OpenText Documentum™ for Quality and Manufacturing manages and controls the documentation lifecycle for quality and manufacturing documents. As part of OpenText™ Documentum™ for Life Sciences, it ensures compliance with current GMP standards using industry-specific data models, audit trails, reporting and e-signature support.
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.
Run anywhere with cloud-native software that offers the choice to deploy on-premises, in a hybrid environment or in the cloud.
Trace and control the printing of key GMP documents and leverage OpenText™ Output Server integration for secure access to printers and print output.
Leverage containerized architecture to easily upgrade and access new features, capabilities and updates.
Discover the advantages of using Documentum for Quality and Manufacturing.Product overview
Leverage predefined, yet flexible, business rules to streamline the creation, approval, change control and retrieval of quality and manufacturing documents.
Eliminate content import and export across systems with a single authoritative source to manage clinical, regulatory and quality content and processes.
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.
Securely and compliantly access stored content from any device and easily manage information and tasks anywhere, anytime.
Simplifies periodic review and change request processes to balance flexibility with control, reducing training requirements and increasing adoption.
Ensures FDA print control requirements and EMA data integrity guidance compliance using unique print and reprint numbers and automated recall or reconciliation help.
Offers language packs to support users with interface and system messages in their native languages.
OpenText offers deployment choice and flexibility for Documentum for Quality and Manufacturing.
OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.
OpenText helps customers find the right solution, the right support and the right outcome.
OpenText Learning Services offers comprehensive enablement and learning programs to accelerate knowledge and skills.
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See how customers are succeeding with Documentum for Quality and Manufacturing.See more success stories