ABSTRACT
The Shorter Oxford English Dictionary1 defines the word “document” as “that which serves to show or prove something.” In the pharmaceutical industry, the unavoidable need to “show or prove something” ensures that documentation is an essential component of critical business processes and activities. Within pharmaceutical manufacturing, examples of documentation required by GxP regulations include master production records, batch records, standard operating procedures, validation documentation, analytical test procedures and results, cleaning logs, calibration records, etc.
