EBR for paperless manufacturing in USA | EBR systems paperless manufacturing
eBR systems are more reliable and compliant than traditional paper documents; log-in measures, electronic signatures, and e-traceability are only a few of the key advantages of digital records over paper-based ones. Regulators and inspectors prefer by far these new technologies when they perform regular audit visits to our companies.
The support of a strong IT group in our pharma companies is essential. This group must make proper cyber risk assessments to ensure the security and integrity of the e-systems, protecting them from internal and external attacks. At the end, it is not different from the safety of e-banking systems, as an example of a few.
In the current hard supply chain environment that we have in our pharmaceutical industry in these post-pandemic years, the integration of all our systems is critical to achieve success in all our production sites. Sales forecasting, stocks, lead times of the suppliers, etc. must be fully available, and with online time refresh, to give the right inputs to supply chain professionals so they can make the right and accurate decisions to assure WW Pharma supply chain, essential to ensure also the right treatment to all patients that are needed.
The electronic systems have a lot of right features to decrease errors in manufacturing execution, for example, auto-corrections, auto-dating and timing, a list of choices so you avoid mistyping, etc. All these systems assure data integrity and avoid mistakes. Of course, the more efficiency of the process is assured through them, as we can see in different KPIs we monitor across our production sites.
You can use different continuous improvement systems, like Kaizen, Six Sigma, etc., but all of them can take profit from eBR systems. We are also nowadays performing a big quality culture program in the company that takes some inputs in a direct way from our e-systems, including eBR, of course.
Today, the full harmonization between your different production sites in the same or different countries is critical. Regulators like the FDA expect quality oversight between all your production sites; you only need to see some of the last warning letters on their WEB. In our case, we have production sites in two different countries, and electronic systems like document management systems for deviations, change control, CAPA follow-up, etc., and eBR for online data sharing are pillars of this objective.
A reliable audit trail system that assures log-on follow-up, electronic signature, and date and time monitoring is essential to ensuring the correct performance of all electronic programs in our company. They are also a key factor for inspections and audits success, as inspectors focus on these points most of the data integrity findings.
We think so, but honestly, we do not have so much experience yet in AI or ML to give solid feedback to our colleagues.
Read more: https://www.pharmafocusamerica.com/manufacturing/ebr-paperless-manufacturing
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