SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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AmpleLogic Regulatory Information Management System
AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.
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AmpleLogic Quality Management
AmpleLogic's Quality Management Software (eQMS) is intricately crafted to meet the rigorous requirements of heavily regulated industries. The ISO 9001 certified cloud-based Quality Management System (QMS) is ideal for Lifesciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and analogous sectors. As businesses acknowledge the challenges associated with manual quality checks—prone to both laborious efforts and errors—they are increasingly adopting QMS software solutions. These systems play a pivotal role in enhancing audit quality through process automation, efficient data management, and seamless API integration.
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AmpleLogic Learning 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.
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