We live in a digital world, with technology fundamentally integrated into our business processes and how we work. Digital systems lay the foundation for businesses to standardize, and increase productivity and efficiency.
21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. This Electronic Records and Electronic Signatures regulation was published in 1997 and still acts as the FDA's standard for considering electronic records and signature to be reliable, establishing a baseline to equate electronic and paper records and signatures.
Because "electronic submissions for FDA approval of new products are faster than paper submissions", most companies seeking FDA approval opt for electronic submission to get products on the market sooner. This means that 21 CFR Part 11 is relevant to any companies seeking FDA approvals, especially to life sciences companies trying to sell products and services in the United States. 21 CFR Part 11 compliance applies to any "systems used in researching, manufacturing, and distributing product such as pharmaceuticals, medical devices, biological products (e.g. vaccines), blood, and tissue (e.g. organ transplants)". (Validation Center)
RheoSense VROC initium one plus automated viscometer software has always been 21 CFR Part 11 compliant. The m-VROC® viscometer is the leading small sample viscometer, featuring the widest dynamic range (high shear rate viscosity measurements up to 1,400,000 s-1). The m-VROC software allows you to easily save and load your protocols, perform shear rate and temperature sweeps, export data into PDF/Excel, and applies non-Newtonian correction with the push of a button. The m-VROC 18.104.22.168 software is now also 21 CFR part 11 compliant, providing multi-level user access. These additional features provide different access levels for your users (standard user, IT admin, super admin etc.) and ensure data integrity, preventing users from potentially manipulating your data.
If you are one of the thousands of companies working toward FDA approval, or if you are looking to get away from paper records and signatures you must comply with 21 CFR Part 11.
Are you ready to upgrade your m-VROC software to the new 21 CFR Part 11 compliant version? Contact us for more details about the updated software capabilities and pricing!
Written by: Eden Reid, RheoSense Senior Marketing and Sales Operations