|
|
NEWS 21CFR11 COMPLIANT SOFTWARE FOR LYOSTAT2 BTL has responded to the FDA’s guidelines on electronic signatures and ‘operator access control’ to software-controlled equipment, by providing a new 21CFR11-compliant version of the Lyostat2 ‘integrated image capture and temperature/pressure control’ software. In addition, we have recognised the apparently increasing need for Installation Qualification (IQ) and Operational Qualification (OQ) by some of our customers, for instruments which generate experimental data that are subsequently used to determine production parameters. This has prompted us to add the further options of IQ and OQ for Lyostat2, where BTL can prepare (or assist in the preparation of) the documentation which can be tailor-made to customer requirements, as well as carrying out the IQ and OQ testing after delivery. One BTL customer just outside Paris (France not Texas
this time!) has already taken advantage of both the software and the IQ/OQ
options, with our Dr Ward completing the installation and training programme
for their Lyostat2 and getting the users up and running. If you are interested
in any (or all!) of these options, please contact us to let us know your
requirements.
|
|
|