All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.
Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences.
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