In the highly regulated world of Life Sciences, large volumes of content, both data and documents, are created and exchanged between organizations and health authorities worldwide. The content can be classified or categorized into clinical trial documentation, Regulatory affairs documentation, Regulatory labeling, Regulatory dossiers for publishing and submissions, etc. The biggest challenge for life sciences organizations is to effectively manage the content and documentation across the product and regulatory life cycle with the required collaboration, workflows, security, version control, search and archival. Hence, they opt for proven electronic content management (ECM) and electronic document management systems.
To ensure that such organizations effectively meet their content/document management requirements, Freyr, as a Silver partner of OpenText™, provides robust and cost-effective ECM solution implementation services for:
- OpenText Content Suite
- OpenText Documentum
- OpenText Documentum for Life Sciences
- OpenText Extended ECM
- Other OpenText ECM software and solutions
In addition, Freyr leverages its life sciences Regulatory domain expertise to ensure Regulatory compliance to standards and regulations.
Freyr’s proven expertise for implementing OpenText Documentum include:
- Systems Strategy, Architecture and Consulting
- Deployment Models and Licensing
- Implementation of ECM software and solutions, both on-premise and cloud-hosted
- Quality Assurance (QA) & Computer System Validation (CSV)
- Project Management
- Change Management
- Audit & Compliance
- Electronic Document Management strategies: Retention, Governance, Migration, Disaster Recovery etc.
- ECM Lifecycle Support
- OpenText Documentum Support & Maintenance
- Skilled and experienced Regulatory professionals
- Regulatory Information Management (RIM) Center of Excellence
- Certified OpenText Technology professionals
- End-to-end services for ECM products and validated systems
- Focus on User Experience
Integrating Submissions Publishing and Electronic Document Management Systems (EDMS)
Learn more about Freyr SUBMIT PRO, Freyr’s in-house submissions publishing software, which integrates seamlessly with OpenText Documentum D2 and ensures a single source of truth for global eCTD submissions and submission documents.