qSync™ is an AI and machine learning software that digitizes end-to-end batch records for Continued Process Verification (CPV) without changing your existing qualified process without making expensive, risky system changes.
Reduces compliance risk in executing CPV
Lowers staff scientist workload and cost
Improves CPV analysis and metrics
HOW DOES THE SOLUTION WORK:
Install and qualify qSync software securely within your firewall
qSync digitizes paper batch records - including handwriting
qSync links batch records to MES, LIMS master & transactional data sources
qSync provides a robust, GxP compliant verification and data adjudication workflow
WHAT DO THE AGENCY REGULATIONS STATE?
The FDA specifically requires an ongoing program for collection and analysis of process data: Continued Process Validation under §501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)) and further specified in (§ 211.180(e)).
Continued Process Verification is a mandated compliance framework to assure that manufacturing processes for drug substances are controlled and measured according to documented Critical Process Parameters during late-stage clinical and commercial production.
The FDA recommends that appropriately trained statisticians and/or professionals certified in statistical process controls develop and measure the process controls for intra-batch and inter-batch variations as part of a comprehensive CPV program to monitor, assure, and improve product quality.