Life Sciences Project Sampling
Technology Services Group offers many services and solutions to assist the Life Sciences Community.
Clients typically spend a lot of money and effort developing a robust interface for their authors and approvers, but often this interface can be "too much" for users just looking to view and print approved documents. These light-weight users typically make up a majority of the user community. TSG has implemented a simple search, view and print interface for many life sciences clients to significantly ease the effort and time to retrieve documents and reduce training and support costs. The approach also minimizes the load (both processing and licensing) on the core controlled document management system while providing business continuity.
TSG has extensive experience implementing controlled documentation and electronic change request systems for multiple clients using various technology solutions including extending Documentum Webtop, Documentum Content Manager (DCM), and integrating the Active Wizard, which is our open source forms and workflow solution (www.activewizard.com). TSG has a deep understanding of the technical and business process issues surrounding these applications. We can share best practices, lessons learned, and assist our clients in choosing the technical solution that best meets their business needs.
Regulatory agencies (FDA, EMEA, etc.) are requiring more and more content to be submitted in an electronic format. Common misconceptions are that e-Submissions systems cost millions of dollars, and publishing the data into the eCTD format is the most complex part. both of these assumptions are wrong! e-Submissions systems can be implemented for far less than $1M and the most complex part of the application is defining the business process and resulting solution that is responsible for managing applicable documents and making them "submission ready". For more information and best practices on this topic, click here to view our recorded event.
Many of our life sciences clients have recently looked to their content management systems to manage the editing, review, approval, and distribution of their marketing / promotional materials. Systems have been implemented using various technology solutions including extending Webtop, integrating DAMTop, and utilizing the Active Wizard our open source forms and workflow solution (www.activewizard.com). We have a deep understanding of the technical and business process issues surrounding this implementation. We can share best practices, lessons learned, and assist our clients in choosing the technical solution that best meets their business needs.
We have implemented a solution for our clients to share controlled documents (i.e. submission, quality), with external parties such as clinical research organizations and third party manufacturers. Our solution allows the documents to remain secure (eliminates e-mails and faxing), and exposes corporate standards, templates, and processes to external sources. It also provides electronic approval capabilities for external sources, and reduces turn around time by providing timely feedback and input from external sources.
Since our life sciences clients have been using Documentum for years, their user base is quite extensive and as a result it is becoming more and more important for our clients to simplify the user interface. Through our client engagements, TSG has developed an open source offering, HPI (High Performance Interface), which simplifies the user experience while enabling users to efficiently perform the most common document management tasks such as review, approve, and edit. Additional features such as a dual pane viewer and the ability to quickly view related content has proven invaluable for our clients.
TSG has been a thought leader in implementing Documentum applications to manage complex forms (e.g. Change Request, Product Change Notification). We have utilized our open source configurable form and workflow tool to reduce errors and cycle time for form completion and approval. By providing a dynamic form (ActiveForm) with an intuitive "Wizard" approach, requestors are able to quickly and accurately complete the form. Business Rules are built around the form to provide dynamic workflow (ActiveWorkflow) capable of addressing a dynamic approval process as well as signature reduction requirements.
Our life sciences clients regularly load Documentum with new content due to reorganizations, mergers, and upgrades. As a result of our numerous migration experiences, TSG has developed both a methodology and an open source framework, OpenMigrate, to jump start their migration efforts. OpenMigrate provides a highly configurable, modular, and extensible framework to address both one time and ongoing migrations with a flexible and high-performance architecture. OpenMigrate is our answer to the shortcomings of typical Documentum migration utilities.
Our life sciences clients typically deploy solutions that include watermark or overlay components to dynamically apply property information such as approval date, document number, and status to the document. Many of our clients initially installed a solution that left a heavy footprint and required separate servers. From the experience gained deploying various watermark solutions TSG developed a lightweight open source solution, OpenOverlay, which can be used to apply watermarks, overlay dynamic headers and footers, append electronic signature pages, insert controlled print and batch record information, as well as perform other PDF manipulation.
Electronic review and approval of documents is an important component of ECM solutions for most of our life sciences implementations. OpenAnnotate, TSG's newest open source offering, greatly simplifies the solution by providing annotation capability without requiring any additional client machine dependencies or licensing costs. OpenAnnotate is a browser-based tool that allows users to create share and view annotations on a document within your ECM environment (Documentum, Alfresco, etc.)
Common ECM pain points for our life sciences clients are the frequency of upgrades and the efforts involved to be on supported software versions. Many of our clients have been implementing solutions with service-oriented architectures (SOA) to limit the impact of upgrades on their customized functions. SOA can also be used to reduce the code base, which allows business logic to be accessible by multiple applications. TSG has developed an open source web services layer, packaged as OpenContent, that abstracts the Documentum logic from the business logic so that it can be leveraged from any number of web or command-based applications.
Converting paper documents into an electronic format and managing those documents are still important components of document management for our life sciences clients. In addition to many implementations, our founder's roots are in this area; therefore we frequently draw on those years of experience to serve our clients. We are able to provide technical guidance in areas such as selection of scanners and software, long-term storage, and Documentum integration. We also leverage our industry experience to help our clients streamline their processes and discuss outsourcing benefits and drawbacks.