Electronic Document Management

Electronic Document Management (EDMS)

Improve your time to market with better control of your paper jungle.

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Get in control

How much time does your average employee spend handling documents? Today’s Life Science companies are facing an ever growing jungle of electronic and paper documentation. Without proper control they can clog the channels of communication and block the flow of work. And when you add an increasing list of regulatory requirements you are faced with a problem that can send productivity and quality plummeting!

An electronic document management system (EDMS) covering both regulatory and non-regulator areas can solve this problem. But the requirements for such a system are not limited to simple management and versioning of documents. To get the full ROI on your investment, a modern Life Science EDMS must span your enterprise from workflow issues to 21 CPFR part 11 – and even out into the Production and Sales business functions. In fact, recent studies show that the clear trend in the Life Science industry is towards the use of Microsoft SharePoint as this platform.

Requirements

A successful Life Science EDMS must address these issues:

Support of many document types – Handling document types with different compliance levels is essential to cover regulatory as well as non-regulatory business areas.
Integration with more systems – Integration to training management systems, production systems and especially eSubmission tools is critical.
More internal collaboration – Requires integration with Microsoft Office or other authoring tools to enable change tracking and checking in and out, etc.
Complicated workflow – Parallel reviews and even CAPA’s must be implemented either as part of the EDMS or closely integrated with the EDMS .
External collaboration – Since development is often done with partners, external collaboration support is also a must.

A real solution for Life Science requires a deep knowledge of these business requirements, a clear understanding of the related compliance requirements unique to Life Science and experience with the technology that supports these challenges. epista IT can help. We’ll give you a head start on a successful EDMS. regulatory document management

Benefits

Implemented correctly, EDMS significantly increases productivity, reduces cost, ensures quality and speeds your product to market. By taking advantage of epista IT’s best practice experience in the Life Science industry you won’t have to reinvent the wheel. You’ll get the document templates, workflow processes and content types you need for compliance validation. You won’t get this intellectual property from any other Life Science consultancy. Just think how your business will benefit with one common enterprise-wide platform for document management.

Platform Selection

Based on a long history with regulatory EDMS, epista IT can assist in selecting the right EDMS platform for your company. We’re familiar with Life Science specific platforms and can help you with direct, structured comparisons.

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
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 provide all of the intellectual property you need for compliance: document templates, workflow processes and content types.

epista IT implements solutions based on:

Standard MOSS 2007
FirstPoint