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 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.
Excel quality management with proper deviation identification and mitigation
Eliminating manual efforts in document management and tracking
Manage audits efficiently to take informed regulatory decisions
Advanced API integration for streamlined data collection and analysis
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.
AmpleLogic eQMS ensures compliance with global regulations
A module suite encapsulating CAPA, Change Control, Market Complaints, etc
Ensures a secure and compliant environment for critical data assets
Configured to analyse unique business workflows
Discover the robust features that make, AmpleLogic QMS a pinnacle in quality management
Manage quality efficiently with proper analysis and addressal of issues and quality concerns
Gain insights into the root cause of variances by tracking and analyzing deviations
Mitigate risks effectively under the quality risk management system, ensuring proactive identification and resolution of potential issues
Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance
Access intuitive visual representations to swiftly identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process
Amplify Quality Management with CAPA Tracking, Change Control, Market Complaints, Deviation Management, Audit Management, Vendor Qualification, OOS, OOT and Lab Incident Reporting
Ensures continuous improvement of processes with detailed quality management
Access the platform with single sign in enhancing efficiency
Web-based application ensures 24x7 end-user access to a secure centralized database
Track average closure time duration, stay updated on the latest document changes—all through intuitive graphical representations
Timeline visibility to handle major and minor issues saving resources and time
Activity Closure timelines with and without extensions
Data is secure and free from manipulation and loss
Quick response time for faster decision making in improving processes
Trend analysis for monitoring manufacturing process changes and take risk-based decisions
Get detailed insight on pending tasks with stage wise record and elaborate viewing history
Easy customization based on your requirements
Easily integrates with MES, DMS, LMS, RIMS, LIMS and ERP systems for streamlined operations
Role-based access to fit the hierarchy chart from department to designation to employee profile
Improved process management and business communication, minimizing user mistakes
Automatic preemptive alerts, prompts, and escalations for prompt authorization and closure
All QMS procedures are initiated, approved, assessed, and verified online with electronic signatures and activity stamps
Detailed tracking of workflows, processes, modules, and admin-level operations
Enhances communication with customers and regulatory authorities
As a web-based solution, AmpleLogic QMS eliminates geographical hindrances
Web-based access ensures openness and detailed traceability throughout Integrated Quality Systems
Compliant with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc
Streamline Corrective and Preventive Actions (CAPA) efficiently, ensuring continuous improvement and compliance.
Manage changes seamlessly, ensuring controlled modifications to processes, documents, and systems.
Effectively address and manage customer complaints, ensuring swift resolutions and customer satisfaction.
Identify, document, and manage deviations from standard processes, minimizing risks and ensuring compliance.
Facilitate efficient and comprehensive audits, ensuring adherence to regulatory requirements and industry standards.
Streamline vendor qualification processes, ensuring only qualified and reliable vendors are part of your supply chain.
Address and manage situations where product specifications deviate, ensuring product quality and compliance.
Monitor and manage trends that fall outside expected parameters, ensuring proactive quality management.
Enable prompt reporting and management of incidents, fostering a proactive approach to quality and safety.
Manage product recalls efficiently, ensuring swift actions to protect consumers and maintain compliance.
Identify, assess, and manage quality risks across processes, products, and systems.
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,
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
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.
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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