Last week I started a series on Good Manufacturing Practices (GMPs) within the dairy industry, specifically ice cream. Beyond the regulations outlined in CFR 21 Part 110, producers of dairy products must also adhere to the guidelines of Part 11, the expectations for collecting, storing and maintaining electronic records.
CFR 21 Part 11 was implemented in 1997, but as a response to various concerns of the business community, it has been in a period of reexamination since 2003. Regardless of what may occur or change in the near future, the components of Part 11 are still relevant and enforced, and its five core requirements are validation, audit trails, legacy systems, copies of records and record retention.
Validation: We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability and authenticity of required records and signatures.
Audit Trails: Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date, time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.
Legacy Systems: The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11.
Copies of Records: You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules.
Record Retention: The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period.
The fundamental purpose of part 11 plays an active role throughout the dairy production and distribution process. From pumping tubes to storage tanks to assembly lines to shipping containers to store shelves, dairy, whether frozen or not, passes through numerous stages of preparation and various pieces of equipment before reaching consumers’ hands, and one example of this highly involved supply chain is the procedure of pasteurization.
Pasteurization, named after scientist Louis Pasteur, is a process that removes pathogens by way of extremely intense heat, and though there are several levels of it, the range of applied temperatures is 145-280°F with exposure times starting at fractions of a second and ending at several minutes. Too often dairy products are subjected to poor pasteurization practices or compromised environments, and when such happens, like in these historic and recent cases, consumers fall ill, companies lose money, and FDA investigators start, well, doing their job.
Maintaining and monitoring imperative pasteurization thresholds and times is vital to the integrity of dairy products and dairy companies, and as noted, GMP regulations (CFR 21 Part 11) are in place to verify production processes and historical data. However, firms need not obsess over product and governmental mandates with the existence of proprietary and automated, cloud-based systems like Temperature@lert’s Cellular Edition and Sensor Cloud.
Meeting or even exceeding GMPs and the standards of CFR 21 Part 11 is easier than ever with features like backup battery power, actionable e-mail, phone, or text alerts, six-year data storage, and, should anything require attention, corrective action and audit trails. Temperature@alert’s solutions are more than just sensors and software; they are reliable and autonomous partners in asset protection and regulation compliance, and there’s nothing sour about that.
Chris Monaco, Covert Content Creator
As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.