Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision.
Banerjee recommends that every business start the process with an internal needs assessment. With regards to his own due diligence process, he shared, “We started out by asking ourselves, ‘ what is it that people actually need to do internally and what are they doing right now?’ So we walked through the manual process that was taking place and hypothesized as to how an eQMS could help us to automate different parts of the process. And we came up with a detailed requirements and a specification for what the electronic quality management system (eQMS) should do.”
While every life sciences company will inevitably have some unique needs and business processes, Banerjee suggests that there are a number of requirements that are universal and should be taken into consideration in the vetting process. First, he recommends that businesses prioritize eQMS solutions that tie together document management and training in a seamless manner in order to have a 100% paperless process. And relatedly, the system should be 100% compliant with electronic records and electronic signature regulations, such as 21 CFR part 11 and E annex 11.
In addition, Banerjee recommends selecting an eQMS that allows your team to execute corrective and preventive actions (CAPAs) in an automated manner and enables you to tie the resolution of those CAPAs to document revisions and the completion of related training courses. And furthermore, the system should allow your team to manage audits on a centralized platform and tie audit responses to CAPAs, procedural updates, and training.
To hear more tips for selecting an eQMS system, including recommendations for securing internal stakeholder support, watch this video featuring Sourav Banerjee>>