Innovatum has built several large scale, multi-site systems for pharmaceutical manufacturers. Each of these systems was fully validated and built in compliance with the FDA's 21 CFR Part 11 ruling. In addition, we assisted one large pharmaceutical company with a full validation of their existing ERP package, BPCS. Our personnel has years of in-depth, hands-on experience with all areas of systems validation, from designing and writing protocols (IQ, OQ, and PQ), to developing and executing test plans and cases.

Two of the more recent projects we have assisted our clients with are described below:

• Company 1 is replacing legacy applications. Some of those will remain in place for some months to come. In order for those business-critical applications to continue operating until a replacement is implemented, they will need to be interfaced to other new systems. Because they are related to manufacturing, all of the new systems as well as interfaces to existing applications will need to be fully tested and validated. Innovatum's unique blend of technical, pharmaceutical manufacturing, and computer systems validation in a regulated environment, will provide valuable resources in this effort.
• Company 2 is operating several electronic systems in a manufacturing and distribution environment. The company has a corporate goal to achieve 21CFR Part 11 compliance within a reasonable yet aggressive time frame. Once again, Innovatum personnel can fill the gap with resources who understand, in detail, the regulation. They also have built and implemented Part 11-compliant systems. Innovatum will assist this company in building an achievable plan to reach their compliance goals.

If your company needs validation of new or existing systems or is in the process of analyzing remediation options, we are here to help. We've been there, and can offer guidance at any level you might require. Call us today and let us be part of your validation team.