Clients: Life Sciences

Document Management in Life Sciences and Pharma

Strator has a long list of clients and projects across various different industries. We are experts in working with documents, content, data and information - at times of  confidential matter. Therefore we do not publish our end-clients details, however the character and highlights of some of our projects are described.

Life Sciences, Denmark: Regulatory Document Management System Upgrade and Rendering
The regulatory document management system based on Documentum and FirstDoc upgraded and an FDA compliant rendering engine configuration moved from Documentum ADTS to Adlib PDF Enterprise. Trusted advisor on the implementation involving architectural and code review and general technical quality assurance and advice and development of technical GxP documentation. Migration of the FDA compliant ADTS configuration to Adlib PDF Enterprise.

Life Sciences, Denmark: Architectural License Review
The extensive Documentum-based architecture audited from a license perspective, and advice on the – from a license perspective – optimal architecture given.

Life Sciences, Denmark: FDA Compliant Rendering
Review of current rendering architecture and configuration of FDA compliant rendering in Documentum ADTS.

Life Sciences, Denmark: Regulatory User Management
Automatic maintenance of user information in Documentum environments based on SAP HR data.

Life Sciences, Denmark: Search Engine Configuration
Upgrade to new search technology and configuration of search engine, Documentum xplore.

Life Sciences, Denmark: System Administrator training
Custom workshops on Documentum operations and system administration deep-diving in the search engine configuration (xplore), rendering configuration (ADTS) and proper maintenance for good system performance.

Life Sciences, Denmark: FDA Compliant Rendering
Upgrade of current rendering architecture of FDA compliant rendering in Documentum ADTS.

Life Sciences, Denmark: Regulatory Document Hub
In an architecture where the Regulatory Document Management System receives documents from many different sources, the integrations became a tough maintenance and validation burden. The idea of the document hub was to wrap the core document management services and expose these in a very well defined interface to the document sources, thus eliminating the need for custom integrations and revalidation of document system when external systems changed.

Life Sciences, Denmark: Submission Archive
End-to-end implementation of an archive for electronic regulatory submissions including requirements development, technical implementation, GxP documentation, user training, super user training.

Life Sciences, Denmark: Regulatory Document Management and Rendering
The regulatory document management system based on Documentum and FirstDoc upgraded and an FDA compliant rendering engine configured. Trusted advisor on the implementation involving architectural and code review and general technical quality assurance and advice and development of technical GxP documentation. Development of an FDA compliant configuration of the rendering done by Documentum ADTS.

Biotech, Denmark: Regulatory Content Management System
Documentum based solution configured for research documentation and quality assurance documentation. For 5 years now we have regularly attended to the installation and ensured proper performance, stability and security and as a result, the customer has experienced no unplanned system downtime.

Biotech, Italy: Regulatory Document Control
Controlled scanning, classification, QA and secure transfer of historic eCTD documents from a local office to headquarter in Italy. Since the large project, regularly smaller amounts of electronic documents are delivered for QA, classification and secure transfer to headquarter.

Biotech, Denmark: Regulatory Rendering
Regulatory Document Management solution based on Qumas evaluated with regards to the rendering architecture and quality.

Medico, Denmark: Requirements for Regulatory Document System
Business requirement gathering and requirement specification for a replacement of an existing regulatory document management system including considerations rg. migration of existing content and document history.

Life Sciences: Denmark: Regulatory Labelling Solution
Solution for regulatory labelling based on Documentum and Adobe. Trusted advisor on the implementation involving architectural and code review and general technical quality assurance and advice and development of technical GxP documentation.

Life Sciences, Denmark: Regulatory Product Database
Solution for registration of the products marketed in each country and the status of the submissions approval, names etc. Trusted advisor on the implementation involving architectural and code review and general technical quality assurance and advice and development of technical GxP documentation.

Life Sciences, Denmark: Clinical Trial Business System Analysis
Business requirement gathering, search and selection of system for clinical trial documents.

Life Sciences Consulting, Denmark: Conversion
Establish and maintain a regulatory conversion solution