Documentum for Life Sciences

OpenText Documentum for Quality and Manufacturing

Create and manage critical quality and manufacturing documentation using GMP standards

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Overview

Take control of quality and manufacturing documentation with OpenText

OpenText Documentum™ for Quality and Manufacturing manages and controls the documentation lifecycle for quality and manufacturing documents. Documentum for Quality and Manufacturing ensures compliance with current GMP standards using industry-specific data models, audit trails, reporting and e-signature support.

Why choose OpenText Documentum for Quality and Manufacturing?

  • Ensure compliance

    Comply with GCP and FDA 21 CFR Part 11 with audit trails, access and version control and lifecycle management, and enforce approval processes with automatic assignments.

  • Flexible deployment

    Run anywhere with cloud-native software that offers the choice to deploy on-premises, in a hybrid environment or in the cloud.

  • Print traceability

    Trace and control the printing of key GMP documents and leverage OpenText™ Output Server integration for secure access to printers and print output.

  • Easy upgrades

    Leverage containerized architecture to easily upgrade and access new features, capabilities and updates.

How Documentum for Quality and Manufacturing can benefit business

Discover the advantages of using Documentum for Quality and Manufacturing.

Product overview
  • Increase control and flexibility

    Leverage predefined, yet flexible, business rules to streamline the creation, approval, change control and retrieval of quality and manufacturing documents.

  • Seamlessly share content

    Eliminate content import and export across systems with a single authoritative source to manage clinical, regulatory and quality content and processes.

  • Improve compliance and performance

    Ensure compliance and gain insight on day-to-day global performance with real-time visibility, access control, detailed audit trails, e-approvals and e-signatures.

  • Enable easy remote employee and partner access

    Securely and compliantly access stored content from any device and easily manage information and tasks anywhere, anytime.

Features

  • Fast, efficient authoring

    Enforces authoring standards with controlled templates and automatically populates text from document properties, reducing errors and rework.

  • Document change management

    Simplifies periodic review and change request processes to balance flexibility with control, reducing training requirements and increasing adoption.

  • Automated review and approval processes

    Offers pre-defined lifecycles and workflows that ensure appropriate steps are taken for each document type, and enables multiple users to simultaneously review and approve from any device.

  • Controlled and issued printing

    Ensures FDA print control requirements and EMA data integrity guidance compliance using unique print and reprint numbers and automated recall or reconciliation help.

  • Configurable views and watermarks

    Supports print and export control, as well as preconfigured, dynamic watermarking, with overlays to ensure document security.

  • Language localization

    Offers language packs to support users with interface and system messages in their native languages.

Product overview

Take advantage of OpenText and partner services

Deployment

OpenText offers deployment choice and flexibility for Documentum for Quality and Manufacturing.

Professional Services

OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Partners

OpenText helps customers find the right solution, the right support and the right outcome.

Training

OpenText Learning Services offers comprehensive enablement and learning programs to accelerate knowledge and skills.

Communities

Explore our OpenText communities. Connect with individuals and companies to get insight and support. Get involved in the discussion.

Leaders trust OpenText

See how customers are succeeding with Documentum for Quality and Manufacturing.

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Biopharmaceutical company secures IP, improves efficiency and drives up compliance standards with OpenText Documentum for Life Sciences

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Documentum for Quality & Manufacturing resources

What’s new in OpenText Documentum for Life Sciences Cloud Edition (CE) 20.2

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Learning Management Systems and Life Sciences Quality & Manufacturing solutions

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