Merit for Business Central

Merit for Business Central is a suite of compliance and regulatory applications built to work seamlessly with Microsoft Dynamics 365 Business Central. Designed for regulated industries including Life Sciences and Food & Beverage, it delivers the critical capabilities businesses need to meet stringent quality and compliance requirements without leaving their ERP environment.

The suite comprises four core modules — Audit Trails and Electronic Signatures, Quality Inspections, Vendor Compliance, and Quality Management — each addressing a distinct area of regulatory and operational compliance. All modules are available for purchase directly on Microsoft AppSource.

Audit Trails and Electronic Signatures

• Complete Audit Trails: Maintain a detailed, auditable history of changes to critical data and processes, with the ability to generate detailed, customizable reports for seamless audits.
• Flexible Audit Logic Engine: Tailor audit logic to any data set to meet the specific requirements of your auditors and regulatory environment.
• Electronic Signatures: Sign all data changes with flexible authorization controls, ensuring digital records are reliable and compliant.
• FDA 21 CFR Part 11 & EU GMP Annex 11 Compliance: Meet stringent regulatory requirements through electronic signatures and detailed audit trail reporting.

Quality Inspections

• Customizable Quality Plans: Define product quality standards using structured criteria and requirements tailored to your organization.
• Flexible Sampling Rules: Tailor sampling approaches based on product criticality, past performance, and applicable regulations.
• Flexible Sampling Frequency: Optimize quality and compliance by adjusting inspection frequency based on relevant factors.
• Quality Controlled Inventory Lots: Ensure only products that meet quality standards are distributed, maintaining customer satisfaction and compliance.
• Comprehensive Certificate of Analysis: Provide customers and regulators with assurance of product quality and safety.

Vendor Compliance

• Vendor Qualification: Extensive capabilities for vendor certification and classification, with streamlined approval processes to ensure high standards are maintained across the supply chain.
• Risk Assessment: Gain insights into potential risks associated with single-sourced GMP materials to proactively manage supply chain vulnerabilities.
• Supply Chain Efficiency: Restrict ordering to qualified vendors to avoid disruptions to the supply of raw materials.

Quality Management

• Comprehensive Incident Tracking: Manage every type of quality event, including nonconformances (NCRs), corrective and preventive actions (CAPAs), deviations, complaints, and audits.
• Event Category Assignment: Automatically assign categories to each quality event, ensuring the appropriate quality processes are initiated based on event type.
• Structured Quality Processes: Follow a step-by-step process for each quality event, ensuring compliance with regulatory requirements and company SOPs.
• Automated Event Creation: Configure automated triggers for quality events based on pre-defined rules such as production failures or inspection rejections, enabling swift issue identification and action.

Merit for Business Central modules and industry solutions are available on Microsoft AppSource. Merit Solutions also offers direct expert consultation and support resources to help organizations implement and maximize the value of each module within their regulated environment.