Software Compliance Systems
Mason Technology has seen a large increase in awareness with Data Integrity and the need to make any microscope in the Quality Control laboratories complaint. The most critical reason this has come to light is largely in part to the FDA regulation 21 CFR Part 11. This addresses most of the “current” requirements for the control and protection of data captured. When using a software system, electronic records, electronic signatures and preventing data manipulation is the main part to this regulation. The PAX-it! software is the leading supplier of compliance software for microscopy as it uses the security of SQL (Structured Query Language) database to secure the Metadata.
We found that many of Mason Technology’s customers were requesting a software that can prevent the manipulation of images, have an audit trail and provide electronic signatures. That is when Mason Technology decided to collaborate with PAX-it! to become their sole distributer for Ireland and the UK marketplace. PAX-it! has assisted a large number of multinational Pharmaceutical companies in Ireland. We realised there are other sectors that can benefit from this software such as the forensic science community, medical device industries, biotechnology industries along with many other manufacturing and scientific sectors. Mason Technology has a team of experts that supply a wide range of other microscopy products.
Mason Technology have now supplied a number of systems throughout the Irish market. The microscope is automated so that methods can be defined and saved for consistency and repeatability and complete samples tested by the software. For example, inspection of API’s the sample is presented to the microscope stage. The stage moves to a number of positions on the sample, captures the image, performs image analysis and produces a report showing the results. This removes the hours of work required by an analyst to do the same job and also increases reliability and consistency while also removing the paper trail from the process.
PAX-it! is a module based software which can be supplied with their extended security module, this module was developed to address the needs of companies requiring a compliance solution for the FDA 21 CFR Part 11 regulation and can provide a solution to companies who are looking to have a more secure system.
Ireland having the strictest regulations in the world, PAX-it! had to further develop it’s software to address certain areas in the Data Integrity and management section. Thus, the tab “ Reasons” came about in the pass/fail section. Multiple levels of digital signatures have been implemented, so that a second signature can be made at a user-level therefore the second signature did not require administrator privileges.
21 CFR Part 11 is only part of the story when it comes to Data Integrity. We come across 3 types of non-compliant systems based on the latest recommendations issued by all the regulatory bodies.
The first, is the basic microscope that is used by the laboratory analyst as part of a product sign off. This uses a paper based system or manual system to record an analyst interpretation of an image. There is no consistency between analysts and results can vary due to tiredness etc.
The second, system is the hybrid system an image is taken and kept in a printed form with the paper document to look back on in case of a query, this was a safe option up to recently.
The third, which is non-compliant under current regulations is the non-compliant software solution. This relies on the IT Department setting up an SOP to address non-compliant issues. This is not ideal as there are always ways in to change or modify data and therefore not compliant.