Yes, a workflow, such as creation of an electronic master production and control record
(MPCR), is an intended use of a computer system to be checked through validation (see
§§ 211.63, 211.68(b), and 211.110(a)). If you validate the computer system, but you do
not validate it for its intended use, you cannot know if your workflow runs correctly. For
example, qualifying the Manufacturing Execution System (MES) platform, a computer
system, ensures that it meets specifications; however, it does not demonstrate that a given
MPCR generated by the MES contains the correct calculations. In this example,
validating the workflow ensures that the intended steps, specifications, and calculations
in the MPCR are accurate. This is similar to reviewing a paper MPCR and ensuring all
supporting procedures are in place before the MPCR is implemented in production (see
§§ 211.100, 211.186, and 212.50(b), and the guidance for industry PET Drugs — Current
Good Manufacturing Practice (CGMP)).
FDA recommends you implement appropriate controls to manage risks associated with
each element of the system. Controls that are appropriately designed to validate a system
for its intended use address software, hardware, personnel, and documentation.