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Change Control Protocols
Changes to software and hardware systems in a regulated environment must be carefully evaluated, verified, documented and reviewed.
Fast Trak Validation™ provides Change Control Protocols (CCP) for:
- UNICORN™ upgrades
- Other system modifications
The CCP is not a full Installation and Operational Qualification, but contains the documentation necessary to return a system or other equipment to a validated state after changes have been made. There are sections within the CCP to document the reasons for the change and how the change was made. After changes have been made it is necessary to verify that the system operates as before, that signals are sent and received correctly, and that process-unique methods operate as specified. Consequently, the CCP package has three main sections: documentation of the system before the upgrade; documentation of all modifications made to the system; and documentation of testing of the system to verify correct function.
There are fixed code numbers and prices for UNICORN upgrades. Other system modifications require individual quotes based on the document's complexity and the extent to which the modification affects the system.
Fast Trak Validation can also assist you in making modifications to meet your document standard and/or validation philosophy.
The documents are delivered as hard copy in a binder and as a protected Microsoft™ Word file on a CD-ROM. |
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