Guidelines from all the regulatory bodies have either been amended or are in the process of amending their positions. Recent publication of the GAMP Guide: Records and Data Integrity was published in April 2017 while the ECA is expected to release their 2nd Data Governance and data Integrity for GMP Environments in 2017. PDA are also expected to release Data Integrity for laboratory Data in 2017.
In addition to the focus on Data integrity guidance a new USP 1058 has been released surrounding the Integrating Analytical Instrument (AIQ) Qualification and Computerised System Validation (CSV). This USP is focusing on the process around assessing an instrument from requirement, risk, specification, operation, performance up to retirement of the instrument.
Mason Technology offer the client consultation to assess their requirement in relation to the test that is required and can build a specification to fit the requirement while automating the process within the guidelines for Data integrity. The software will remove the paper trail and migrate hybrid camera based microscopes to compliant solutions for API testing, Microbiology or Cell Culture viability.
PAX-it! is a US manufactured software that is supplied into the Pharmaceutical industry with their 21 CFR Part 11 extended security module. This addresses the regulations concerning the collection and storage of electronic records and electronic signatures. Data Integrity is critical in a Pharmaceutical Quality System, with auditors enforcing compliance. Audit inspections now include observations of manual and Hybrid systems and there has been a well published increased in the number of Data Integrity citations in the Healthcare and Pharmaceutical Industries. The Auditor will check electronic records for “accessibility, durability, and accuracy” over the lifetime of the records.
Mason Technology uses its experience to assist with 21 CFR Part 11 compliance for your microscope applications and will offer guidance surrounding Data Integrity. Mason Technology partner with the best brands and suppliers. We have built a partnership with PAX-it! to provide their industry-leading software to the UK and Irish market. The 21 CFR Part 11 compliant extended security module addresses the needs of the current regulatory requirements.
PAX-it! uses a SQL database that needs to be installed on the client server. As part of the procurement process we ensure your IT department is aware of their role in the installation and training process. This ensures a seamless installation and validation of the software with our IQ/OQ documentation.
PAX-it is the answer for your microscope software needs and you can be reassured that it has been implemented and has a proven track record in the industry worldwide. Contact our sales team for further information
Who is authorised to access the system
and enter or change data?
Are original data entered directly into an
electronic record at the time of collection or
are the data transcribed from paper records
into an electronic record?
Are there edit checks and data logic
checks for acceptable ranges of
Microscope software in the past has been left as an open platform for manipulation of data. With the introduction of Data Integrity guidelines there is now an increased awareness around the integrity of an image captured from a microscope and the results of the data analysed. The PAX-it! extended security add-on includes additional layers of protection to ensure you meet the high security standards set by the FDA.