Quality Control in Life Sciences

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

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

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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Increase QC lab productivity and compliance

Accelerate batch release and stability testing with automated QC data workflows