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. 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, and easily lost content, along with process-based design documents and test results, et cetera, make up every project's natural work stream.
Using a keyboard with Microsoft Word and Excel is not much faster than using a typewriter with paper. Project managers still copy, paste and summarize what team members have already entered into emails and documents they prepared.
Menlo Park Project will be different. No copying or pasting is required. Team member comments will be entered into the one application using fields labeled "For the Record". These permanent postings will be automatically sent via email or texts to interested stakeholders and have a secure path into history files without chance of being lost.
Comments recorded in log entries will stay with the project forever. They will appear in generated documents. 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 will be a project management framework that integrates collaboration, report generation elements and risk management.
Data will be entered into the application to 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]".