21 CFR Part 11
A com plete risk based service from Auditing existing systems to making sure that
everything possible is done to secure data.
We can protect legacy software by using a software wrapper to make the software
compliant with 21CFR. We have done this already for UVWinlab from Perkin
Elmer.
The UVWinlab software for Perkin Elmer spectrometers has been protected by moving it to a Windows NT environment and securing the desktop. The system is stand alone and allows data to be backed up and archived to CD on the Dell Optiplex PC. The wrapper can be ordered from Perkin Elmer or by contacting Smart Tech.( bob@smarttech-ww.co.uk).
Automation
Automation of business processes and laboratory/process systems.
Installation
The company has a wide experience of installing systems, from servers to full laboratory computer systems (e.g. Chromatography Data Systems)
Process redesign
Use of iterative modern techniques within a regulated environment to FDA and other regulatory standards.
Training
A broad range of management and IT related topics are available
Software Validation
A comprehensive service from definition of requirements to system implementation and life cycle management following GAMP 4.
Web design
We can design, host and manage your site to produce the results you require.