Increase QC lab productivity and compliance

Accelerate batch release and stability testing with automated QC data workflows

Remove your quality control bottleneck

Quality Control (QC) is typically seen as a bottleneck to releasing product inventory to the customers and patients. TetraScience can help you to increase QC productivity and efficiency:

  • Eliminate manual transcription, collection, and aggregation of analytical data that is time-consuming and leads to errors and compliance issues
  • Minimize review time with full traceability and by eliminating second scientist review due to automated flow of data from instrument to ELN/LIMS
  • Automatically harmonize and enrich data for easier search and trending of results across different techniques and vendors
  • Access and reuse data in any laboratory informatics applications  of your choice - today and in the future
  • Track all tests performed on samples and batches for the duration of the study
  • Trend critical quality attributes (CQAs) and specifications to identify events that are Out-of-Specification (OOS), Out-of-Trend (OOT) and  outside the expected variability of the analytical procedure (OOE) before they happen

Support your QC-related workflows and requirements

Batch release / QC

  • Make all data searchable and accessible by project, theme, or lab by creating “collections” to group experiments
  • Access complete batch data across instruments or vendor types
  • Compare data from different instruments and vendors for insights across manufacturing sites

Raw materials testing

  • Compile and compare all results of purity, identity and quality testing of your raw materials
  • Track and trace all raw material components including pharmaceutical substances, intermediates and excipients to finished products
  • Get insights into product quality across sites and easily identify and investigate OOS

Stability testing

  • Support ICH and Annex 5 relevant real-time stability testing, intermediate studies, and accelerated stability testing for shelf-life determination
  • Access and aggregate data from chemical, physical tests, microbiological limits, and preservative effectiveness testing
  • Track and trend the results to  identify potential shelf life limitations before the endpoint of testing
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Data traceability and integrity

  • Ensure accuracy, completeness, quality, and traceability of all data through  comprehensive audit trails and support adherence to ALCOA+ principles
  • Access all information about when, where, and how a sample was run, including timestamps and instrumental metadata
  • Rely on data security through secure cloud-based storage

Manual steps are error-prone and slow down batch release and stability testing

Optimized, automated processes accelerate batch release and stability testing

batch-release-workflow

Centralized, harmonized data helps companies automate workflows and reduce manual labor, achieve consumables cost savings, and streamline reporting between functions

Unlocking insight: chromatography data

Global pharmaceutical companies are partnering with TetraScience to unify, harmonize, and analyze the large volumes of chromatography data. Learn more about how a Top 15 Global Biopharma use Tetra Scientific Data Cloud to track system suitability, column lifetime, and API shelf life from a single software system.

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Trusted by 15 of the top 25 Pharmas 

Learn how you can accelerate and improve scientific outcomes with the Tetra Scientific Data Cloud.

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