Project natural work stream
Some of us still remember when the records library used shelves and paper. And, collaboration was done with typed memos and forms. Remember putting "CC: Librarian" at the bottom of memos? Our status reports, meeting agendas and minutes were also part of our projects' natural work streams.
21 CFR 820.30(j) Design history file declares
'... design history may include memoranda and electronic mail correspondence'.
So this natural collaboration, easily lost in email streams, with process-based design documents and test results, et cetera, make up every project's natural work stream.
Procedures will be coded into procedure template elements like goals, risks and constraints. When accepted into a project they will be translated into team member lists of tasks to perform and issues to resolve. Becoming flexible 'work guidance' instead of one-way 'work flow'.
Menlo Park Project will be different. No copying or pasting is required. Team member postings are entered into the application using "For the Record" fields. The results form a complete and accurate audit trail, having a date and time stamp, and limited access to approved personnel.
Comments recorded in log entries will stay with the project forever. They will appear in generated documents. You can select how far back into history reports should go.
99 years? Not a problem unless you send it to a printer.
Compliance tools add work
Large compliance tools are comprised of many forms to be filled out and a document control system to hold them. Read for yourself from a white paper by such a provider:
Menlo Park Project will be different. It is a project management framework that integrates collaboration, report generation and risk management.
Data entered into the application form the project's natural work stream. Team members will be alerted to changes and comments by email or text messaging etc.
The resulting collaboration and natural work stream will be recorded in thread postings. Generated reports will go into the history files in place of all those artificial forms.
Generated reports will reference process documents and provide the thread of evidence that "demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part [21 CFR 820]".