epista IT ApS
- Denmark, Switzerland
- Service category
- eData - IT - software
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With epista IT, you will get expert compliance support all the way through your IT system’s life cycle
General compliance consulting
epista IT has more than 100 man-years of experience in formulating compliance strategies for a wide range of IT systems, serving both large and small organizations. This experience enables us to scale compliance strategies to suit any business – defining the perfect balance between risk, cost and compliance.
IT system implementation and validation
Our structured GAMP based project methodology invests the proper time in the analysis phase of your system implementation. The only way to formulate a validation strategy is through real risk assessment dialogue between QA functions and IT / business functions – facilitating a common understanding of regulatory requirements and the technical architecture of the system.
epista IT is focused on validation of a large variety of systems with a specialty in the validation of:
- ERP (Enterprise Resource Planning);
- QMS (quality management system);
- EDMS (electronic document management system); and
- SharePoint infrastructure.
We integrate requirements from 21 CFR part 210, 21 CFR part 211 and 21 CFR part 820 into the solution and validate according to the GAMP guidelines.
Is your IT department ready for inspection?
With the FDA’s release of 21 CFR Part 11 and the EMEA’s release of Annex 11, inspectors have invited themselves into the IT departments. As a consequence, a sound quality management system needs to be established to cover the processes. We will provide you with the necessary policies and procedures that support your daily IT operations. We can also perform “unofficial” quality audits in order to prepare your IT organization for inspections and customer audits.
Document and Quality Management Systems
Structured documentation means quality and a shorter time to market
Implemented correctly, document and quality management systems significantly increase productivity, reduce cost, ensure quality and speed your product to the market.
To achieve this, it is crucial for any Life Science company to search, select and implement solutions that fulfill the business requirements defined by the quality, clinical and regulatory departments, in addition to complying with regulatory requirements, like 21 CFR Part 11.
Accelerate your search and selection process
epista IT’s deep roots in the Life Science industry combined with our solid hands-on experience and advanced knowledge of the IT products specifically designed for Life Science businesses will quickly bring you to the optimal compliance solution that solves your quality, regulatory, IT and business needs.
We offer the tools and methods which accelerate requirements formulation, define clear evaluation criteria and involve your decision-makers from the regulatory, quality and clinical departments.
Implementation – why reinvent the wheel?
epista IT has developed best practices for implementation. These best practices are workshop-driven and are a proven starting point for defining content types and metadata, workflows and security, which are aligned with the requirements from the regulatory, quality and clinical departments. epista IT’s best practices are based on years of experience with implementation of compliance solutions for Life Science companies.
Clinical and Investigator Portal
Speed up your clinical trial process through secure and efficient collaboration
Improving efficiency during clinical trial processes is one of the strategies adopted by Life Science companies to reduce costs and speed their products to market. And, as companies increase their global presence and outsource some of their business areas, the need for greater and more efficient collaboration capabilities becomes more essential than ever.
The traditional paper-based methods of document exchange, approvals and version management are very time-consuming and normally entail delays and high costs with express deliveries, storage and search of documents, among other tasks. On the other hand, online document exchange through e-mail or fax is not sufficiently secure.
Investigative sites deal with a growing number of studies from different sponsors, and therefore have to keep track of the documentation from each study. Trial teams, in turn, need to stay up-to-date on the progress of the studies in each site.
A web-based clinical portal can help improve this process. Designed correctly, it enables easy, cost-effective and secure document exchange as well as facilitates collaborative activities between internal and external stakeholders involved in clinical trials.
epista IT will help you implement the right clinical portal solution
When selecting clinical portal software, multiple aspects must be taken into account, ranging from security, quality and regulatory requirements to user-friendliness, and from investment and operational costs to integration with IT platforms and other systems, just to name a few.
epista IT can help you map and analyze all requirements involved in the selection of the right clinical portal solution for your business. You can also count on our support for implementation and validation, using risk assessments based on GAMP best practices and the 21CRF Part 11 regulation.
DeltaPoint – SharePoint governance
DeltaPoint helps you achieve efficient SharePoint control
A versatile platform, Microsoft SharePoint has been adopted by many pharmaceuticalcompanies as the backbone for Document and Quality Management systems as well as Clinical and Investigator Portals, housing controlled and regulated content that requires to be hosted within a controlled environment.
However, if critical configuration parameters and shared services are not properly managed on SharePoint, its numerous functions and settings can easily spin out of control. It becomes even more difficult to keep track of the interdependencies between critical parameters when validated and non-validated business applications co-exist within the same SharePoint infrastructure.
DeltaPoint is a governance approach that enables efficient SharePoint control during all phases of a SharePoint platform implementation, from design to maintenance. It starts with detailed installations guides followed by a thorough identification and documentation of all critical configuration parameters. To facilitate change control and configuration management, epista IT has developed a governance tool which extracts and compares configuration baselines automatically, generating baseline reports that cover the whole SharePoint infrastructure.
The DeltaPoint governance solution also includes policies and procedures that ensure consistency during operation and maintenance of the SharePoint farm and its applications.
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