Root Cause Analysis with example for “5” Why technique
Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root
AmpleLogic eQMS
Electronic Quality Management System
Transforming Quality Management for Regulated Industries
Unlock Quality Excellence with AmpleLogic Pharma QMS
AmpleLogic cloud-based Pharma QMS solution is tailored for Pharmaceutical, 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. It assists QA, QC, Manufacturing and R&D tackle deviations with real-time insights, excellent integration, comprehensive change control and CAPA. Streamline supplier management, manage costs, market complaints and product recalls with continuous improvement and be audit ready always!
Manage Quality & Audit
Efficiently manage quality and ensure audit readiness
Intuitive Dashboard
Clean and organized dashboard for quick and better module navigation
Mobile-Friendly
Enables seamless quality management from any device, anytime, anywhere
Integration Capabilities
Advanced API integration for streamlined data collection and analysis
Quality Related Challenges in Pharma
Regulatory Complexity
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 and compliance.
Supply Chain Challenges
Managing the quality and consistency of raw materials, ensuring supplier compliance, and addressing logistical disruptions. Any supply chain break can compromise product quality, delay manufacturing, and disrupt distribution, impacting compliance and patient safety.
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, and result in regulatory penalties.
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.
Why Choose AmpleLogic eQMS?
Choosing the right Pharma Quality Management Software is crucial for the regulated sector. AmpleLogic Pharma 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 Change Control. Measure Vendor qualification, manage audits and market complaints, report lab incidents and much more! Navigate complex regulations with AmpleLogic GAMP Pharma 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
Explore the Capabilities of AmpleLogic Pharma QMS
Discover the robust features that make, AmpleLogic QMS a pinnacle in quality management
Quality Management
Manage quality efficiently with proper analysis and addressal of issues and quality concerns
Deviation Management
Gain insights into the root cause of variances by tracking and analyzing deviations
Risk Mitigation
Mitigate risks effectively under the quality risk management system, ensuring proactive identification and resolution of potential issues
Audit Management
Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance
Comprehensive Module Suite
Amplify Quality Management with CAPA Tracking, Change Control, Market Complaints, Deviation Management, Audit Management, Vendor Qualification, OOS, OOT and Lab Incident Reporting
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
Return on Investment (ROI)
Delivers measurable cost savings and productivity improvements, offering strong return on investments
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
Real time Insights
Access actionable insights instantly with real-time data analytics for informed decision-making and proactive quality management
Built-in Emailing Feature
Enhances communication with customers and regulatory authorities
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
Cloud based Technology
Offers flexibility and secure access from anywhere, eliminating the need for extensive IT infrastructure and ensuring your quality control is always available
Scalable
Designed to scale with your business, adapting to increased production, regulatory changes, and new products while ensuring consistent quality and compliance
Round-the-Clock Accessibility
Web-based application ensures 24x7 end-user access to a secure centralized database
Enhanced Visibility
Timeline visibility to handle major and minor issues saving resources and time
Activity Closure Timelines
Activity Closure timelines with and without extensions
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
No Geographical Hindrances
As a web-based solution, AmpleLogic Pharma QMS eliminates geographical hindrances
Enhanced Transparency
Web-based access ensures openness and detailed traceability throughout Integrated Quality Systems
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
Bharat Biotech implements AmpleLogic’s eQMS for seamless quality control and compliance management – Download the full report!
Modules
Navigating Excellence Through Integrated Modules
AmpleLogic eQMS
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Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Articles
Integration of Artificial Intelligence and Machine Learning in QMS
Integration of AI & ML in Quality Management Systems There is no doubt that we have entered the new industrial revolution, commonly referred to
AmpleLogic: Offering GMP Quality Management System to Achieve Optimum ROI
The aging population, chronic and lifestyle diseases, emerging-market expansion, and treatment and technology advances are expected to spur life sciences sector growth in 2015. Furthermore,
Frequently Asked Questions
What is QMS?
A Quality Management System (QMS) is a formalized framework documenting processes, procedures, and responsibilities to achieve quality objectives and ensure compliance with regulatory standards.
How is AmpleLogic’s eQMS Software Tailored for Your Company?
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 eQMS is a top choice for quality management in lifesciences, food & beverages (F&B), beauty & cosmetics, medical devices, and the gene therapy industry.
Does AmpleLogic’s QMS System Comply with International Regulations?
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.
What makes AmpleLogic’s eQMS software unique?
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.
In Which Geographical Areas Do We Offer Our Solutions?
Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.
What are the features of QMS Software?
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.
Does AmpleLogic offers Cloud based QMS Software?
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.
Contact us
Your Pharma Automation Starts Here
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:
Your benefits:
- Client-oriented
- Independent
- Competent
- Results-driven
- Problem-solving
- Transparent
What happens next?
1
Schedule a call at your convenience
2
Discovery and consultation session
3
Get your custom proposal
