6 Benefits of Electronic Change Control in Regulated Life Science Environments
Marci L. Crane
April 25, 2008
If pharmaceutical, medical device, research laboratories, clinical laboratories and other life science organizations have the available revenue, they should consider the benefits of change control automation. Automating many change control processes requires an electronic change control solution which can siphon significant amounts of company revenue but can also (if the solution capable) provide a return on investment in months. What do life science companies have to lose?
The truth is that life science companies have a LOT to lose if they don´t consider change control automation.
A good electronic change control system should, at the very least, provide the 6 following features:
Feature #1: The Automation of Change Control Requests and Other Related Change Control Forms
When those personnel members approved to make change control requests can do so by simply filling out an electronic form that is subsequently routed to specified approvers who receive updates in their preferred email client´s inbox, life science professionals have something to be happy about. The solution shouldn´t stop there however. The change control request form should also be tracked from start to finish and tasks such as change control follow-ups and escalations should also be readily configured and automated according to the particular life science company´s needs. The potential risk of a change should also be readily identifiable somewhere on the form.
Feature #2: Easy Search and Easy Access of Change Control Information
One of the main difficulties of managing change control procedures is managing the forms associated with change control requests and subsequent change control procedures. An electronic change control solution should eliminate this issue completely. For example, when a change control process is officially closed, all of the information associated with that change control request should be automatically archived in a centralized location making the change control information far easier to search and locate than it would have been in its paper format. It is also recommended that the solution chosen for change control management be web-based since web-based applications allow users to access the system from virtually anywhere.
Feature #3: Document Control, Collaboration and Change Control Capabilities
Document control and collaboration solutions that can actually be launched from the same platform as a change control solution are valuable because the solutions do not have to be launched, integrated, supported and validated by separate entities. In addition to being combined in the same system, document control and collaboration solutions should also track documents, provide version control, automate routing processes and provide a centralized collaboration space (while still allowing users to continue using the work tools they are familiar with to change and edit documents) where redlines will be recognized and reporting/analytics features.
Feature #4: Training Control
Since an approved change is almost inseparably connected with training, the entire system solution should also allow for a training solution to be launched from the same platform. The training solution should keep track of training projects and should also integrate with document change control procedures. It should do this by being triggered by the document control solution when specific documents (such as SOPs for example) have been changed.
Feature #5: CAPA
Since change control measures can result in situations that require corrective and preventative action controls, it is also useful if the solution in question provides a CAPA solution that can be launched from the same platform. Yes! You are getting the idea. Any type of technical quality or compliance solution should be able to be launched from a single platform.
Feature #6: Validation Aids
A software solution without validation aids and solutions provided by the software vendor today is like cookies without milk. Validation aids and solutions can significantly decrease the time and money required for software validation.
Conclusion
A recent FDA article, Change Control: Best Practices For FDA-Compliant Medical Device Manufacturers states that, "Any organization that has either the volume or the revenues to be able to use a computerized system should definitely do so." The statement of course is only a recommendation but the entire life science industry is leaning towards digital control and when solutions are available that provide ROI after only months or a few short years, what do life science companies have to lose?
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control management software solutions, please feel free to contact a MasterControl representative.
The truth is that life science companies have a LOT to lose if they don´t consider change control automation.
A good electronic change control system should, at the very least, provide the 6 following features:
Feature #1: The Automation of Change Control Requests and Other Related Change Control Forms
When those personnel members approved to make change control requests can do so by simply filling out an electronic form that is subsequently routed to specified approvers who receive updates in their preferred email client´s inbox, life science professionals have something to be happy about. The solution shouldn´t stop there however. The change control request form should also be tracked from start to finish and tasks such as change control follow-ups and escalations should also be readily configured and automated according to the particular life science company´s needs. The potential risk of a change should also be readily identifiable somewhere on the form.
Feature #2: Easy Search and Easy Access of Change Control Information
One of the main difficulties of managing change control procedures is managing the forms associated with change control requests and subsequent change control procedures. An electronic change control solution should eliminate this issue completely. For example, when a change control process is officially closed, all of the information associated with that change control request should be automatically archived in a centralized location making the change control information far easier to search and locate than it would have been in its paper format. It is also recommended that the solution chosen for change control management be web-based since web-based applications allow users to access the system from virtually anywhere.
Feature #3: Document Control, Collaboration and Change Control Capabilities
Document control and collaboration solutions that can actually be launched from the same platform as a change control solution are valuable because the solutions do not have to be launched, integrated, supported and validated by separate entities. In addition to being combined in the same system, document control and collaboration solutions should also track documents, provide version control, automate routing processes and provide a centralized collaboration space (while still allowing users to continue using the work tools they are familiar with to change and edit documents) where redlines will be recognized and reporting/analytics features.
Feature #4: Training Control
Since an approved change is almost inseparably connected with training, the entire system solution should also allow for a training solution to be launched from the same platform. The training solution should keep track of training projects and should also integrate with document change control procedures. It should do this by being triggered by the document control solution when specific documents (such as SOPs for example) have been changed.
Feature #5: CAPA
Since change control measures can result in situations that require corrective and preventative action controls, it is also useful if the solution in question provides a CAPA solution that can be launched from the same platform. Yes! You are getting the idea. Any type of technical quality or compliance solution should be able to be launched from a single platform.
Feature #6: Validation Aids
A software solution without validation aids and solutions provided by the software vendor today is like cookies without milk. Validation aids and solutions can significantly decrease the time and money required for software validation.
Conclusion
A recent FDA article, Change Control: Best Practices For FDA-Compliant Medical Device Manufacturers states that, "Any organization that has either the volume or the revenues to be able to use a computerized system should definitely do so." The statement of course is only a recommendation but the entire life science industry is leaning towards digital control and when solutions are available that provide ROI after only months or a few short years, what do life science companies have to lose?
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control management software solutions, please feel free to contact a MasterControl representative.
Print
Email
