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ThermoScientific
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A LIMS Solution for Pharmaceutical Manufacturing

Our LIMS for pharmaceutical manufacturing has been developed to meet the unique needs of pharmaceutical R&D and  QA/QC.
The pharmaceutical industry is unique in many ways. The challenges facing pharmaceutical companies, including large pharma, biotech and generic manufacturers are great and include diverse and geographically remote laboratories, regulatory constraints, complex batch management and testing needs, which demand sophisticated, enterprise-level informatics solutions. In this regard, data collection can be both a burden and the solution, for validation comes through information, but the systems that provide the information must themselves comply with the regulatory requirements they work to satisfy. Thermo Scientific* LIMS 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 (from combinatorial screen, preclinical, clinical bioanalysis, manufacturing R&D and production quality control) with their unique needs and workflows, intense regulatory scrutiny that requires a solution that must satisfy both internal and external auditors, including the flexibility to support widely varying review and approval workflows for static data (product specs, study protocols) and dynamic data (test results, batch disposition), pressure to streamline and become more efficient across businesses with clearly demonstrated cost justifications. Find out how our LIMS for pharmaceutical manufacturing can improve productivity while reducing implementation and validation time.
 
 
 
 
Part Number Description   Quantity
INF-11007-PHARM-MAN A LIMS Solution for Pharmaceutical Manufacturing
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Please Note: Availability may vary by country.  
 
By delivering extensive pharmaceutical functionality in the base system, Thermo Scientific LIMS can help pharmaceutical companies lower the total cost of ownership (TCO) of their LIMS by reducing the time it takes to implement, validate, achieve user acceptance and maintain system upgrades, all while improving productivity and end-user experience. Thermo Scientific LIMS deliver many features designed to ensure compliance with FDA and international regulatory requirements, including those of the ICH guidelines and regulations across the world.

  • 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
 
INF-31000
 
 
 
 
 
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