An online exerpt1 states the goals of change control as follows:
o Minimal Disruption to Services
o Reduction in "Back-Out" Activities
o Economic Utilization of Resources Involved in Implementing Change
These goals though ideal are not always the final results for life science and high tech (e.g. engineering) companies who implement change control procedures. In fact, change control processes are often implemented at relatively slow pace and are often disjointed due to paper-based and/or hybrid systems of management. Software solutions that streamline or manage change control processes can also be extremely pricy so it's important (if a company wants to move to an automated system of change control management) to search for a solution that makes sense. This article provides information for life science and high tech companies looking for a software solution that will help streamline and implement change control processes with more speed, simplicity and attention to the three goals listed above.
Speed
Speed is essential for effective change control process achievement. A pharmaceutical company for instance may have a product-to-market delay of 30 days, which may not initially seem severe or detrimental. When one considers however that a pharmaceutical company stands to lose around a million dollars per day when products are delayed the situation is greatly aggravated.
This software along with additional quality system software solutions can change the speed at which a life science or high tech product reaches the market. The right software for example can increase the speed of related processes by connecting employees from various departments with the data and documentation controlled in a single, centralized web-based system. The right software solution can also speed processes by automating task assignments, the routing tasks, the notification of employees and escalations when tasks remain incomplete. Another valuable feature is one that allows the quick electronic entry of data on electronic forms that are created according to best practices for change control management. Reporting features are also essential as a feature to the solution since data that remains unreadable or shy of analysis is data that doesn't become a part of the important decisions that these should influence.
Simplicity
The simplicity of a solution like this is greatly increased when the solution is connected with other quality related solutions. For example, this solution that can automatically and electronically be triggered by customer complaints, deviation, nonconformance, audit or CAPA solutions, then managing an entire quality system suddenly becomes a lot less complex. This should also be able to trigger training tasks when necessary.
Goals
The three goals listed above should be met as follows:
o Minimal Disruption to Services- For some companies, this goal might read "Minimal Disruption to Products" and can be achieved in part by making sure that employees are well versed (i.e. trained) on change control procedures and new documentation altered according to change control orders. Training doesn't have to greatly disrupt a company environment. A web-based training solution should simply be configured with the change control solution so that orders may automatically trigger training tasks that will be emailed to specified employees.
o Reduction in "Back-Out" Activities--- No company wants to deal with product recalls but that is exactly what happens when this data is not readily readable and quickly available for analysis. Companies should look for a solution that provides electronic tracking for easily analyzed audit trails that mark the progression of data, documentation and employees.
o Economic Utilization of Resources Involved in Implementing Change--- With the right solution, companies are going to pay a significant price but in the end most companies should make significantly large profits with the aid of the right solution. Pharmaceutical companies for example can save millions and easily receive a quick ROI.
Conclusion
It appears that for life science and high tech companies it's hard to go wrong with a software solution that provides the features and benefits mentioned above.
1wikipedia.org/wiki/Change_control
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To read content regarding change control and additional quality management systems, please feel free to contact a MasterControl representative.
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