Quality is paramount in Lifesciences and the pharmaceutical industry as it is directly associated to patient health and safety. As pharma companies struggle with slow quality management systems, AmpleLogic brings to you its first ever AI-based Pharmaceutical QMS Software.
Especially designed to cater to Biotech, Contract Research Organization (CRO), Medical Devices, Contract Development and Manufacturing Organization (CDMO), Active Pharmaceutical Ingredient (API) Manufacturers, Food & Beverages, Beauty & Cosmetics, Medical Devices, Gene Therapy other drug manufacturing businesses, the application uses BERT and LLaMa 3 technologies to amplify the Change Control process. Be it taking action for any deviation or other quality risks, AmpleLogic AI QMS solution assists QA, QC, Manufacturing and R&D tackle challenges head on and be audit-ready always!
Efficiently manage quality and ensure audit readiness
Clean and organized dashboard for quick and better module navigation
AI Change Control recommendation amplifies decision making and saves time
Advanced API integration for streamlined data collection and analysis
Choosing the right Pharma Quality Management Software is crucial for the regulated sector. AmpleLogic Pharma AI QMS solution complies with 21 CFR part 11, EU ANNEX 11, cGMP, ISO 9001:2005, ISO 14001, ISO 18001/45001, ISO 31000, GHGRP. It helps you identify and tackle deviations using OOS & OOT identification, CAPA and AI-based Change Control recommendation system. Measure Vendor qualification, manage audits and market complaints, report lab incidents and much more! Navigate complex regulations with AmpleLogic GAMP Pharma AI QMS solution.
Automatic alerts and prompts ensure quick authorization and closure
Ensures a secure and compliant environment for critical data assets
Configured to analyse unique business workflow
AmpleLogic Pharma eQMS ensures compliance with global regulations
Optimize quality management with faster risk analysis, faster change control management for addressal of any quality concerns
Get AI-recommended change control action plan and procedures for increased efficiency and elimination of redundancies
Speed up activity closure with superb change control AI recommendation feature. Close quality management processes within estimated timelines
Effectively save costs by 50% because of faster implementation of quality risk mitigation through AI change control system that in integrated within the AI QMS system
System’s layout is designed for easy and logical navigation with clear labels and consistent structure across all modules. Users can effortlessly switch between tasks without unnecessary clicks or confusion
Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance
Enhanced CAPA (Corrective and Preventive Action) capabilities provides methodical approach to inquiry, process mapping, and problem management. Also analyze the efficiency of CAPA
Access actionable insights instantly with real-time data analytics for informed decision-making and proactive quality management
Access actionable insights instantly with real-time data analytics for informed decision-making and proactive quality management
Identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process
Trend analysis for monitoring manufacturing process changes and take risk-based decisions
Ensures continuous improvement of processes with detailed quality management
Streamline quality management with a single sign-in, while role-based access ensures users see only relevant information, boosting efficiency and productivity
Get detailed insight on pending tasks with stage wise record and elaborate viewing history
Monitor unit/department productivity and efficiency through KPI-driven evaluation metrics and traceability trends
Easily integrates with ERP, SAP, MES, DMS, LMS, RIMS, LIMS, ERP, Legacy Systems and other third-party systems
All pharma quality management procedures are initiated, approved, assessed, and verified online with electronic signatures and activity stamps
Detailed tracking of workflows, processes, modules, and admin-level operations
Adaptable workflow, compliant with 21 CFR Part 11 and tailored to customer’s procedure
Satisfies electronic record standards of TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH
Compliant with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, ISO 9001:2005, ISO 14001, ISO 18001/45001, ISO 31000, GHGRP, etc
Implementation of EQMS System at Julphar Julphar (Gulf Pharmaceutical Industries), founded in 1980, is a leading pharmaceutical manufacturer based in Ras Al Khaimah, UAE. It
Implementation of Electronic Quality Management Solution (EQMS) at AL Andalous AL Andalous is one of the market leader pharmaceutical company in Egypt with the highest growth
Ind Swift Laboratories Goes Live with AmpleLogic Electronic QMS System AmpleLogic is delighted to announce the successful implementation of Electronic QMS System at Ind-Swift Laboratories Limited.
Industry-Specific Software for Enhanced Quality and Compliance
The pharmaceutical industry, particularly in Europe, faces an increasingly complex landscape. With regulatory pressures, evolving market demands, and the ever-present need for efficiency and quality,
In the pursuit of operational excellence and quality assurance, deviations from established norms are not just expected but anticipated. However, what truly differentiates successful organizations
Change control is a critical process in regulated industries, such as pharmaceuticals, medical devices, and food and beverages. It involves managing changes to products, processes,
A Quality Management System (QMS) is a formalized framework documenting processes, procedures, and responsibilities to achieve quality objectives and ensure compliance with regulatory standards.
AmpleLogic’s Quality Management Software is highly customizable, allowing companies to implement personalized changes that align with their unique business processes and address specific concerns.
AmpleLogic’s eQMS is a top choice for quality management in lifesciences, food & beverages (F&B), beauty & cosmetics, medical devices, and the gene therapy industry.
AmpleLogic’s ISO 9001 QMS software adheres to crucial international regulations, including US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, along with Alcoa+ Principles.
We provide customization benefits on all our COTS products including the QMS software. The application has been built keeping in mind the regulatory compliances of various industries around the globe. It provides seamless data and API integration, enhancing transparency and authorization; thereby improving audit quality.
Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.
QMS software is designed to streamline quality management processes and ensure regulatory compliance. Key features include document management, non-conformance tracking, CAPA (Corrective and Preventive Actions), audit management, risk management, training management, change control, supplier quality management, complaint handling, and quality metrics reporting. These features help organizations maintain product quality and operational efficiency.
Yes, AmpleLogic offers a cloud-based Quality Management System (QMS) software tailored for pharmaceutical manufacturing companies. It simplifies managing quality processes, helps meet GMP and FDA regulations, and improves product quality. Since it’s cloud-based, you can access it from anywhere, track real-time data, and securely store important information. It’s a practical solution that makes quality management easier and more efficient for your team.
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
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Annual Product Quality Review
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