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 Challenges
Why Choose the Microsoft Office System?
Microsoft Office System Products
ChallengesAlthough many solutions claim 21 CFR Part 11 compliance, the cost of these systems is often prohibitive for all but the largest life sciences organizations. At the same time, many solutions are difficult to deploy and even harder to use, which further limits their ability to create compliant-environments quickly and effectively.
Why Choose the Microsoft Office System?To rapidly address 21 CFR Part 11 challenges, the 2007 Microsoft Office system is the ideal choice. New technologies built into the 2007 Microsoft Office system can help in the following ways: Simplify the management of complex compliance process | • | Users can easily initiate a wide range of automated workflows directly from Microsoft Office Word 2007 or Microsoft Office Excel 2007, including reviews, approvals, edits, requests for digital signatures, and feedback | | • | Administrators can track each workflow and monitor how it performs overall, as well drill down into specific instances of a workflow | | • | Content types allow administrators and compliance managers to pre-define templates so that all new documents of a given type are automatically assigned the appropriate policies, such as workflow, resulting actions, and expiration |
Perform detailed audit analysis | • | Microsoft Office SharePoint Server 2007 allows administrators to audit key events within document libraries and monitor global events on a site (such as search, user changes, and changes in content types and columns), which creates evidence of who accessed which resources at what time | | • | A central administration site makes it easy to configure various settings for auditing, such as selecting specific events to audit | | • | Auditing functionality can be extended using a Web service or by using the audit log service object model, so other applications can provide a full audit when their files are stored on a SharePoint site |
Protect data with more powerful security features | • | Users of the portal are authenticated automatically based on their role and user information from Active Directory | | • | Information Rights Management (IRM) policies can be applied to both individual documents and entire libraries, making it easier to get consistent use of IRM across a set of documents without creating extra work for individual users | | • | The applications of the 2007 Microsoft Office system automatically assess the authenticity of digital signatures and signed documents, and alert the administrator if there are any discrepancies | | • | A records repository facilitates security-enhanced document management processes, including content collection, consistent policy enforcement, item retention and holds in response to external events, and content expiration |
Reduce administrative costs with new tools and formats | • | New, XML-based file formats for Microsoft Office Word 2007, Microsoft Office Excel 2007, and Microsoft Office PowerPoint 2007 can allow these documents to easily integrate with existing and future line-of-business systems | | • | Office Open XML Formats use ZIP compression technology, so documents take up far less space than the previous formats, which means shorter transmission times and a smaller impact on storage | | • | The Office Customization Tool simplifies customization simple and efficient by replacing the many wizards that were necessary in previous releases of the Microsoft Office |
Leverage deployed Microsoft technologies | • | Roll out a 21 CFR Part 11 solution quickly, with minimal training, leveraging the familiar Microsoft products you have already installed | | • | Maintain a low total cost of ownership by extending investments in Microsoft products | | • | Take advantage of a rich network of technology partners who are well-versed in Microsoft Office technologies and 21 CFR Part 11 implementations |
Microsoft Office System ProductsThe 2007 Microsoft Office system is an integrated set of products, technologies, and services that enable customers to increase their organizational, team, and personal productivity. A 21 CFR Part 11-compliant solution often uses these products and technologies: Microsoft Office SharePoint Server 2007 Microsoft Office Word 2007 Microsoft Office Excel 2007 Microsoft Office InfoPath 2007 |
