LIMS Solution for Pharmaceutical Manufacturing

Developed to meet the unique needs of pharmaceutical R&D and QA/QC, Thermo Scientific™ LIMS Solution for Pharmaceutical Manufacturing provide Pharma laboratories with valuable options to address the key challenges they face when selecting a LIMS, which include the need to support the diversity of laboratories and users, intense regulatory scrutiny that requires a solution that must satisfy both internal and external auditors and the pressure to streamline and become more efficient across businesses with clearly demonstrated cost justifications.

• ICH-compliant templates let users build stability protocols and studies
• Unique batch and product oriented design aligns directly with pharmaceutical manufacturing processes, allowing R&D and production data to be logically organized, summarized and reported
• More flexibility for R&D so that users know if the data does not meet the requirements that clinical or production data would meet
• Environmental monitoring included as standard functionality requiring minimum configuration
• Reduced customization means reduced validation, shortened deployment and easier ongoing support
• 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
• Comprehensive test library included as standard functionality, including test methods for dissolution, drug release, dosage unit uniformity, product assays, and a stability module that simplifies the process for designing, implementing and managing stability studies
• The LIMS interfaces with enterprise systems (Document Management, MES, ERP, etc.) and allows for interactions with other data treatment applications
• Integration tools provide a graphical environment to build bi-directional instrument interfaces and application level interfaces
• Easy user acceptance and simple GUI build on Microsoft .NET technology for flexibility and ease of use
• User-based profiles preserve individual user preferences - administrators can easily modify screens, create new functionality and develop version and privilege controlled reports using standard tools such as Microsoft Visual Studio
• Reduced risk of protocol deviations with tracking inventory and notifications
• Report and filter data faster and more efficientyly without IT intervention
• Designed for ease of standardization for global and multi-site harmonization