AmpleLogic Annual Product Quality Review (APQR) Reviews & Product Details - Page 2

AmpleLogic APQR stands out as a cutting-edge solution for the pharmaceutical, API, CDMO, Biotech, and Bio-sciences industries, addressing the crucial need for Annual Product Quality Review (APQR/PQR/APR). Complying with the stringent requirements outlined in the current good manufacturing practices (CGMP) regulations, particularly 21 CFR 211.180(e), AmpleLogic APQR is designed to streamline and fortify the APQR process. The software adheres to the guidelines set by regulatory bodies such as the FDA, ensuring that products following US FDA protocols and GMP standards are thoroughly reviewed before being distributed in the United States markets. AmpleLogic APQR/PQR Software, built on a LOW-CODE AND NO-CODE (LCNC) PLATFORM, distinguishes itself by seamlessly capturing and consolidating information manually while also interfacing with other software systems like LMS, QMS, BMS, and MES/eBMR. By aligning with the principles established in ICH Q7 2.5 Product Quality Review 2.50 and EU GMP standards, AmpleLogic APQR facilitates the verification of manufacturing consistency, trend analysis, and identification of necessary changes in specifications or production techniques. This innovative software ensures that pharmaceutical companies can efficiently manage their Annual Product Reviews, enhancing the overall quality control processes within the organization.