Maintain Control of Manufacturing Processes
Merit for Life Science with Microsoft Dynamics 365 facilitates planning, execution, monitoring, tracking, record-keeping, and documenting of manufacturing processes for biotech, pharma, and medical device organizations.
Weighing and Dispensing
.
Control processes when measuring or transferring materials.
Quality Orders
Meet FDA compliance standards on your production floor.
Electronic Reporting
.
Electronic batch report or electronic device history report in a single document.
Finished Product Management
.
Finished product quality testing, approval and release, and more.
Digital Collaboration
Secure platform for controlled document exchange.
Weighing and Dispensing
Follow strictly controlled processes when measuring or transferring materials between containers to avoid damage, contamination, and corruption.
- Ensure compliance with the tightly controlled environmental factors
- Leverage quality checks both before and after the dispensing process takes place
- Gain a clear, transparent, and rigorous audit trail behind what was done, when, and by whom
- Apply multi-person electronic signatures as required
- View a complete audit trail behind the equipment used, the dispensing room environment, and personnel action, reinforced with dual electronic signatures
- Easily manage and streamline sensitive measurement processes
- Ensure the measured quantity is always within the designated tolerances
Quality Orders
Collect process measurements and quality metrics required for a proper audit trail of the production process.
- Ensure compliance with industry regulations by providing documentation and being always audit-ready
- Improve product quality and meet desired standards, minimizing defects and rework
- Reduces costs associated with rework, scrap, and warranty claims by identifying and addressing quality issues early
- Enhance visibility and traceability into the production process, enabling timely identification of quality issues and preventing recalls
- Gain data-driven decision-making and process optimization for ongoing quality improvement
- Enable quick identification and resolution of quality issues, minimizing disruptions to production
- Reduces the risk of product recalls, 483 letters, and non-compliance penalties
- Leverage valuable insights into production trends, enabling proactive quality management strategies
Electronic Reporting (EBR and eDHR)
Assemble an electronic batch report or electronic device history report into a single document.
- Consolidate manufacturing records and audit trails for a specific production batch to help expedite its approval and release
- Initiate, prepare, and produce EBR (Electronic Batch Records) or eDHR (Electronic Device History Records) with a single touch of a button by leveraging the power of all the different integrated processes within the Merit for Life Science ERP platform
Finished Product Testing, Release,
and Labeling
Efficiently manage stringent regulations for finished product quality testing, approval and release, as well as labels documentation and record keeping.
- Ensure compliance by following your organizations SOPs for finished product testing
- Automated and streamlined sampling and testing protocols
- Finished product testing protocols included in the master planning
- Investigations can be performed 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
Merit for Life Science with D365 allows me to manage precise dispensing,
quality acceptance, and reporting related to production while working digitally
with CDMO and CRO partners.
[Merit Solutions Customer: Privately held, pre-commercial cell and gene therapy manufacturer]
GxP Documents
Fundamentally improve the quality and security of your inventory and warehouse documentation. Use cases include:
- Material inspection records
- Material COAs
- Material specifications
- Batch track and trace records
- Dispensing records
- Shipping records
- Material receipt records
- Batch Release history
Resources
FREE Production 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 an FDA-ready manufacturing future.
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.