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.

KEY BENEFITS

  • 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

qSync’s handwriting recognition feature can read, recognize and convert handwritten batch records to greatly streamline the FDA regulated Continued Batch Verification process.

qSync’s handwriting recognition feature can read, recognize and convert handwritten batch records to greatly streamline the FDA regulated Continued Batch Verification process.

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.

Mareana combines handwriting recognition, AI text analytics, a flexible, repeatable query engine, and a deep understanding of CPV and associated processes and technology to digitize your process and allow your team to focus on value-added analytics, not data wrangling.