Microsoft Dynamics 365 (D365) is a robust and well-known ERP system, but can it be used in the heavily regulated Life Science industry? Sure, it can. And, with the help of additional ISV tools, you can ease the validation burden that comes with applying D365 in Life Science.
At Epista, we believe Dynamics 365 is well-built for pharmaceuticals, biotech, and medical device manufacturers. We also know that the market for add-on products is growing. You might even say it’s a jungle out there, with many tools and vendors to choose from including accelerators and automated testing tools. So, to help with your investigation, we’ve compiled a list of selected Life Science-relevant ISV tools for Dynamics 365.
Cegeka is a system integrator with a dedicated, Life Science-focused solution for Dynamics 365 called Cegeka Dynamics for Pharma & Life Sciences. The solution offers enhancements for SCM, production, and quality, but this article specifically focuses on the suite’s electronic signature feature for Dynamics 365.
Advantages: In the standard functionality of D365, there are a few known issues with the electronic signature functionality, such as an inability to limit the number of log-in attempts by a user.
Cegeka’s Dynamics solutions for Pharma and Life Sciences has a built-in parameter to combat this, making it easier to comply with 21 CFR Part 11 from the FDA and EU Annex 11. It also allows companies to put specified security measures in place alongside the electronic signature requirement to protect against, and to detect, unauthorized access to their ERP system.
Use Case: Dynamics 365 lets you configure electronic signatures for many relevant GxP areas, such as batch release, recipe approval, and the like. Using Cegeka’s tool, Life Science companies that use these electronic signatures can ensure they meet industry requirements and protect their data.
To learn more about Cegeka’s Life Science suite, visit Microsoft AppSource.
DXC Technology is a system integrator with a suite of software solutions, including DXC Advanced Customer Approval. This Dynamics 365 add-on allows you to define the customers and countries to which you can sell individual items - and under which specific terms and conditions.
Advantages: DXC’s tool ensures that validation is performed on a given sales order when creating the sales order lines. This helps the sales team manage the regulatory restrictions on the supply agreements and prevents them from shipping products to geographies in which they have not yet obtained authorization.
Use case: DXC Advanced Customer Approval is relevant for any Life Science company that uses Dynamics 365 sales orders to distribute finished goods.
To learn more about DXC’s Advanced Customer Approval, visit Microsoft AppSource.
To-Increase is a business software solution provider. They’ve developed Security and Compliance Studio, a comprehensive add-on tool that helps Life Science companies manage security when using Dynamics 365.
Advantages: The Life Science industry must meet many requirements, especially when it comes to security. For example, GAMP5 states that “all access right change events must be recorded”. The standard functionality of Dynamics 365 does not provide an audit trail that can record these events. Security and Compliance Studio provides a full audit trail and traceability for all current and past security roles and users or groups.
Use Case: Security and Compliance Studio is an Epista preferred tool. Security roles are important for all Life Science businesses. That’s why we recommend To-Increase for supporting access management, internal QA processes, and external audits.
To learn more about To-Increase’s tool, visit Microsoft AppSource.
Automated Boost is a no-code, automated test tool for the Life Science industry that helps you manage the frequent updates and releases of a cloud-based ERP system.
Advantages: It’s a challenge for Life Science companies to maintain the validated state of Dynamics 365. Each update requires extensive regression test, for one thing. Boost automates the testing workload, and works across applications, unlike many other test automation tools, including the Azure DevOps’ standard test tool. Boost also works with Azure DevOps as a test management tool. You can trigger test execution directly from DevOps, and report results directly back to DevOps.
Use Case: If your Life Science company is looking for an intuitive, no-code automated test tool with a test scope that can span multiple systems and platforms and can integrate directly into DevOps, Boost might be right for you. Automated Boost satisfies the heavily regulated GxP requirements of the Life Science industry, doesn’t require coding, and works well with an agile methodology.
For more information on Automated Boost, visit Microsoft AppSource.
AX For Pharma is a system integrator with a dedicated, Life Science-focused suite of tools for Dynamics 365 called AX for Pharma 365. In this article, we focus on the built-in LIMS system that includes tools to facilitate quality ordering, sampling plans, reduced testing, acceptance criteria, certificates of analysis/conformance, stability studies, configurable approval workflows, and electronic signatures.
Advantages: Some companies find increased transparency and improved productivity with a LIMS embedded into their ERP system, rather than having a standalone LIMS. It can improve processes between the supply chain, manufacturing, and quality areas by providing one source of truth within the ERP system rather than having data residing in separate systems.
Use Case: The LIMS functionality in AXP365 Advanced Quality Management has the potential to benefit pharmaceutical companies that does not already have a native LIMS system.
For more information on AXP365 Advanced Quality Management, visit Microsoft AppSource.
Need more guidance?
At the risk of repeating ourselves, it’s a jungle out there when it comes to ISV tools to add business value and ease the validation burden of Dynamics 365. Epista can help. It’s our mission to continuously improve compliance and business in the Life Science industry. We can help you plan for, validate, implement, and operate your Dynamics 365 ERP system - all while living up to the heavily regulated GxP requirements of Life Science.
Are you looking to increase the business value of your Dynamics 365 system? Get in touch and one of our experts will reach out to you!