GLP SOPs for equipment calibration and maintenance. Part 2: an organized approach to streamlining procedural documentation

As anyone who has had to deal with a Standard Operating Procedure (SOP) system can testify, managing these documents is a Herculean task, requiring full–time commitment. This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel. Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since there is a logical structure to delivered information; thus, users can control the level of detail based on their need. (5) Reduced effort for upkeep of individual documents. Copyright © 2006 John Wiley & Sons, Ltd.