Are you looking for a holistic Life Sciences Solution to meet regulatory compliance requirements, increase efficiency and productivity, balance access, control and localization as well as securely collaborate across the enterprise?
OpenText Documentum for Life Sciences is a basic framework for document management applications that optimizes access, management, and exchange of information in life sciences companies, making information silos a thing of the past.
The pre-configured, integrated solutions are based on best practices for this industry branch and are available as specific business modules for standardized business processes for the business areas of quality assurance, clinical and non-clinical research, and regulatory issues.
Optimal planning, collection, and coordination of clinical studies that can be reviewed at any time
You can improve and review your study’s structure by quickly compiling the necessary documents with the Electronic Trial Master File solution. Collect and synchronize documents with sponsors, clinical contract research organizations, and others. The Solution Suite also enables a real-time insight into the process for capturing study documents and guarantees successful audits thanks to a system that can be reviewed at any time.
Quicker creation, review, and approval of documents subject to compliance
This business model ensures that all documents are completed for submission and have undergone a review and approval process based on industrial standards. They improve authors’ productivity and simplify the review process. Furthermore, the solution enables a quick document search to compile your submission documents more quickly.
Ensure a seamless overview of all regulatory activities
The Submission Store View Solution simplifies the search and request of archived submissions and the documents connected to it. Import regulatory submissions in eCTD, NeeS, or paper format and store them with the accompanying communication. This solution provides you with a comprehensive insight into your regulatory activities. You can easily access correspondence on products or submissions.
Simplified creation, coordination, review, and approval of GMP documents
This user-friendly Solution Suite ensures adherence to compliance regulations for good manufacturing practices (GMPs). Review quality and manufacturing documents and automated, company-wide workflows. Manage industry-specific processes and guarantee appropriate change procedures. This business model allows documents to be quickly and easily shared even with global users.
We developed our 360° fme Professional Services based on our 15+ years of experience working with ECM for life sciences and collaborating with global customers as well as medium-sized manufacturers. We will draw on our industry and content migration expertise, proven Prince 2-based project management methodology, and Roll Out Support (module-by-module vs. complete solution) to make your project a success. We are happy to help you, whether you require a local solution or a solution operated from a private, public, or hybrid cloud.
We will help you throughout the entire lifecycle, from process analysis, solution development, installation, and configuration through to adaptation, integration, global operation, and round-the-clock support.
Our migration-center is the bridge between your content in file or legacy systems and OpenText Documentum for Life Sciences. Understanding the target Opentext Documentum for Life Sciences object design based on the principles of the DIA reference model is one of the core expertise areas of fme for migrations. Further, fme’s migration-center software combined with best practice experience qualifies fme as first choice for Life Sciences companies to support complex and critical migration projects.
For specific migration paths with the target of D2 based systems, migration-center supports a so called in-place migration to streamline the process. Object IDs and audit trail entries remain during this conversion.
migration-center Validation Package
The migration-center Validation Package is a new and exclusive approach based on best practices that simplifies the verification process and therefore reduces the time the business is involved in migration projects. This additional package for migration-center projects consists of two basic components: A collection of needed document templates and consulting services to adapt the templates to the individual client validation needs.
Now, with fme and the OpenText Documentum for Life Sciences, you are embracing the future with unprecedented efficiency, agility, document control and compliance that‘s key to getting products to market ahead of the competition. We look forward to your challenge!