Services > Document and Quality Management Systems

 

 
A well proven project methodology

 
epista IT’s project methodology has been widely used and have created a proven track record of successful results.

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Platform Search and Selection
Based on a long history with quality and document management systems, epista IT can assist in selecting the optimal platform for your company. We’re familiar with Life Science specific platforms and can help you with direct and structured comparisons. The methodology for search and selection with epista IT is as follows:

Initial market scan – epista IT will as an independent party provide information about the leading vendors of Life Science specific document and quality management systems

Facilitate demo’s – for the selected systems epista IT will facilitate demonstrations in order to clarify which functionality is required and can be delivered by each vendor

Development of generic URS – To do this, we hold a workshop for all relevant stakeholders. The result is a product independent user requirement specification (URS).

Fit/GAP analysis – epista IT can assist in due diligence of products with respect to:

• All functionality, including Life Science specific requirements;
• Pros and cons of IT architecture;
• License cost / lifetime cost; and
• QA and validation effort

Implementation
To begin, the Functional Definition Phase uses a workshop approach to gather specific requirements and to teach all relevant stakeholders how the solution works.

Examples of details needing specification are:

• Document types and contents for departments;
• Metadata for each document type;
• Work flows;
• Integration with department specific systems;
• Validation strategy

Upon completion of the Functional Definition Phase, documentation is developed upon which the rest of the configuration and validation will be based upon, including:

• Product Specific URS;
• Functional Specification;
• Validation Plan

With epista IT on your team you get a head start to success
We will provide all of the intellectual property you need for compliance: document templates, workflow processes and content types.