Annual Product Quality Review System (PQR/APQR)

AmpleLogic PQR software revolutionizes product quality review for Pharmaceutical, API (Active Pharmaceutical Ingredient) Manufacturers, Contract Development and Manufacturing Organization (CDMO), Biotech, Biosciences and Contract Research Organization (CRO) Industries. Generate Annual Product Quality Review (PQR) reports and CPV reports anytime as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). AmpleLogic APQR software follows established protocols of US FDA and GMP standards. ICH Q7 2.5 proposes regular quality reviews of APIs, which are referred to as Product Quality Reviews (PQRs) in EU guidelines for Good Manufacturing Practice (GMP)

Annual Product Quality Review System (PQR/APQR)

AmpleLogic PQR software revolutionizes product quality review for Pharmaceutical, API (Active Pharmaceutical Ingredient) Manufacturers, Contract Development and Manufacturing Organization (CDMO), Biotech, Biosciences and Contract Research Organization (CRO) Industries. Generate Annual Product Quality Review (PQR) reports and CPV reports anytime as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). AmpleLogic APQR software follows established protocols of US FDA and GMP standards. ICH Q7 2.5 proposes regular quality reviews of APIs, which are referred to as Product Quality Reviews (PQRs) in EU guidelines for Good Manufacturing Practice (GMP)

Annual Product Quality Review System (PQR/APQR)

AmpleLogic’s AI-Powered Annual Product Quality Review (APQR) software is designed to help pharmaceutical companies stay audit-ready at all times by transforming the way Product Quality Review (PQR) and Continued Process Verification (CPV) reports are generated. Industry data shows that 7 out of 10 pharma organizations fail audits because of inaccurate or incomplete PQR reporting, often caused by poor integration across manufacturing, quality control, and legacy data systems. AmpleLogic addresses these challenges with a cloud-based, software-as-a-service (SaaS) platform that combines advanced data visualization, real-time analytics, and automated process tracking to meet global regulatory requirements, including current Good Manufacturing Practices (cGMP) and 21 CFR 211.180(e). The system simplifies the collection of critical manufacturing and quality data, ensures data integrity, and eliminates inconsistencies that can compromise compliance or product safety. Its optical character recognition (OCR) capability extracts information from physical documents, while an integrated AI chatbot provides instant access to any data point, enabling faster decision-making and immediate audit response. Predefined report templates let users generate accurate PQR and CPV reports on demand, significantly reducing manual effort and human error. By continuously monitoring key process parameters, AmpleLogic’s APQR solution safeguards product quality, supports regulatory adherence, and strengthens overall organizational credibility in the highly regulated pharmaceutical industry.

Annual Product Quality Review System (PQR/APQR)

AmpleLogic’s AI-Powered Annual Product Quality Review (APQR) software is designed to help pharmaceutical companies stay audit-ready at all times by transforming the way Product Quality Review (PQR) and Continued Process Verification (CPV) reports are generated. Industry data shows that 7 out of 10 pharma organizations fail audits because of inaccurate or incomplete PQR reporting, often caused by poor integration across manufacturing, quality control, and legacy data systems. AmpleLogic addresses these challenges with a cloud-based, software-as-a-service (SaaS) platform that combines advanced data visualization, real-time analytics, and automated process tracking to meet global regulatory requirements, including current Good Manufacturing Practices (cGMP) and 21 CFR 211.180(e). The system simplifies the collection of critical manufacturing and quality data, ensures data integrity, and eliminates inconsistencies that can compromise compliance or product safety. Its optical character recognition (OCR) capability extracts information from physical documents, while an integrated AI chatbot provides instant access to any data point, enabling faster decision-making and immediate audit response. Predefined report templates let users generate accurate PQR and CPV reports on demand, significantly reducing manual effort and human error. By continuously monitoring key process parameters, AmpleLogic’s APQR solution safeguards product quality, supports regulatory adherence, and strengthens overall organizational credibility in the highly regulated pharmaceutical industry.