AmpleLogic Regulatory Information Management System

AmpleLogic’s Learning Management System (LMS) is designed to organize and monitor a vast number of GMP and Non-GMP training for life sciences, pharmaceutical manufacturing, API (Active Pharmaceutical Ingredient) Manufacturers, contract development and manufacturing organization (CDMO) biotechnology, and contract research organizations (CROs), including SOP, technical, HR, external, and research training. AmpleLogic Pharmaceutical Training Management Software aids in determining training requirements depending on a user’s Role. It’s also possible to create a department-specific training calendar, carry out and assess various forms of employee training programs, guarantee compliance through appropriate tracking, and keep training records annually with the creation of reports for management review.

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content