In today’s world of ubiquitous electronic technology, electronic data management has become crucial, particularly in regulated industries such as pharmaceuticals, power supplies and medical devices.
CFR 21 Part 11, issued by the US Food and Drug Administration (FDA), plays a key role in ensuring the integrity and traceability of electronic data in these sectors.
What does CFR 21 Part 11 mean for industry?
CFR 21 Part 11, is a regulation designed to establish strict standards for the use of electronic signatures and electronic records in FDA-regulated processes. Its main objective is to ensure that electronic data used in clinical trials, pharmaceutical, food and medical device production is reliable, secure and compliant with regulatory requirements.
Which industries are affected now and in the future?
Currently, CFR 21 Part 11 is mainly applied in the pharmaceutical, food and medical device industries. However, its influence is gradually spreading to other sectors, as more and more companies recognize the benefits of electronic data management to ensure quality and compliance. Compliance has become essential for pharmaceutical, cosmetics and food industries wishing to market their products not only in the USA, but also internationally.
What does this mean in industry, and more specifically in industrial production control equipment such as scales?
In industry, including industrial production control equipment such as scales, torquemeters, vacuum bells and statistical control measures, CFR 21 Part 11 requires the use of electronic signatures to authorize and authenticate critical operations. For example, when weighing pharmaceutical ingredients on an electronic scale, an operator can use an electronic signature to validate the accuracy of the measurement. This ensures that weighing data is reliable and tamper-proof.
Traceability, Data Logging and Audit Trail: Fundamental Understanding?
CFR 21 Part 11 places a strong emphasis on traceability, data logging and audit trail. It requires electronic systems to keep complete, unalterable records of all activities, including changes to data. This enables full traceability of all stages of the process, and facilitates regulatory inspections.
The audit trail records all actions performed on data, from creation to modification and approval. These functions reinforce transparency and accountability in electronic data management, crucial elements for compliance with CFR 21 Part 11.
How does ACRN meet these requirements?
ACRN meets the requirements of CFR 21 Part 11 with its new checking fixtures:
The Data Integrity option guarantees data preservation and protection, as well as traceability of actions carried out on the device.
ACRN has designed an intuitive, easy-to-use user interface, as well as an overview screen to quickly check that the device parameters guarantee Data Integrity compliance, in order to offer this option while maintaining simple, ergonomic machines.
What’s more, our systems feature customizable user profiles and automatic logout settings to ensure data security.
