Statistics for
GxP Compliance
Our robust, regulator-approved quality management system ensures that we can help prepare your project to GMP standards at every stage, whether that’s early development or approaching regulatory approval.
Quantics is proud to maintain an ISO9001 accredited quality management system, meaning we are able to offer GMP-compliant statistics for routine and bespoke statistical analyses.
Providing GMP statistics all year round
Same day draft reporting for routine GMP statistical work
Ready for use QA report within 2 days for all GMP routine work
Guaranteed 100% QC check of every result
Fast, reliable service customised to your needs
Full process control support / trending if required
Continuous real-time Validation (CrtV) for GMP
Quantics employs an innovative approach to ensure each and every calculation meets the highest quality standards: Continuous real-time Validation (CrtV).
CrtV employs a programming technique known as Diverse Self-Checking Pairs (DSCP). Each analysis is programmed in two different programming languages by two different programmers. Each result is cross-checked between the two branches, and only if the results match are they considered valid.
From a QA perspective, this means the process is robust to bugs or errors in software: an error in one branch would cause a mismatch, and the results rejected before they can cause harm. For buggy code to produce incorrectly matching results, a different error must occur in each branch while still producing the same result. Needless to say, this is extremely unlikely. And, from a QC perspective, CrtV means every result – not just a subset – is checked for validity.
CrtV provides an efficient and robust route to the highest quality standards, meaning it is the optimal solution for GMP-compliant analyses.
Get in Touch!
Want to find out more about how Quantics can support your GMP statistics? Book a discovery call with our Customer Experience Manager, Andy Rust, using the form below!
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