FDA Regulation 21 CFR Part 11: What is it?

Discover our Top Line autoclaves: designed to operate under FDA, GMP, and GLP environments

The 21 CFR Part 11 Regulation was established by the FDA in 1997 with the primary purpose of promoting the use of electronic technology as a substitute for paper in the recording processes. This regulation is especially relevant and mandatory in the Pharmaceutical Sector and Life Sciences. By encouraging the adoption of electronic records and signatures, not only is greater speed and ease achieved in these processes, but also better management, facilitating the storage, processing, and reliable retrieval of data. One of the core objectives of this regulation is to ensure data integrity. This means it aims to ensure that information contained in electronic records is as reliable and has the same value as records and signatures made on paper.

For companies and entities seeking to adhere to this standard, our Top Line autoclaves are the key; exceptional tools that offer total control, advanced technical support, and professional traceability, equipped with the most advanced connectivity on the market and designed to operate in FDA, GMP, and GLP environments typical of the pharmaceutical and biotechnology industry.

Ensure your company's compliance with Regulation 21 CFR Part 11 and position your technology at the forefront with Top Line autoclaves.