Astell updates autoclave controller to provide in FDA 21 CFR Part 11 auditing on demand.
28 Jan 2020
Astell Scientific is introducing the latest release of its controller software, allowing password protected FDA 21 CFR Part 11 logs to be accessed instantly
FDA 21 CFR Part 11 requires all computerised hardware used for regulatory purposes to provide reliable digital records, with electronic signatures that are as trustworthy as handwritten signatures on paper-based records.
While the software is aimed chiefly at the medical and pharmaceutical manufacturing industries, the update enables continuing legislative compliance and traceability support that can benefit many industries requiring sterilisers.
Deployed across both the square and circular section autoclaves, the software generates records of all changes performed on the device and, through user login, attributes them to an individual. By allowing these secure records to be accessed on-demand, the update provisions for spot-checks on system use.
Astell Sales and Marketing Director, Paul Birchmore, said: “The continued updates to Astell’s autoclave control software brings our customers enhanced monitoring and record management, allowing them to go above and beyond industry regulations. This shows why Astell Scientific remain the leaders in sterilisation.”