Clients, both large and small, seek assistance from Epista for many reasons. Some need help to change their IT landscape. Others need assistance to understand and conform to new regulations. Still others want help to find the appropriate compliance level for their organization. Epista has assisted clients with all facets of regulatory compliance.
Being in compliance means fulfilling specific quality goals. Using Epista’s structured methodologies, our clients identify exactly where to set the bar so quality levels fit both regulatory requirements and their business objectives. They figure out where they are now and where they want to go. Then, with Epista’s help, they get there.
Nearly 100 clients have chosen Epista to help them advance their compliance. They span the globe and range from pharma, biotech, medical devices, CRO, CMO and pharma-related. Read about a selection of our clients and projects, below.
Contact us: Need help to understand and conform to new regulations? Change your IT landscape? Find and achieve the appropriate compliance level in your organization? Get in touch! We enjoy sharing our knowledge and are happy to discuss advancing regulatory compliance in your company:
Epista primarily delivers Microsoft SharePoint projects in the Biotech sector. These include qualification of the Microsoft SharePoint platform and a full implementation and validation of applications, Electronic Clinical Trials Portals and Electronic Document Management Systems developed by various solution providers. One reason we’re successful at creating value for our clients is our deep understanding of the Biotech industry’s business requirements and our experience in getting the job done with the scarce resource situation that typically exists in this sector.
We have assisted many large and mid-sized companies with projects in many areas. These include IT Advisory Services, Compliant Microsoft SharePoint implementations and Search & Selection of Electronic Document Management Systems.
Epista has most recently been involved in the qualification of two global Cloud solutions for a Tier 1 pharmaceutical company. Our extensive experience regarding IT Compliance and Validation in an FDA regulated industry enabled us to execute Qualification of Microsoft Office 365 and Azure/Drupal. These projects were groundbreaking at the time. We have also recently delivered Microsoft SharePoint qualifications, implementation and validation of Electronic Document Management Systems, Electronic Clinical Trials Portal, Electronic Quality Management Systems and ERP Systems (SAP).
Some of our largest clients have their HQ in central Europe, primarily in the pharmaceutical industry and biotech sector. We add value to our clients by executing various projects such as IT compliance and validation services, IT quality advisory and Microsoft SharePoint qualifications.
Founded and Headquartered in Copenhagen, many of Epista's projects are delivered to Life Sciences clients in Scandinavia. Clients range from small biotech companies employing only a few people to global pharmaceutical manufacturers with +40.000 employees. With the increasing focus on Medical Device manufacturers regulatory and quality systems, Epista is also assisting many clients in this segment. Projects:- Implementation and validation of ERP systems based on SAP and Microsoft Dynamics AX- Global Serialization- Inspection Readiness- Microsoft SharePoint Qualification- Implementation and Validation of Electronic Document Management Systems, Electronic Quality Management Systems, Electronic Clinical Trials Portal, Electronic Submission SystemsAdvisory & Consulting:- IT Quality Strategy- Validation Strategy & Plans- ITQC & ITQA- Serialization Project Strategy
For global Medical Device manufacturers, we have implemented Microsoft SharePoint based Electronic Document Management systems covering quality, manufacturing documentation and change control. The SharePoint Qualification tool DeltaPoint is used for SharePoint Qualification.
We have worked with large global pharmaceutical companies implementing Microsoft SharePoint based Electronic Document Management Systems. Epista gathers requirements, configures, installs and validates R&D solutions. This includes qualification of SharePoint 2010 using the DeltaPoint product.
Epista has implemented and validated SharePoint based Electronic Document Management systems. Clients get extensive value from the qualification of Microsoft SharePoint and the customized configuration to meets their specific requirements.
Epista helps clients find doc management solutions as well as systems to improve quality processes such as deviations and changes. Our in-depth knowledge of the relevant technology and solution providers gives a complete overview of options. Clients use our expertise throughout the search and selection process with workshops on User Requirement Specifications, technology and strategy.