The company that I work for carries out clinical research involving the processing of auto/allogeneic cell-based products for therapeutic purposes. Each project team is required to hold meetings at the start of each shift to go over what processing has to be done, what deviations need to be addressed from prior processing, and the implementation of any design changes. Design changes most frequently occur within the manufacturing/production protocols, such as adding/removing certain steps, rewording a procedure for simplicity, or simply correcting a typo.

The meetings we hold are more informal than formal in the sense that although all issues that are brought up get addressed, we do not necessarily record the context or the duration of the meeting under any official document. The probable reason for this is because the extra documentation is perceived as excessive and tedious due to the lack of an electronic QMS, which has yet to be developed because our products are still in the clinical phase of development. In a more formal setting however, a GDP-based document will be used to indicate the meeting name, purpose, attendees, the number of tasks on the agenda and who is scheduled to carry out each task as well as a signature section for all of the attendees to confirm that they acknowledge the content of the meeting.

Some meetings may take place via skype or over the phone due to its participants being in different locations, which can complicate the use of formal documents. Should a regulatory document be required for each meeting of a design/development process if the product being worked on is a tongue depressor? What about for an implantable pacemaker?