Pharma eQMS Solution

Quality doesn’t just make good business sense - it’s also a matter of viability and compliance in regulatory environments. Using a purpose-built eQMS for pharma can significantly reduce compliance burdens because it can automate the management of essential quality tasks as well as essential documentation, which forms the basis of any compliant system.

The regulations that relate to any digital quality management solution are outlined in 21 CFR Part 11. Current Good Manufacturing Practices (CGMPs) for all pharmaceutical manufacturers are outlined in 21 CFR Part 210/211. A purpose-built eQMS for pharma is a digital system designed to help pharmaceutical companies more easily comply with CGMP. Essential functionality must include document, training, and quality event management.

Pharma eQMS software reduces manual transcription errors and allows you to store essential documents, like standard operating procedures (SOPs), in once place. This means an eQMS is audit-ready all the time. A robust eQMS can automate document workflows (i.e., revision, review, and approval cycles) with e-signature technology and enforce versioning control. It can also support multimedia files, such as photographs and videos. 

The ultimate objective of implementing an eQMS for pharma should be to streamline compliance, which substantiates product safety and efficacy. What’s more exciting about transitioning from manual systems to digital ones is that easily configurable eQMS software is proven to inspire quality personnel to improve and revise processes, which in turn makes it easier to develop new products.