Compliance Consulting

IT solutions that add value to your business.

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Technology and compliance…

These are the two main ingredients of a Life Science IT solution. Technology is supposed to make it easier and cheaper to achieve compliance. But does it always work that way? Are the IT/business functions of your company on the same page as your QA department? Do they have the same goals and priorities? All areas are on the same team, but due to the unique nature of a Life Science business they often seem to pull in different directions.

That’s because IT departments and business functions are focused on cost, resource usage, collaboration and other commercial goals. On the other hand, QA departments by definition are focused on interpreting and understanding regulatory requirements and validating all systems for compliance with these regulations – regardless of the cost.

Experience clearly shows that the very solutions aimed at bringing these perspectives together are often undermined by lack of mutual understanding between internal groups.

Putting technology into play

Real solutions that add value must be based on a deep understanding of Life Science business processes, interpretation of compliance regulations and expertise with the relevant technology. epista IT can help you navigate the technology minefield between business risk and regulatory compliance. You won’t find any other consultancy with our combination of these skills.

Real solutions

Fostering a common understanding across all areas of your business creates real solutions that succeed in achieving your goals. epista IT has a proven track record doing exactly that.

Real compliance: Minimize your validation burden using a risk based approach - including all the elements of a full GAMP project model. Use our experience to make your software validation faster, easier and more cost effective: SharePoint, ERP , production, submission systems and more.

Real experience: Get robust solutions that improve your business processes. epista IT’s deep industry knowledge means that we understand your business processes, are experts in your regulatory requirements and can implement IT solutions that add value to your business.

epista IT’s services

• General Compliance Consulting: epista IT can help you balance risk, cost and compliance. We’ll share our experience establishing validation policies for IT implementation projects.
• eSubmission /eCTD: We can assist you in the search and selection of an eSubmission solution and help you implement the system.
• EDMS: Regulatory electronic document management systems. epista IT can assist you in the search and selection of an EDMS platform. We can also help you implement the enterprise EDMS based on the leading Life Science specific platforms such as FirstPoint, MasterControl and more.
• MOSS 2007 Compliance: We can help you obtain full MOS 2007 compliance using a risk based approach utilizing best IT governance practices and GAMP.

Partners

Our valued partners are all engaged with products specifically developed for the Life Science industry:

• CSC – FirstPoint, EDMS system based on MOS 2007
• InnovoCommerce - Delivering SharePoint Based Compliance Solutions

You can count on us

We realize the magnitude of the tasks we are involved in. That’s why we stake our reputation on these core values:

• Credibility: To us, this consists of two elements: trust worthiness and expertise.
• Mutual respect: We learn, appreciate and reinforce our partner’s skills and strengths. This applies to our clients as well as our employees.
• Competence: We possess a deep knowledge of the Life Science industry, have advanced expertise with the relevant technology and set a high priority on strong interpersonal skills.
• Relationships: We build long lasting relationships with our clients, partners and employees.