Delivers quality and manufacturing solution on its robust ECM-BPM platform
Newgen Software, a leading global provider of Business Process Management (BPM), Enterprise Content Management (ECM), Customer Communication Management (CCM), and Adaptive Case Management (ACM) solutions has announced its foray into the global pharmaceutical industry with a comprehensive quality and manufacturing solution built on its scalable ECM & BPM platforms. The solution is designed to facilitate Good Manufacturing Practices (GMP) compliance by ensuring end-to-end document management.
“Pharmaceutical and life sciences organisations depend on secure, version-controlled document management to meet the strict regulatory requirements of the drugs manufacturing process”, said Diwakar Nigam, Managing Director and Chief Executive Officer, 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,” Nigam added. “Newgen’s quality and manufacturing solution for pharma 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.
Newgen solution includes features that enable content creation (Dictionaries and taxonomies, document templates, auto-naming/linking), content transformation (PDF rendering, overlay, watermark, controlled printing, PDF Annotation), content lifecycle management (Workflow, task notification, change control, version management) and content compliance (features to enable adherence to FDA 21 CFR Part 11 requirements for electronic records including electronic signatures and audit trail, search, reporting dashboards).
Quality and manufacturing pharma solution offers significant benefits including 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.
Leveraging the power of OmniDocs ECM and configurability of OmniFlow BPM, Newgen will look 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 pharma space.