There are several challenges to maintaining the ever increasing amount of data and documents that face clinical and non clinical laboratories. First, how does the laboratory organize, store and retrieve these data and documents in a way that is FDA 21 CFR Part 11 and GLP, GCP compliant and efficient especially when 80% of that data is unstructured data (i.e., free form notes, procedures, letters, reports, etc.)? Second, how does the laboratory maintain control on the data and documents to ensure their integrity? Third, How does a laboratory analyze long term trends in data to answer questions like "Can we pull up methods; data, etc to make sure methods etc. are the same? Or can we make a correlation to clinical data from previous clinical trials?"
Most systems are very limited and inflexible in how they deal with scientific data. Labcore enables laboratories to implement robust and compliant Scientific Data Management architecture. This information management platform is an automated electronic repository that stores and manages all types of scientific data to a centralized database, offering excellent integration with the majority of the applications that researchers use.
To see how Cary Institute of Ecosystem Studies implemented Labcore to address its scientific data management needs watch this educational webinar or request the full Cary Institute case study at Case Studies
Labcore SDMS will not only captures and stores the critical scientific data generated by most instruments or applications in an automated manner that requires minimal operator intervention, it will allow your laboratory or organization to perform several other critical functions needed for a truly effective Scientific Data Management architecture:
- Search and retrieval of the documents by specified criteria or metadata as an individual file or as a correlated report.
- Viewing and download of the documents in their native file formats.
- Allows for export of the data to long term storage media such as CD or DVD.
The Labcore SDMS exchanges data with electronic laboratory notebooks (ELNs), LIMS, EDMS and other common enterprise technology systems. Labcore SDMS seamlessly integrates with your existing IT infrastructure, scales to the enterprise, provides data security, offers central or distributed administration and can be quickly deployed.
The advanced features of the Labcore such as digital signatures, version control and document audit trail are available to ensure that the data or any correlated documents are kept in a 21 CFR Part 11 compliant system that provides the foundation for scientific data preservation, protection of intellectual property and a collaborative workflow for data and documents throughout your organization. Its web based architecture also means that it is readily scalable and accessible as your organization adds customers and new employees.