WorkinWith integrator for Merit Solutions in Europe
In collaboration with Merit Solutions, WorkinWith experts offer comprehensive support to companies operating in the Life sciences sector.
These industries face ongoing challenges, from streamlining their supply chains to accelerating time-to-market, while adhering to increasingly complex compliance regulations...
Merit for Life Science is a Cloud ERP designed specifically for manufacturers of biotech, pharmaceutical and medical products.
It leverages Dynamics 365 Finance and Operations, WorkinWith's core business, to connect your entire organization:
- Matching resource qualifications to production requirements
- Maintaining relationships with suppliers as part of the procurement process to ensure quality standards are met during manufacturing
- By providing your organization with the visibility and transparency it needs to deliver safe, innovative products.
- By enabling you to benefit from a wide range of features to improve your organization
- As your partner, we know that your organization has unique needs that we understand thanks to our experience in the Lifescience market.
Accelerating innovation in Life sciences
To compete in the world of biotechnology, pharmaceuticals and medical devices, you have to be ready to handle volume before it gets too big. There's no time to waste on spreadsheets and manual processes!
With Merit for Life Science, you have the tools you need to increase manufacturing productivity, reduce time-to-market, and plan for production and growth.
You'll be well on your way from start-up to commercial success - and in record time.
FINANCE
- Evaluate and implement appropriate financing models to reduce the expense burden of licensing agreements or other partnerships to ensure fiscal efficiency.
- Make informed decisions regarding the development of your organization.
- Establish financial reporting standards for acquired entities or to prepare for an acquisition.
- Transform your operations from disconnected silos to collaborative departments.
- Improve your decision-making process with reliable, auditable accounting practices.
PRODUCTION
- Electronically manage material evaluation and activity, equipment calibration, and device and batch history management, across multiple manufacturing modes.
- Track the handling of raw materials throughout their preparation, digitally capturing processes and ensuring that everything verifiable is carried out in accordance with SOPs and batch-specific requirements.
Implement a model-based planning engine to obtain real-time information on when to order or purchase products, or produce certain materials, thus shortening order cycle times. - Digitally track material batch status to reduce human error, and apply software controls for material batch status changes and material movements.
- Divide batches into multiple lots or sub-batches to improve and manage downstream processing.
- Use real-time data to maximize resources and achieve better results in terms of production schedules.
- Reduce the complexity of tracking various business process parameters, as well as employee training and certification.
- Deliver products on time with unprecedented accuracy.
DIGITAL EXPERIENCE
- Digitize your customers' interactions, ensuring that everything is done securely and in compliance with FDA standards and other regulations in force in your country.
- Automate processes such as technique management, specifications, approvals and various other steps during the “customer preparation” or “batch preparation” phase. Reduce cycle times and processes between the time an order is placed and the start of production.
- Enable your team to work with the latest and best digital applications to optimize process management throughout your organization.
- Eliminate time-consuming manual tasks and make life easier for your employees, while improving their productivity.
- Transform some of your information into data that the system can use to recognize patterns, enabling you to
make better decisions and become even more efficient.
Life Sciences industries face a number of unique challenges when it comes to implementing an ERP system:
- Complex regulatory requirements: ERP systems must be able to comply with various regulations, such as 21 CFR Part 11 (electronic records and signatures) and EU Annex 11 (computerized systems).
- Stringent data security and confidentiality requirements: Lifesciences processes sensitive and confidential data, such as patient information and proprietary research data. The ERP system chosen must be able to guarantee the protection and security of this data.
- Managing multiple sites and remote workers: many companies in this sector have multiple sites and remote workers. The ERP system must be able to effectively manage and communicate data between these different sites. ERP must be able to effectively manage data confidentiality throughout the process.
- Batch tracking and inventory management: these organizations often have a large number of products with short shelf lives and complex tracking requirements, such as expiration dates and batch numbers. The ERP system must be able to manage and track these products efficiently.
- Quality management: they are required to comply with strict quality control standards. The ERP system must be able to support quality management processes, such as tracking non-conformances and corrective actions.
- Integration with other systems: these organizations are often equipped with various specialized systems, such as laboratory information management systems (LIMS) and electronic laboratory notebooks (ELN). The ERP system must be able to integrate with these other systems to ensure seamless workflow and data sharing.
Manage your organization with solutions developed by Merit and implemented by the Microsoft experts at WorkinWith!
Pharmaceutical, biotech and medical companies need an ERP system specifically tailored to their needs. These organizations navigate a maze of increasingly stringent regulations, combined with ever more demanding customer expectations.
The ERP system chosen must oversee demand forecasting, production capacity planning, incident management and inventory management.
Merit for Life Science takes the financial and operational (ERP) capabilities of Microsoft Dynamics to the next level, providing a tailor-made solution for these industries' rigorous requirements.
With Merit for Lifescience, regulated manufacturers can improve process efficiency, prepare for rapid growth, continue to drive value creation while maintaining FDA CFR 21 part 11 and part 211, EMA Annex 11, and country-specific regulatory compliance.
Working with Merit throughout your project, our experienced team implements, advises and understands your operational, manufacturing and compliance challenges.
