The most crucial component of Pharma Manufacturing Operations is QMS
Usually, this is performed manually by a key individual in the company, and the absence or neglect of this person influences the audit quality. Automation, thus, being a superior alternative, enhances efficiency and offers a better outcome on data integrity.
Our Enterprise Quality Management Solution is a COTS system that facilitates compliance and automates the whole process. There are quality criteria for the program, which provides for maximum control and transparency. The software also addresses quality concerns at their source, allowing pharmaceutical businesses to adapt and comply strictly with the rigorous requirements imposed by worldwide regulatory authorities. For example, the US Food and Drug Administration, the MHRA, and the WHO
CAPA Tracking, Change Control, Market Complaints, Deviation management, vendor qualification, audit management, OOS/OOT, document management, and training management alongside powerful automation with intelligent tracking are some of the modules found in the pre-configured Integrated Quality Management System (QMS)
Enterprise Quality Management Software (EQMS) system minimizes the chances of quality process failures, lowers the total cost, and improves organizational compliance.
Despite these benefits, are Life sciences companies ready to make an immediate shift from manual to automated processes?
AmpleLogic has created a low code-based eQMS software based on input from Pharma businesses on their automation problems as well as their work cultures. This program provides users with a comprehensive perspective of the Quality management process. With highly flexible processes, organizations may now easily control and comply with the most stringent quality requirements (such as 21 CFR part 11, EU ANNEX 11, and cGMP).
Due to AmpleLogic’s LOW CODE Platform, organizations may experience a seamless connection between modules, reduced rework, address data reliability, and Security with 21 CFR Part 11 and other GMP compliance standards.