There is no shortage of regulatory advice and Guidance on Data Integrity. The sources the Quality manager needs to be reviewing come from 5 key sources.
FDA guidelines can be found in their Inspection or Pharmaceutical QC labs, 1993. Compliance program guide 7346-832,2010. Level 2 guidance on FDA website,2010.Data Integrity and compliance with CGMP,2016
MHRA have their guidance for Industry on GMP Data Integrity,2015 with their draft guidance for Industry on GXP Data Integrity,2016. The final version is due in August 2017.
WHO Good data and record management practices,2016
EMA Data Integrity Q&A,2016
PIC/S Good practices for Data Integrity management, 2016.
The GAMP Records and Data Integrity Guide was published in April 2017
The common trend in all the guidelines is a move toward fully electronic solutions. These systems will have configured methods which guides the user through what was a manual SOP. This removes the human error from the test.
To achieve this trend all legacy manual and Hybrid systems in the laboratory will need to be replaced.
Legacy microscope systems
We 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 one 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 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.
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of Biotechnology, Pharmaceutical, and Medical Device industry’s responsibility to ensure the safety, efficacy, and quality of each product. These data integrity-related CGMP violations have led to numerous regulatory actions.
Agencies expect that pharmaceutical companies retain complete and accurate records along with all raw data and can to make that available to inspectors. The integrity of data generated by regulated pharmaceutical companies and laboratories matters more, because properly recorded information is the basis for manufacturers to assure product identity, strength, purity, safety and non-compliances found in integrity of data. Invalid or non-reliable data is a sign of poor control on operation and equipment.
Electronic signature and record-keeping requirements are laid out in 21 CFR Part 11 and apply to certain records subject to requirements set forth in agency regulations. PAX-it! extended security is one of few microscopy software’s available that can comply with all of the standards that are required for 21 CFR Part 11.
There has been a reluctance for Quality departments to challenge USP methods like USP776 as they are based on manual inspection methods. PAX-it! works to the USP methods while interpreting them to work within a digital solution. PAX-it! will make your microscope and software compliant while reducing operator workload simultaneously. In the long run becoming compliant will free up your human resources and save your organisation money.
It may be possible to upgrade your current microscope to become compliant so please contact us directly so we can assess your needs.