Epista can help you plan for, validate, implement, and operate your ERP system - whether it’s Microsoft Dynamics 365, SAP S4/HANA, or another - all while living up to the heavily regulated GxP requirements of Life Science.
You’re an expert in your field. We’re experts in ERP systems for Life Science. Based on many years helping many clients with many ERP implementations, Epista has developed a cost-effective validation approach.
Yes. Epista gives you the domain expertise you need to be efficient and in control. Many of our validation services are built with templates so we can be up to speed quickly. We apply a risk-based approach using our deep knowledge of the GxP-affected areas of the Microsoft stacks. Our ERP validation methodology is fully integrated into the implementation approach and follows industry standards, such as ISPE’s GAMP guidance. And yes, we can help you use Azure DevOps in a validated environment. Read on for all the details.
There are many stakeholders involved in an ERP project for Life Science. Epista understands their needs and priorities when implementing and validating a cloud ERP solution. Our methodologies and accelerators build a bridge between the domains of compliance, business, and IT. Furthermore, we know the relevant system integrators, the accelerators, and the Life Science best practices. And most importantly, we know how to optimize and integrate all of these elements with your specific strategies and needs.
Through years of implementation and validation projects across different ERP solutions and Life Science Accelerators, Epista has gained substantial knowledge regarding best practices that support your company’s specific needs and goals. The challenge is that no two Life Science companies are identical, so even though there are many best practices within Life Science, you still need to adapt and shape them into the specific context that fits your company. This is why experience matters.
Epista can help. To succeed with your cloud ERP transition, we’ll provide insights and best practices that give you:
And Epista’s best practices achieve this in a way that bridges the needs of all stakeholders – Business, Quality, IT, and your implementation partner.
Agile implementations have traditionally been a “no-go” in Life Science. Yet, today most ERP vendors for pharmaceuticals suggest just that implementation approach for their Life Science clients. Why? Because this approach increases efficiency, flexibility, and speed in our highly complex and ever-changing world.
The challenge is: How do you write a URS for a new way of working that is still developing? How do you combine Agile with a Life Science’s traditional V-Model?
Epista can help you to balance agile implementation and validation. We’ve developed tools and methodologies to achieve the desired agility while also satisfying QA’s need for control and traceability.
The comprehensive stack of validation documents provided by SAP, Microsoft, and other vendors can be overwhelming - especially to those inexperienced with Cloud/SaaS qualification. Epista's deep expertise gives you a proven path to success. We know what needs to be read and reviewed, what vendor documentation can be re-used, and more. Instead of reinventing the wheel, you'll have the confidence that comes from being supported by reliable industry experts.
Epista offers consulting on the full cloud ERP journey for pharmaceutical, biotech, and medical device companies. We can tailor a package to support a successful implementation, including:
Cloud ERP project preparation:
An Epista Enterprise Architect will help you prepare your requirements and search for the most suitable vendor candidates. We’ll help you set the scope and decide whether to include manufacturing execution, weighing, dispensing, serialization, asset management, or other related needs optionally supported by ERP.
Validation Lead and Support:
Our compliance experts will deliver a validation plan and validation support by adapting standard material from your supplier(s), control test and documentation deliverables from the implementation project - and ensure compliance with your internal procedures and requirements.
A project manager is responsible for overall service deliverables, project oversight, and progress. They’ll use well-established project governance tools and methods based on our extensive experience implementing Cloud ERP systems.
Business Process Optimization:
A subject matter expert with strong industry knowledge will analyze your business practices and future business strategy, and then develop and lead process harmonization and optimization activities.
Configuration Support (Microsoft only):
A technical expert will guide you through configuration decisions to ensure the right ones are being made. By setting the right priorities now, we help you get the most out of your new solution.
Organizational Change Management:
Implementing a cloud ERP system will bring major change to your organization. An Epista specialist will establish proper communications, manage stakeholders, and create a full onboarding and training program for end users.
Test Management including automated test:
A Test Manager will design your test strategy, balancing manual and automated test activities. They will lead and control testing activities ensuring full traceability and proof, from your requirements to final documentation.
Operation & Maintenance (Managed Operations):
A Managed Operations expert will establish an elevated level of support for seamless adoption of the new system in cooperation with your ERP operations vendor. This will allow you to focus on your business after implementation, while we establish and operate compliant change and release processes to ensure business continuation and that new features and functions are utilized to maximum value. This way, your system will continue to support your business, rather than the other way around.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.