RegionAmpleLogic eQMS
AI-Powered QMS Software & Quality Management System for Pharma
Transforming Pharmaceutical Quality Management with AI
AI-Powered APQR Software
Annual Product Quality Reviews, Reimagined with AI
Annual Product Quality Review is a critical regulatory requirement for pharmaceutical and life sciences organizations. AmpleLogic’s APQR solution enables structured, compliant, and inspection-ready reviews by consolidating quality data, automating trend analysis, and generating audit-ready reports.
Trusted by 100+ Pharma Companies Globally
Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Life Sciences
Benefit from GMP solutions customized for life sciences, Pharma, R&D, biotech etc.
Cannabis
Enhance cannabis and tobacco manufacturing with advanced software for efficiency.
Medical Devices
Transform the medical device industry with software that enhances compliance.
Gene & Cell Therapy
Transform gene therapy with advanced software for precision and efficiency.
Food & Beverages
Enhance food and beverage manufacturing with software for efficiency and operational agility.
Cosmetics
Boost cosmetics and beauty operations with innovative software for process optimization.
Case Studies
Embrace Quality Excellence with AmpleLogic AI-based QMS System
Looking for a robust, AI-driven QMS software or QMS system tailored for pharmaceutical companies? AmpleLogic’s quality management system offers intelligent automation, regulatory compliance, and process optimization — all in one platform.
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!
Commitment to AI-Powered Excellence
AI-based Change Control Recommendation
Get AI-recommended change control action plan and procedures for increased efficiency and elimination of redundancies
Manage Quality & Audit
Efficiently manage quality and ensure audit readiness
Integration Capabilities
Advanced API integration for streamlined data collection and analysis
Regulatory Compliance
AmpleLogic Pharma eQMS ensures compliance with global regulations
Features of Quality Management System (QMS Software)
Quality Management Optimization
Optimize quality management with faster risk analysis, faster change control management for addressal of any quality concerns
Speed up Activity Closure by 70%
Speed up activity closure with superb change control AI recommendation feature. Close quality management processes within estimated timelines
Save Costs by 50%
Save costs by up to 50% through faster implementation of quality risk mitigation using an AI-driven change control system integrated within the AI QMS System.
Easy Navigation
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
Audit Management
Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance
CAPA Capabilities
Enhanced CAPA (Corrective and Preventive Action) capabilities provides methodical approach to inquiry, process mapping, and problem management. Also analyze the efficiency of CAPA
Real time Insights
Access actionable insights instantly with real-time data analytics for informed decision-making and proactive quality management
Visual Reports
Identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process
Trend Analysis
Trend analysis for monitoring manufacturing process changes and take risk-based decisions
Continuous Improvement
Ensures continuous improvement of processes with detailed quality management
Single Sign-in & Role Based Access
Streamline quality management with a single sign-in, while role-based access ensures users see only relevant information, boosting efficiency and productivity
Pending Task & Viewing History
Get detailed insight on pending tasks with stage wise record and elaborate viewing history
Quality and Performance Metrics
Monitor unit/department productivity and efficiency through KPI-driven evaluation metrics and traceability trends
Seamless Integration
Easily integrates with ERP, SAP, MES, DMS, LMS, RIMS, LIMS, ERP, Legacy Systems and other third-party systems
Reviewed and Verified Processes
All pharma quality management procedures are initiated, approved, assessed, and verified online with electronic signatures and activity stamps
Real-Time Record
Detailed tracking of workflows, processes, modules, and admin-level operations
Customization Benefits
Adaptable workflow, compliant with 21 CFR Part 11 and tailored to customer’s procedure
Electronic Record Standard
Satisfies electronic record standards of TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH
Compliant to Global Regulations
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
Switch to AmpleLogic AI eQMS Solution
Choosing the right Pharma QMS is vital for compliance. AmpleLogic’s AI-powered QMS meets global standards like 21 CFR Part 11, EU Annex 11, and ISO certifications. It streamlines OOS/OOT detection, CAPA, AI-driven Change Control, vendor qualification, audits, complaints, and lab incidents. Simplify regulatory challenges with AmpleLogic’s GAMP-compliant solution.
Quality Related Challenges in Pharma
Quality Related Challenges in Pharma
Ensuring adherence to regulations and guidelines like 21 CFR PART 11, EU ANNEX 11, cGMP, GLP, GCP, and others, while maintaining data integrity and accuracy, is crucial for achieving compliance standards, quality assurance, and patient safety.
Data Integrity Issues
The pharmaceutical industry faces challenges such as data manipulation, system errors, or glitches while retrieving data. These issues can impact both internal and external audits, ultimately affecting overall quality management.
Supply Chain Challenges
Managing raw material quality, ensuring supplier compliance, and addressing logistical challenges are vital. Supply chain disruptions risk delaying manufacturing, compromising product quality, impacting compliance.
Product Recalls & Non-Conformance
Unexpected product quality failures, adverse drug reactions, or manufacturing defects may lead to product recalls. Recalls can damage brand reputation, incur financial losses.
Technology Integration
Pharma businesses often find trouble in getting their hands on the best integrated software for quality management. This slows down processes or leads to inaccurate fetched data, thus affecting audits and hinders decision making.
Departmental Communication
There is a lack of communication between pharma R&D, manufacturing, quality assurance, regulatory affairs, and supply chain teams that affects quality management and causes troubles during audits.
Case Studies
Why Choose AmpleLogic QMS Software for Pharma?
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.
Quick Prompts & Alerts
Automatic alerts and prompts ensure quick authorization and closure
Data Integrity
Ensures a secure and compliant environment for critical data assets
Workflow Configuration
Configured to analyse unique business workflow
Regulatory Compliance
AmpleLogic Pharma eQMS ensures compliance with global regulations
Our compliance
Why Choose us?
Our compliance-first, AI-enabled platform is designed to meet the rigorous demands of regulated industries, enabling faster application.
10X Faster Deployment
Our platform accelerates solutions, reaching markets 10x faster.
ROI in 3 Months
Low-code solutions deliver fast deployment, cost savings, & quick ROI.
98% Project Rate
Experience a 98% success rate, surpassing the industry average of 56%
Domain Expertise
We deliver tailored solutions, ensuring business growth and lasting success
Challenges with Traditional APQR
Fragmented Data Across Multiple Systems
Manual Consolidation & Spreadsheet Dependency
Inconsistent Formats & Review Practices
Limited Visibility into Quality Trends
Increased Inspection & Compliance
FAQ’s
Get Answers to All Your Queries
A Quality Management System in life sciences helps companies manage documents, training, audits, and CAPAs while ensuring compliance with global regulations like FDA 21 CFR Part 11, GxP, and ISO 13485.
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.
Which Industries Does AmpleLogic’s eQMS Cater To?
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.
