Newgen Software will foray into the global pharmaceutical industry with a comprehensive Quality and Manufacturing Solution (QMS) and it would facilitate Good Manufacturing Practices (GMP) compliance by ensuring end-to-end document management.
â€œPharmaceutical and life sciences organisations depend on secure, version-controlled document management to meet the strict regulatory requirements of the drugs manufacturing processâ€, said Diwakar Nigam, MD & CEO â€“ Newgen Software.
â€œDocumentation practices within a company can directly impact the level of success in manufacturing quality products that are safe to useâ€, he said.
Newgen’s quality and manufacturing solution for pharmaceuticals ensures organisation-wide consistency and compliance by enabling enterprises to create, manage, and securely store documents, with built in password policies to prevent any unauthorised 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.
QMS in pharma includes quick access to documents and document audit reports for GMP Compliance audits, controlled access to all pharmaceutical quality and manufacturing documents from a single repository, easy distribution of SOPs for employee training and TBR audits, shortened document review cycles and increased productivity through re-use of existing document templates.
Newgen is about to add new offerings like clinical trial master file and eSubmissions in near future to further expand the scope of its solutions in life sciences and pharmaceuticals space.