Equipment management is an essential part of product manufacturing. For companies developing regulated products, everything that happens to equipment (cleaning, calibration, maintenance, repairs, and usage) must be appropriately documented to maintain compliance with current good manufacturing practices (cGMP). Equipment activities are commonly entered in a large, bound manufacturing logbook.
All manufacturers are required to maintain logbooks and routinely review them for accuracy, clarity, and completeness. 21 CFR Part 211.82 cites that “A written record of major equipment cleaning, maintenance, and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed.” The written records must also follow the guidelines for data integrity.1
Logbook tasks are cumbersome and time-consuming. Any number of issues can occur with a paper-based manufacturing logbook - which can lead to costly delays. In March of 2021, the U.S. Food and Drug Administration (FDA) issued a warning letter to a pharmaceutical manufacturer for violations of current good manufacturing practices (cGMP). One infraction applied specifically to the company’s equipment logs saying, “You did not provide recent calibration information for your equipment, including the scales used to weigh active drug ingredients in the manufacture of your drug products.”2
Despite the availability of logbook software, many companies are still using paper for this process.
“In a recent review of a washroom at a biotech facility, I noticed that for five pieces of equipment, there were over 25 SOPs (standard operating procedures), forms, and logbooks that the operator needed to manage daily,” said a digital transformation manager at a major drug manufacturer. “The shelves were covered with logbooks to manage the paper. This is not optimal for the operators to get their job done.”
Paper logbooks are prone to omissions, mishaps, and other counter-productive issues, including:
“It’s wasteful and very time-consuming to have to review and regenerate 20 or 30 logbooks for one simple change,” said a manufacturing technical writer at a large pharmaceutical manufacturer.
Digitized logbooks alleviate the headaches the come with logging equipment activities. As another campaign in the war on paper, digitized logbook software can provide:
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