Exploring Deviation Investigation Tools
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
AmpleLogic eQMS
Electronic Quality Management Software
Transforming Quality Management for Regulated Industries
Unlock Quality Excellence with AmpleLogic eQMS
AmpleLogic offers a cloud-based eQMS solution tailored for highly regulated industries like Life Sciences, F&B, Beauty & Cosmetics, Medical Devices, Gene Therapy, etc. Our Electronic Quality Management Software tackles industry challenges head-on with transformative deviation management providing real-time insights, excellent system integration and comprehensive CAPA, change control, OOT, OOS modules.
Streamline Quality Management
Excel quality management with proper deviation identification and mitigation
Efficient Documentation
Eliminating manual efforts in document management and tracking
Audit Management
Manage audits efficiently to take informed regulatory decisions
Integration Capabilities
Advanced API integration for streamlined data collection and analysis
Why Choose AmpleLogic eQMS?
In highly regulated environments, choosing the right Quality Management Software (QMS) is crucial. AmpleLogic’s QMS, an ISO 9001 certified cloud-based solution helps you in identifying and tackling deviations using CAPA, Chage Control, OOS & OOT identification and handling, lab incident reporting modules and much more! Navigate complex regulations with AmpleLogic QMS software that ensures quality and compliance.
Regulatory Compliance
AmpleLogic eQMS ensures compliance with global regulations
QMS Modules
A module suite encapsulating CAPA, Change Control, Market Complaints, etc
Data Security
Ensures a secure and compliant environment for critical data assets
Workflow Configuration
Configured to analyse unique business workflows
Unleashing the Power of
AmpleLogic 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
Manage deviations
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
Visual Insights for Every Module
Access intuitive visual representations to swiftly identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process
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
Continuous Improvement
Ensures continuous improvement of processes with detailed quality management
Single Signed Access
Access the platform with single sign in enhancing efficiency
Round-the-Clock Accessibility
Web-based application ensures 24x7 end-user access to a secure centralized database
Real time Insights
Track average closure time duration, stay updated on the latest document changes—all through intuitive graphical representations
Enhanced Visibility
Timeline visibility to handle major and minor issues saving resources and time
Activity Closure Timelines
Activity Closure timelines with and without extensions
Maintains Data Security
Data is secure and free from manipulation and loss
Response Time
Quick response time for faster decision making in improving processes
Trend Analysis
Trend analysis for monitoring manufacturing process changes and take risk-based decisions
Pending Task & Viewing History
Get detailed insight on pending tasks with stage wise record and elaborate viewing history
Customization Benefits
Easy customization based on your requirements
Seamless Integration
Easily integrates with MES, DMS, LMS, RIMS, LIMS and ERP systems for streamlined operations
Organogram
Role-based access to fit the hierarchy chart from department to designation to employee profile
Improved Processes
Improved process management and business communication, minimizing user mistakes
Quick Alerts and Prompts
Automatic preemptive alerts, prompts, and escalations for prompt authorization and closure
Reviewed and Verified Processes
All QMS 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
Built-in Emailing Feature
Enhances communication with customers and regulatory authorities
No Geographical Hindrances
As a web-based solution, AmpleLogic QMS eliminates geographical hindrances
Enhanced Transparency
Web-based access ensures openness and detailed traceability throughout Integrated Quality Systems
Compliant to Global Regulations
Compliant with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc
Modules
Navigating Excellence Through Integrated Modules
AmpleLogic eQMS
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Articles
Challenges of Change Control in a Regulated Industry
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 Comprehensive Insight on Various Audit Types in Quality Management
Quality audits specifically examine how well product designs and processes meet specified standards and regulatory compliances. They are performed periodically by internal people within the
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.
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 convenienceÂ
2
Discovery and consultation session
3
Get your custom proposal
