution

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.
Electronic signature settings

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.
Screenshot showing how you can assign classifications within Merit for Business Central Vendor Compliance

Quality Management

Manages incidents such as nonconformances (NCRs), corrective actions and preventive actions (CAPAs), deviations, audits, and complaints, aligning with regulatory standards and internal SOPs. The system automates incident creation based on triggers like production failures or inspection rejections, helping to resolve issues quickly.

  • 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.

Ready to take the next step?

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.

Get Answers

Visit our Help page for answers to common questions and additional resources.