Newgen Software announced its foray into the global pharmaceutical industry with a comprehensive Quality and Manufacturing solution built on its scalable ECM and BPM platforms. The solution is designed to facilitate Good Manufacturing Practices (GMP) compliance by ensuring end-to-end document management.
“Pharmaceutical and life sciences organizations depend on secure, version-controlled document management to meet the strict regulatory requirements of the drugs manufacturing process,” said Mr. Diwakar Nigam, MD & CEO – Newgen Software. “Consequently, the documentation practices within a company can directly impact the level of success in manufacturing quality products that are safe to use,” Mr. Nigam added. “Newgen’s Quality and Manufacturing Solution for pharmaceuticals ensures organization-wide consistency and compliance by enabling enterprises to create, manage, and securely store documents, with built in password policies to prevent any unauthorized access.”
The solution caters to the wide range of requirements of pharma companies including compliance to the GMP mandates, essential for production records. The GMP regulations come with extensive documentation needs, non-compliance to which can lead to production interruptions, consent decree fines, and regulatory warnings besides denial of drug entry into market, which can cause losses amounting to a million dollars per day.
