Newgen Pharma Solution

Enable organization-wide consistency in manufacturing quality standards

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  • Enable Goods Manufacturing Practices

    Meet the complex requirements of ‘The Goods Manufacturing Practices’ and safeguard your enterprise from compliance lapses.

  • Enhance Overall Productivity

    Smart tools for document management and approval workflows, improve enterprise wide information management and collaboration.

  • Prevent Legal Hassles

    Prevent running into legal issues which can otherwise lead to heavy fines, impacting your overall profitability.

The Global Pharmaceuticals Industry is witnessing a paradigm shift, simulated by a combination of market consolidation and advancements along the production value chain. These have prompted innovations and unprecedented operational efficiency for manufacturers but also led to greater emphasis on regulations such as The Goods Manufacturing Practices (GMP). The GMP regulation requires maintaining of extensive production documentation in compliance with requisite federal standards for product quality and safety.

The manual management of these documents leads to several constraints and challenges such as:

  • Maintenance of FDA 21 CFR part 11 compliances
  • Producing accurate documentation for Regulatory GMP Audits
  • Ensuring compliant processes for change control and CAPA
  • Efficient storing and handling of production records

Brochure: Newgen’s BPM & ECM Solutions for Pharmaceuticals Industry

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The Newgen Solution for Pharmaceutical Enterprises helps businesses overcome these challenges with its unique features and functionalities

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

The Solution provides out of the box compliance with 21 CFR part 11 including capabilities such as:

  • Capturing electronic signatures
  • Document-level audit trail and reporting
  • Authorization based controlled access to documents
  • Workflow based sequencing of steps and events for document lifecycle management

Comprehensive Document Management

Comprehensive Document Management

Documentation is a critical aspect of GMP and the Newgen Pharma Solution provides comprehensive document management capabilities such as:

  • Creating requests for new documents as well as revise documents as part of change control while managing their versions (check-in and check-out)
  • Predefined template driven authoring, based on the specific selected property values
  • Document centric workflow for enabling creation review, approval, and disposition based on predefined lifecycle
  • Linking of multiple documents and records as references to main document under creation or revision
  • Application of watermarks and overlays a document’s header, footer, or across each page to see the current status or effective date of the document

Advanced Workflow Capabilities

Advanced Workflow Capabilities

The solution offers a robust configurable workflow helping enterprises

  • Capture, manage and track all approvals, comments and rejections
  • Manual or automatic triggering of processes based on metadata conditions or business rules
  • Auto notifications to reviewers and approvers for statuses on task and actions based on business rules

Dynamic Security and Control

Dynamic Security and Control

With the Newgen Pharma Solution, businesses have complete control over issuing document copies by managing their end to end creation and distribution. The solution offers security features such as

  • Automatic access control applied on a document’s lifecycle state
  • Defined document specific parameters and user roles

Master Data Management

Master Data Management

The solution easily manages master data and the hierarchy of relationships between data values.

Robust Audit Functionality

Robust Audit Functionality

The Solution has been developed bearing in mind the stringent regulatory landscape of the Pharmaceutical industry and offers robust audit capabilities including

  • Audit reports on all production and SOP documents pertaining to user actions such as view content, sign-offs and overdue tasks can be accessed
  • Visibility to quality managers to ensure that reviews are started and completed in a timely manner through automatically triggered review reminders for documents based on pre-defined rules

Reports and Dashboards

Reports and Dashboards

The Newgen Solution for Pharmaceutical enterprises helps organizations maintain tighter control over processes with the help of configurable reports and dashboards

  • Real-time and role-based reports to keep stakeholders updated on all tasks periodic reviews, expiration of documents and more
  • Configurable reports and dashboards which can be created and shared by individual users to indicate various performance indicators
  • Dashboards to indicate the adherence to GMP and other regulations

Records Management

Records Management

The solution comes with extensive capabilities for managing archival, retention and disposition policies for both paper-based and electronic documents.

  • Provides administrative reports for easy and efficient management of records as well as administration
  • Powerful search feature allows users to quickly find and retrieve documents that they need through full text and attribute/metadata searches

Newgen Customers in Pharmaceuticals

lupinstridesLogoglaxosmithklineBDsigmaalorichJohnson & JohnsonastraLogoranbaxyLogosunmenarini

Benefits of choosing The Newgen Solutions for Pharmaceuticals

  • Out of Box compliance with FDA 21 CFR part 11 regulations
  • Quick access to document audit reports for GMP compliance audits
  • Controlled access to quality and manufacturing related documents through a single unified repository
  • Easy dissemination of SOPs for employee trainings, enabling TBR audits
  • Shortened document review/approval timelines
  • Increased productivity through re-use of existing document templates

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Newgen solutions for Pharmaceutical industry offers following benefits:

  • out of the box compliance with 21 CFR part 11 including capabilities
  • comprehensive document management capabilities
  • robust configurable enterprise class workflow
  • Automatic access control applied on a document’s lifecycle state
  • master data management and the hierarchy of relationships between data values
  • Audit reports on all production and SOP documents
  • configurable reports and dashboards
  • archival, retention and disposition policies for both paper-based and electronic documents