Document ID: DQ278 Relevant to following products: WorkOut 2.0 Document description: Is WorkOut 2.0 21CFR part 11 Compliant?
It is not the software’s responsibility to achieve compliance, it is the labs’. WorkOut is only one part of the process but it can be used in these environments as part of the process.
At this time, we do not feel that it is reasonable for our data reduction software to impose an interpretation of the 21CFR11 rules. Much like Excel is not itself 21CFR Part 11 compliant, it can be used in such an environment when working to an organisations’ SOPs and interpretation of the guidelines.
We are aware of a number of users working with our software in a 21CFR Part 11 compliant environment. For example, this can be achieved using the VICTOR or EnVision in 21CFR11 mode with WorkOut being used solely as a data reduction package. In another scenario, WorkOut can be used in the online mode with all data stored in a 21CFR11 secure area or server.
In the real world, a number of software packages are used together controlling a variety of instrumentation and all must operate under the same rules throughout an organisation. It is often the case that different product vendors and end users have their own conflicting interpretation of the rules. Running different packages with different interpretations, requirements and disparate implementations together is a counterproductive solution. For example, requiring the user to log in to separate software components administrated by separate user databases is an unwieldy inconvenience for users and administrators.
The underlying requirements of the rules are clear and can be easily applied to all types of electronic data. It is our opinion that all compliance rules should be handled by one centralised system specialising in this need to minimise the administrative burden.
Thus, we recommend the use of a 3rd party product for providing a secure data area for all data that must be stored under the 21CFR11 requirements. These 3rd party solutions provide the logical scalable solution and are already in use in major pharmaceutical companies.
We are happy to recommend such products and work with customers in integrating WorkOut into their centralised 21CFR11 management system. Please use the technical contact form for more information.