Leverage your Existing Investments in Technology to meet 21 CFR Part 11 Requirements

Regulated document management for efficient collaboration, extensive search and enhanced security

Does any of the following sound familiar?

• R&D processes bogged down in regulatory paperwork

• Too much money spent on creation and storage of paper-based documentation

• Lack of understanding and little use of compliant content management systems

• Delays due to having only one compliance expert posting documents into a repository

• Less than satisfactory speed-to-market

All these challenges arise from the requirement of complying with 21 CFR Part 11 regulations.

In view of the demand for an IT solution to address these challenges, the market today is flooded with several flavors of document management systems. There are a number of document management systems which offer the workflow controls necessary for compliance: however, these controls are not always ideal for efficient document management. Common challenges include complex user interfaces and slow user adaption, cumbersome editing and approval processes, lack of effective collaboration tools and difficulty locating files across data sources. Each one of these challenges is compounded not only by the number of people working on a document but also by the sheer volume of forms and data involved in drug development, approval and production.

At i³, we have built a framework for document management solutions which is based on the three key pillars of Collaboration, Search, and Security, as detailed in the figure below.

As a Microsoft Gold Certified Partner, we have extensive experience in implementing solutions based on Microsoft technologies including Microsoft Office SharePoint Server (MOSS) 2007. Microsoft’s new collaboration platform based on MOSS 2007 is best suited to meet compliance requirements laid down by FDA under 21 CFR Part 11. This is evident from the available features of MOSS 2007 displayed in the table below.

Other Document Management Capabilities

• New, compressed files formats: 50-75 percent smaller than equivalent documents from the 2003 Microsoft Office System

• Unified search capabilities: Connect to a variety of other information sources, including the Web, databases, and enterprise applications

• Easier filing and metadata management: Enter metadata directly from the document information panel in the 2007 release of the Microsoft Office system

• More efficient collaboration: Manage regulatory documents while also benefiting from the collaboration features of SharePoint® Products and Technologies

• Multiple document security features: Convenient single sign-on can enable multiple repository access to qualified users. Information Rights Management (IRM) can help control unauthorized actions (such as forward, paste, or print) by disabling those functions in IRM-protected documents. Word documents can also be converted automatically to fixed PDF format.

i³ can help customers in the life sciences industry make the most of their investments in Microsoft technologies by leveraging our strong capabilities and experience in implementing solutions based on Microsoft SharePoint Server collaboration platform.

To help us understand your specific business needs, call us at 973-535-3445 or write to Rajeev.Desai@i3intl.com