Companies have been developing tailored approaches to making their individual Lotus Notes-based applications compliant with the regulation for as many as three years. Few companies have actually deployed an approach that the FDA would find acceptable; although they have spent millions of dollars so far developing approaches to modifying Lotus Notes-based applications to become compliant. Many CIOs and VPs of Regulatory Affairs have voiced the concern that even if they do achieve compliance with some of their applications, the methodology and program code is different in each deployment.

ComPac GxP from Winchester offers a simple, single, consistent approach that a company may use to make both the Lotus Notes environment and each application compliant with 21 CFR Part 11, for a very limited outlay of capital. And, they can be sure that their future applications begin and stay compliant from the day the first flowchart is drawn.

Your existing Lotus Notes applications can become compliant using ComPac GxP coupled with the proper operating procedures. After some limited training of your Lotus Notes development staff, they can place the components directly into the design of your existing applications in a "snap-in" fashion. Using the ComPac GxP Administration module, you can select how you wish to administer the passwords and audit trails. You can chose to create audit trails on all or selected forms and all or selected fields.

ComPac GxP has been tested with a wide variety of other applications to further extend its power to other critical functions within the organization including finance and operations. These include: word processing, spread sheets, management reporting, and other database managers.

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