Organizational Change Management (OCM) for FDA Regulated Computer Systems

Course Description:

The key challenge for many users and others working to validation computer systems involves their ability, or lack thereof, to control data and information. If processes change such that users who had a part in the review and approval of data and/or information are no longer required to participate, they may feel insecure, both about how well data integrity, identity and accuracy is maintained, and about their own job stability. It is not uncommon for newer systems to take over the role of automatic matching or checking that was once done by a human. Once thoroughly tested, the process eliminates the potential for human error, while reducing the time and cost associated with it.

A key challenge to IT and other implementation and support personnel in Organizational Change Management is the degree to which they must participate in any validation effort. IT resources that are not typically involved in FDA-regulated systems may not have the training required to provide implementation or maintenance support. It is critical that if they are involved, they buy into the concept that they must do this work in a compliant manner, and that there is no room for short-cuts.

Management may also erect barriers to change. If they no longer have visibility into data/information, or if their data/information is now visible to others who previously could not see it, they will have some concerns. They must have a thorough understanding of the level of security applied and knowledge of exactly who has what type of access to it. In addition, while they may have received reports in the past, they may now be required to get this information directly from the system by logging in and running a query or report electronically. They will have to be assured that the data sources are the same, the integrity is maintained through reporting, and the reports are in real-time, meaning they are always up-to-date. If this is not the case, that also must be conveyed to them.

The Organizational Change Management goal is to communicate effectively the impact of change to users and others, and to allay any concerns they may have about the future. Identifying these is critical to avoid complaints and non-compliance later on. In extreme OCM cases, there could be sabotage, which could sideline any effort quickly and destroy the credibility of the team.

Why should you Attend?

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the changes that will impact the organization will be identified clearly and will be minimized to eliminate additional cost and wasted time.

There is an enormous body of documentation and information available that can be overwhelming. This Organizational Change Management course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

You should attend this Organizational Change Management seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system as changes are made.

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