Data Integrity is the current focus of regulatory authorities across the globe. There have been high profile cases recently which have highlighted weakness in the integrity of data that can be modified, destroyed or lost due to ineffective processes.
It is critical that Quality, in the regulated manufacturing environment has addressed all of the processes and particularly when legacy standalone instruments are used in an SOP. Each step needs an effective audit trail making any data manipulation by a user impossible.
PAX-it!’s Extended Security module combined with the PAX-cam camera for microscopes, can provide a fully comprehensive compliance software that features unique logins, detailed audit trails and electronic signatures that can prevent any problems regarding data manipulation, this software is fully compliant with the FDA regulation 21 CFR Part 11.
PAX-it is very successful and has a proven track record in the United States and around the world as the leading software for data protection and prevention from data manipulation in the area of microscopy.
Mason Technology have found three types of legacy microscope configurations in the market that are not compliant based on guidelines on data integrity by US, European and UK regulatory bodies.
The first system, is the manual microscope in the laboratory which is no longer acceptable. A microscope can no longer be a standalone instrument used by an analyst to make decisions based on a paper bases SOP. This process has no tractability or repeatability.
The second system, is based on a microscope with a stand-alone camera that can print images without the need to be saved. This procedure is no longer compliant as it is a hybrid system and the auditor will look for this to be replaced with an electronic paperless system.
The third system, is a complete software solution that has the functionality required to save the images and analysis the images but does not comply with regulations regarding Audit trails, electronic signatures or user login requirements.
Mason Technology has teamed up with PAX-it! to offer a turn-key solution for laboratories to become fully compliant. Mason Technology exclusive rights to supply PAX-it! in the UK and Irish market.
For over 25 years, the intuitive PAX-it! software has provided image analysis and management tools which allow you to measure and annotate images, create custom reports, and store digital assets in a secure database. Now PAX-it! has added additional layers of protection to ensure you meet the high security standards set by the FDA.
With this software, being compliant for Data Integrity will not be an issue. Reports can be locked for viewing in PAX-it! or can be locked for editing and authenticated using the PAX-it!’s Extended Security module. PAX-it! can address all of your imaging needs.
Click the HERE for more information regarding the PAX-it software and its extended security features.