Streamline Critical GMP Processes
Gain control over critical GMP processes including vendor management, quality management, and equipment management and stay compliant with ever-changing regulations.
Vendor & Manufacturer Management
- Qualify vendors based on industry protocols
- Enforce ordering from qualified vendors only
- Avoid supply disruptions of raw materials
- Gain visibility into potential risks associated with single sourced GMP materials
- Proactively audit GMP material suppliers to ensure industry standards
- Automatized systematic and periodic recertification of GMP vendors
Raw Materials Labeling, Release, and Quality Inspections
- Ensure compliance by following your organizations SOPs for incoming raw material testing
- Streamline and automatize sampling and testing protocols
- Include incoming raw material testing protocols within master planning
- Perform investigations across multiple people, facilities, and geographic locations
- Ensure sampling rules associated with specific items are followed automatically
- Manage quality testing throughout the materials and production lifecycle
Equipment Management
- Proactively manage equipment maintenance and calibration to reduce the equipment downtime
- Monitor equipment to ensure the proper functioning and usage
- Gain operational responsiveness in case of any equipment deviations
- Use environmental systems tracking, alerts, and insights
- Smart building integration
Bring Your Manufacturing Documentation Under Control. Securely, on Dynamics 365.
Paper records, shared drives, and disconnected document systems aren't just inefficient. They are existential audit risks under FDA and EMA scrutiny. ALCOA+ principles require that every document is attributable, legible, contemporaneous, original, and accurate. Merit's GxP Documents module, built natively on Dynamics 365, gives your quality and manufacturing teams a single, secure, controlled environment for every document that touches your production process.
Use cases include:
- Material testing and inspection documents
- Analytical methods and standards
- Employee training documentation
- Batch production records
- Equipment validation and maintenance records
- Equipment specifications and audit documentation
- Environmental controls logs and history
- Non-conformances, deviations, corrections, and investigation records
- Batch release history
Having the procurement controls and vendor performance insights
provided by Merit for Life Science with D365 allows us to eliminate risk and ensure availability of the raw materials needed to support our manufacturing operations.
[Merit Solutions Customer: Privately held, commercial high growth pharmaceutical manufacturer]
Resources
Procurement Controls Workshop
Attend a free one-day briefing and review your business objectives, discover and visualize solutions, and leave with a clear, actionable picture of how to attain your business goals.
Quality White Paper
Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. See how to unleash a new reality through increased transparency of quality data.
Free Implementation Success Guide
Don’t fail. Learn what it takes prepare for ERP implementation success.