Will you be prepared when required to write a standard operating procedure (SOP), Batch Production Record (BPR) or Device History Record (DHR)? Writing these controlled documents in a way that will allow anyone to be able to read the instructions and execute the activities without error or run to run variation and provide the required objective evidence that each step in the execution of the instructions was conducted as required and the data recorded immediately. The purpose of these controlled documents is to ensure accuracy and repeatability when executing a task which is needed to demonstrate a successful quality system. When poorly written, these documents are of limited value. Using the following 10 guidelines, you can create a successful SOP document as well as batch production records and device history records (BPRs and DHRs). Following the recommended steps in the generation of controlled documents within the framework of the company’s policies, practices, and guidelines, the procedural related documents we have just discussed will help document authors deliver more accurate documents, with shorter review cycles and the elimination of operator errors.
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