An online exerpt1
states the goals of change control as follows:
·
Minimal
Disruption to Services
·
Reduction in
“Back-Out” Activities
·
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.
processes by connecting employees from various departments with the change control data and documentation controlled in a single, centralized web-based system. The right software solution can also speed change control processes by automating task assignments, the routing tasks, the notification of employees and escalations when tasks remain incomplete. Another valuable change control feature is one that allows the quick electronic entry of change control 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 change control solution since data that remains unreadable or shy of analysis is data that doesn’t become a part of the important decisions that change control should influence.
Simplicity
The simplicity of a change
control solution is greatly increased when the solution is connected with other
quality related solutions. For example,
a change control 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. A
change control solution should also be able to trigger training tasks when
necessary.
Goals for Change Control
The three goals for change
control should be met as follows:
·
be configured
with the change control solution so that change control orders may
automatically trigger training tasks that will be emailed to specified
employees.
·
Reduction in “Back-Out” Activities---No company wants to deal with product recalls but that
is exactly what happens when change control data is not readily readable and
quickly available for analysis.
Companies should look for a change control solution that provides
electronic tracking for easily analyzed audit trails that mark the progression
of change control data, documentation and change control employees.
·
Economic Utilization of Resources Involved in
Implementing Change---With the right
change control 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 change control
software solution that provides the features and benefits mentioned above.
Marci Crane
is a copywriter for MasterControl in