Thermo Scientific Darwin LIMS is a purpose-built software solution designed specifically to support the complex testing, workflow and regulatory requirements of pharmaceutical R&D and manufacturing quality control.
Challenge
Regulatory compliance. The complexity of pharmaceutical testing. Batch-centric, non-continuous manufacturing processes. These challenges unique to the pharmaceutical industry have required drug companies to undergo lengthy, costly customisation projects for the generic laboratory information management systems (LIMS) that are critical to the management and security of their data. And for the approximately 15 years it takes to bring a drug from discovery to market, data is the only asset a pharmaceutical company has.
Facing continuous pressure to control costs and increase efficiency, the pharmaceutical industry is looking to technology vendors for real solutions. Purpose-built software that delivers extensive pharmaceutical functionality off-the-shelf can help significantly reduce the time it takes to implement and validate a LIMS, increase user acceptance and simplify future system upgrades.
With purpose-built functionality that is supported by the Thermo Scientific helpdesk, covered in the Darwin user manual and incorporated into the upgrade process, Darwin LIMS is significantly different from generic LIMS that require extensive customisation to meet pharmaceutical requirements. Out-of-the-box functionality can significantly lower the cost of implementation and validation for pharmaceutical customers and minimise project risk. Reduced customisation means reduced validation, shortened deployment and easier ongoing support.
Purpose-built functionality
Darwin was built from the ground up with standard functionality to serve the unique needs of pharmaceutical R&D and manufacturing QC labs. Customer-defined compliance configurations, auditing, electronic signatures and justifications can be tailored to meet every department’s needs. Data can be assigned to the appropriate compliance level to allow researchers greater flexibility during exploratory work, while still enforcing adherence to company SOPs and regulatory guidelines for cGMP quality control data. ICH-compliant templates are included to let users start building stability protocols and studies as quickly as possible.
Darwin features a comprehensive test library that includes complex pharmaceutical testing methods for
- Dissolution
- Drug release
- Dosage unit uniformity
- Product assays
- Stability
- Environmental monitoring
Integrating into the enterprise
Darwin interfaces not only with database systems such as SAP, but allows interactions with other data treatment applications. Integration tools provide a graphical environment to build bidirectional instrument interfaces, database interfaces, and application level interfaces. Darwin comes pre-configured to integrate with Thermo Scientific systems, including the Atlas™ chromatography data system.
User acceptance
Darwin was designed with user acceptance in mind. The graphical user interface is modeled after the popular Microsoft® Office suite of applications, and is immediately familiar to new users. The Darwin interface is also extremely flexible. In addition to user-based profiles which preserve individual user preferences, administrators can modify screens, create new functionality and develop version and privilege controlled reports using industry standard tools such as Microsoft Visual Studio and Crystal Reports.
