Automated QSR Change Control for Medical Device Professionals in Regulated Environments
Marci L. Crane
April 05, 2008
QSR change control, or change control processes based on the FDA´s QSR regulation (21 CFR Part 820) is the ideal (or at least currently ideal) template for successful change control in the regulated medical device environment. Many medical device companies however may not realize that QSR change control can now be automated. In fact, it is not only the many processes of QSR change control that can be automated but the documentation and training associated with change control processes that can also be automated (and more effectively managed) for greater change control success.
This article is designed to focus on requirements stipulated by the QSR regulation and the software requirements that medical device professionals should look for to achieve best results.
DMRs Management
According to the FDA and QSR regulations, "Changes to DMR documents (i.e. device master records) shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval unless there is a specific designation that states otherwise. These approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include:
a description of the change,
identification of the affected documents,
the signature of the approving individual(s),
the approval date, and
when the change becomes effective [820.40(b)]."1
Solution Requirements for Automated DMR Management
In order to automate DMR management processes like those mentioned on the FDA website, medical device professionals should search for a solution(s) that automatically routes DMRs along pre-approved approval pathways and that protects the DMRs and DMR versions from being viewed by users who are not approved to do so. The solution(s) should also update specified personnel quickly when DMR changes have been made. The solution(s) would ideally track all DMR versions and DMR changes from start to finish, leaving a easily legible audit trail and would provide best practice change control forms that allow users to easily insert information into change description, identification, signature, date and effective date fields. Ideally the solution(s) should provide all of these features for any essential document and/or form.
Timing and Examination
The FDA also states that "The written change control procedure should describe the company ¬approved procedures to be followed from the time parts of the device master record are first released for production through examination of a change in relation to other appropriate documents, activities, and implementation."2 These FDA stipulations help to control the changes that will occur in the future by providing controlled evidence of change function and/or dysfunction.
Solution Requirements for Better Timing and Examination
These processes can to a great degree also be automated with the right software solution(s). For example, medical device professionals should search for a solution(s) that will allow them to control a document and release it upon the release of another document such as DMR for instance. The solution(s) should also allow users to effectively link to the documents, activities or implementations with which a change control may be associated. Deviation and non-conformance observances and trending reports regarding deviations and nonconformance events should also be at least partially automated.
Policy and Procedure Observance
Since the FDA also states that "The important point to consider is that all changes are made according to the approved company policy and procedure,"3 it is of course essential that medical device professionals consistently review both change control processes and their conformance to documented policies and procedures.
Solution Requirements
It is often difficult to remember when policies and procedures were last reviewed in the context of change control conformance. For this reason, it is important for medical device professionals to purchase a solution(s) that can be set up to update users at periodic intervals regarding scheduled policy and procedure reviews. This simple feature can help users observe policy and procedure deviations more efficiently and get both quality and compliance processes back in check.
Conclusion
To achieve regular QSR change control conformance and to stay competitive, medical device professionals should consider the solution requirements that will help automate and streamline their own production and compliance processes.
1-3 fda.gov/cdrh/qsr/09docnt.html
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control software, please feel free to contact a MasterControl representative.
This article is designed to focus on requirements stipulated by the QSR regulation and the software requirements that medical device professionals should look for to achieve best results.
DMRs Management
According to the FDA and QSR regulations, "Changes to DMR documents (i.e. device master records) shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval unless there is a specific designation that states otherwise. These approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include:
a description of the change,
identification of the affected documents,
the signature of the approving individual(s),
the approval date, and
when the change becomes effective [820.40(b)]."1
Solution Requirements for Automated DMR Management
In order to automate DMR management processes like those mentioned on the FDA website, medical device professionals should search for a solution(s) that automatically routes DMRs along pre-approved approval pathways and that protects the DMRs and DMR versions from being viewed by users who are not approved to do so. The solution(s) should also update specified personnel quickly when DMR changes have been made. The solution(s) would ideally track all DMR versions and DMR changes from start to finish, leaving a easily legible audit trail and would provide best practice change control forms that allow users to easily insert information into change description, identification, signature, date and effective date fields. Ideally the solution(s) should provide all of these features for any essential document and/or form.
Timing and Examination
The FDA also states that "The written change control procedure should describe the company ¬approved procedures to be followed from the time parts of the device master record are first released for production through examination of a change in relation to other appropriate documents, activities, and implementation."2 These FDA stipulations help to control the changes that will occur in the future by providing controlled evidence of change function and/or dysfunction.
Solution Requirements for Better Timing and Examination
These processes can to a great degree also be automated with the right software solution(s). For example, medical device professionals should search for a solution(s) that will allow them to control a document and release it upon the release of another document such as DMR for instance. The solution(s) should also allow users to effectively link to the documents, activities or implementations with which a change control may be associated. Deviation and non-conformance observances and trending reports regarding deviations and nonconformance events should also be at least partially automated.
Policy and Procedure Observance
Since the FDA also states that "The important point to consider is that all changes are made according to the approved company policy and procedure,"3 it is of course essential that medical device professionals consistently review both change control processes and their conformance to documented policies and procedures.
Solution Requirements
It is often difficult to remember when policies and procedures were last reviewed in the context of change control conformance. For this reason, it is important for medical device professionals to purchase a solution(s) that can be set up to update users at periodic intervals regarding scheduled policy and procedure reviews. This simple feature can help users observe policy and procedure deviations more efficiently and get both quality and compliance processes back in check.
Conclusion
To achieve regular QSR change control conformance and to stay competitive, medical device professionals should consider the solution requirements that will help automate and streamline their own production and compliance processes.
1-3 fda.gov/cdrh/qsr/09docnt.html
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to change control software, please feel free to contact a MasterControl representative.
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