Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...
As electronic records become more common in pharmaceutical manufacturing, gaps in data integrity are surfacing - and regulators are watching.
As a result, employees waste a lot of time on processes that attempt to guarantee the authenticity of electronic records.
At a typical pharmaceutical company, shop floor operators can spend on average, 30 seconds typing their username and password, not to mention second attempts.