グローバルインサイト： AmpleLogicの評価

International Journal of Pharmaceutical Sciences (Sharma, Chankhore & Mhaske)

Published in IJPS (2024), this review paper examines Quality Assurance and Quality Management System principles in pharmaceutical manufacturing — covering GMP, ICH guidelines, Quality by Design (QbD), Total Quality Management (TQM), and electronic QMS platforms. It references AmpleLogic among key software solutions for pharmaceutical quality management, regulatory compliance, and continuous improvement in life sciences operations.

International Journal of Pharmaceutical Sciences (Manocha, Chouksey et al.)

Published in IJPS (2025), this peer-reviewed paper provides a comprehensive framework for AI-powered Annual Product Quality Review (APQR) in pharmaceutical manufacturing, covering FDA 21 CFR 211.180(e), EU GMP Annex 15, and ICH Q7/Q9/Q10 compliance. It references AmpleLogic's APQR software for predictive analytics, anomaly detection, and automated trend analysis across batch manufacturing, stability, OOS/OOT, CAPA, and complaint data.

International Journal of Computing and Engineering (Potharalanka, 2025)

Published in the International Journal of Computing and Engineering (2025), this peer-reviewed paper examines how regulatory-aware low-code platforms embed compliance directly into the development lifecycle through visual rule builders, policy-as-code frameworks, and automated audit trails. With case studies spanning pharma (21 CFR Part 11), healthcare (GDPR), and financial services (KYC/AML), it validates the compliance-by-design approach — directly relevant to AmpleLogic's low-code aPaaS for life sciences quality and manufacturing.

Journal of Governance & Regulation (Alashaari, 2025)

Published in the Journal of Governance & Regulation (2025), this peer-reviewed study evaluates the effectiveness of statistical control charts (X-bar, S, and R charts) for pharmaceutical quality control at Avalon Pharma. Using sampling inspection data from Amaglime 2mg tablet production, it demonstrates how statistical process control methods improve product quality, detect process deviations, and support GMP governance — reinforcing the case for modern SPC software adoption in pharma manufacturing.

Asian Journal of Research in Chemistry (Mamatha, Ahad et al.)

Published in the Asian Journal of Research in Chemistry (2023), this paper reviews Out-of-Trend (OOT) detection and management strategies in pharmaceutical manufacturing — including regression control charts, slope control charts, and multi-time-point analysis. It highlights AmpleLogic's OOT Tracking Software built on low-code technology as a key tool for managing OOT discoveries across analytical, process control, and compliance alerts in stability studies and GMP quality assurance.

AAPS PharmSciTech (Yang, Lou & Chan)

Published in AAPS PharmSciTech (2026), this peer-reviewed paper proposes a USL-normalization method for pharmaceutical cleaning validation that standardizes residue measurements across multiple specification limits. It introduces the KDEDPonUSLND algorithm for robust nonparametric process capability analysis and presents AI-enabled Stage 3 Continued Cleaning Process Verification models — directly relevant to AmpleLogic's Cleaning Validation software for GMP-regulated pharma and biotech facilities.

Drug Discovery Today (Steinwandter, Borchert & Herwig)

Published in Elsevier's Drug Discovery Today, this peer-reviewed paper reviews data science applications across the biopharma lifecycle — from process development and scale-up through validation, routine manufacturing, and life-cycling (ICH Q12/CPV). It cites AmpleLogic eMBR as a key electronic batch records platform and covers AI/ML, digital twins, IoT, LIMS/MES/EBR integration, multivariate analysis, soft sensors, and DevOps strategies for Pharma 4.0 transformation.