Merit for Regulated Industries
Cloud-first ERP for organizations with strict compliance and oversight requirements.
Built for Complex Regulatory Requirements
Powered by Microsoft Dynamics 365
Merit for Regulated Industries is a comprehensive cloud ERP solution that advances the capabilities of Dynamics 365 to meet the unique requirements of regulated manufacturers. Our industry-tailored solution provides an additional suite of features that cater to the needs of businesses operating in highly regulated environments such as food and beverage, chemical, alcohol and tobacco, cosmetics, and aerospace. These incredibly different industries have one thing in common: the need to follow and demonstrate strict regulatory compliance.
Merit for Regulated Industries provides the robust feature set needed to establish and maintain quality, procurement, production, and inventory and warehouse controls. If you have questions, contact one of our select Merit Solutions partners listed below or Contact Us and we’ll connect you with a solution provider in your area.
Quality Controls
The quality functions in regulated manufacturing are under pressure due to an extraordinary level of governmental scrutiny and regulatory enforcement. Progressive regulated organizations are taking a new approach to quality that allows quality information (commonly held in a QMS) to be leveraged across the organization. The result is more effective vendor negotiation, faster resolution of deviations, and quicker root cause analysis, ultimately leading to safer and compliant products.
Benefits:
- Track quality metrics
- Manage non-conformance
- Ensure products meet GMP requirements
- Enforce digital controls
- Ensure compliance
Here are a few areas where we advance the quality control capabilities of D365:
Audit Trails and
E-Signatures
Corrective and Preventive
Actions (CAPAs)
Quality inspections
Quality Incidents and Complaints
Quality Audits
Electronic batch/device record report
Production Controls
Now more than ever, you must be confident in the technology that is automating your operations. Whether collaborating with trial sites, CROs, CDMOs, 3PLs, working through peer reviews, or other partnerships, or simply managing internal operations, having the production controls in place that help ensure you pass inspections and audits is critical.
Benefits:
- Shorten order production and delivery times by streamlining your supply chain
- Leverage model-driven planning engines with actionable insights to order and produce materials and meet your demand
- Validate that your production workforce is trained and certified for the task at hand
- Ensure every production operation, material, resource and equipment used, quality inspection results are being recorded into a comprehensive EBR report
Here are a few ways we advance the production control capabilities of D365:
Weighing and Dispensing
Finished product quality testing and release
Training compliance
Electronic batch record report
forwards and backwards lot tracing controls
product labeling
Procurement Controls
Having effective controls in place, such as monitoring supplier performance, assessing risk, and proactively implementing contingency plans, can help you identify potential issues early and respond to them quickly. With better procurement processes and controls, you’ll enhance the transparency and collaboration of your supply chain, and reduce the likelihood of delays. That means products are delivered on time and meeting the required quality standards.
Benefits:
- Enforce system controls to prevent engagement with non-qualified vendors
- Create, plan, and manage vendor audits to reduce downtime
- Gain insight into vendor delivery and quality performance to ensure GxP compliance
- Keep things running smoothly and on schedule
Here are some of the areas where we’ve advanced D365 to better procurement processes and controls for regulated industries:
Vendor certification, audits, and approvals
Manufacturer certifications and vendor classification levels
Raw material labeling, release, and quality inspections
Vendor performance management and supply chain risk assessment
Inventory and Warehouse Controls
One of the biggest hurdles for any organization in predicting and achieving consistent growth is disruption in the supply chain. Organizations slow to digitalize the supply chain and burdened by rigid ERP solutions face challenges in planning for demand and mitigating supply chain issues.
Benefits:
- Real-time lot status visibility
- Material movement traceability
- Storage condition(s) controls
- Simplified and accelerated processes
- Electronic configuration, creation, and capture of all material details and transactions
Take advantage of the D365 advancements we’ve made to drive better inventory and warehouse controls:
Batch/lot registration and tracking, splitting, and genealogy
Shelf life, expiration, and
re-test; Finished goods stability
forward and backward lot tracing controls
Integrated storage (condition)s controls
Integrated labeling, shipping, and tracking
Document Controls
Proper document management and control are critical for any regulated industry. All documents related to the manufacturing process, from product development to post-market surveillance, must be managed and controlled effectively.
By ensuring that all documentation is complete, accurate, and readily accessible for internal and external audits, inspections, and regulatory submissions, you can be confident in your ability to maintain compliance with regulatory requirements.
Benefits:
- Gain control of quality SOPs, validation documents, compliance documents, process specific instructions, analytic procedures, and more
- Create documents, manage revisions, and route for sign-off, all while eliminating delays
- Manage critical business documents, knowing they are always available in a scaleable, digital locker
- Ensure consistency and quality in the manufacturing process and maintain an accurate and comprehensive document trail
- Identify and address any issues that may arise during the manufacturing process
Our expert partners can provide you with the tools and support you need to ensure compliance, maintain quality, and protect your reputation and financial performance. Contact them today to learn more.
Teaming Up to Deliver the Right Solution to You
These Microsoft and Merit Solution partners have deep and proven market expertise in the life sciences and other regulated industries and have chosen Merit Solutions to complete their portfolios. They will work with you to implement a solution tailored for the complex regulatory needs of your organization. Together you will transform your business processes to improve profitability and efficiency, acclerate growth, and maintain compliance in a secure, modern cloud environment.
Select a partner below to learn more about their capabilities or Contact Us for more information.
