The Importance of Audit Trails – 21 CFR Part 11

tablet hardness testersOver the past decade, pharma companies have been increasingly moving towards automation, electronic storage and streamlined processes. Within this trend, a necessity to record, store, transport and print from electronic data has led to more and more importance being placed on the integrity of that data being advocated.

Audit trials have become the answer to the problem, especially within areas requiring strict compliance, such as quality control and analytical development.

To put it simply (and within the context of analytical lab equipment), audit trials provide an electronic record of everything that happens to the machine in question. From the moment you switch on and login, everything is documented and stored. Times, dates, user accounts, activity and results of tests and additions and amendments to products and methods are all logged and secured for reference. This provides a clear, comprehensive trial of everything that happens to the equipment, as well as the processes leading to, during and after individual tests are completed as well.

Having audit trial capabilities enhances your company’s commitment to compliance and robust standards. It also allows for the secure and accurate logging of data, which if compliant with the FDA’s 21 CFR Part 11 specification, certifies your electronic records and storage as trustworthy, accurate, and equivalent to paper records. The 21 CFR Part 11 compliance standard is about as high as it gets, and is fast becoming the default audit trial benchmark.

Some of the recently released ERWEKA equipment can have the 21 CFR Part 11 audit trial capabilities built-in, providing you with the confidence that the data recording is integral and accurate. The MultiCheck, EasyCheck and ZT 720 are fine examples of this in action. Please contact us if you’d like to find out more about these pieces of lab equipment, we’re all too happy to help.