The Pharmaceutical Sector as a market sector is never short of guidelines and it is often a difficult job for the Quality manager to interpret all of the information from the various regulatory bodies.

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

Typical inspector questions include:

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 Authorisation to system

Who is authorised to access the system
and enter or change data?

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Electronic Records

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?

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Edit Checks

Are there edit checks and data logic
checks for acceptable ranges of
values?

PAX-it! Microscope imaging software is unique and the easiest way to keep encrypted records on all image processes.

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.

PAXcam

Features of PAX-it extended software:

  • Electronic records and signatures to keep your assets secure, complete with authentication tools and alerts

  • Detailed audit trails that track all digital manipulations, and provide a searchable report of all changes

  • All image files are retained by the system. If the user saves a newer version of an image, it is assigned as a copy of this image and does not overwrite the original data.

  • Administrative tools including unique logins and user permissions

Companies who rely on PAX-it!:

Merck, PAX-it - Trusted by Companies Around the World
ExonMobil, PAX-it - Trusted by Companies Around the World
Pfizer, PAX-it - Trusted by Companies Around the World
Medtronic, PAX-it - Trusted by Companies Around the World
Abbott, PAX-it - Trusted by Companies Around the World
NASA, PAX-it - Trusted by Companies Around the World
Firestone, PAX-it - Trusted by Companies Around the World
Bristol-Myers Squibb, PAX-it - Trusted by Companies Around the World
Centers for Disease Control and Prevention
Lucent Technologies, PAX-it - Trusted by Companies Around the World
GE Imagination at Work
Texaco, PAX-it - Trusted by Companies Around the World
Hewlett Packard, PAX-it - Trusted by Companies Around the World
Procter and Gamble, PAX-it - Trusted by Companies Around the World
Dupont, PAX-it - Trusted by Companies Around the World

As the principal distributor for PAX-it! in the UK and Irish market, Mason Technology can advise and install the compliant software in your business. Get in touch with one of our team for further information on how PAX-it! can benefit your organisation.


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