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.

Modules

Navigating Excellence Through Integrated Modules

AmpleLogic eQMS

CAPA Management Software

Streamline Corrective and Preventive Actions (CAPA) efficiently, ensuring continuous improvement and compliance.

Change Control Management System

Manage changes seamlessly, ensuring controlled modifications to processes, documents, and systems.

Market Complaints Management

Effectively address and manage customer complaints, ensuring swift resolutions and customer satisfaction.

Deviation Management

Identify, document, and manage deviations from standard processes, minimizing risks and ensuring compliance.

Audit Management Software

Facilitate efficient and comprehensive audits, ensuring adherence to regulatory requirements and industry standards.

Vendor Qualification Management

Streamline vendor qualification processes, ensuring only qualified and reliable vendors are part of your supply chain.

Out of Specification

Address and manage situations where product specifications deviate, ensuring product quality and compliance.

Out of Trend

Monitor and manage trends that fall outside expected parameters, ensuring proactive quality management.

Incident Reporting Software

Enable prompt reporting and management of incidents, fostering a proactive approach to quality and safety.

Product Recall

Manage product recalls efficiently, ensuring swift actions to protect consumers and maintain compliance.

Quality Risk Management

Identify, assess, and manage quality risks across processes, products, and systems.

March 19, 2024

Julphar Replaces Manual QMS with AmpleLogic EQMS

Implementation of EQMS System at Julphar Julphar is one of the largest pharmaceutical manufacturers in the Middle East, Headquartered in Ras Al Khaimah, United Arab

February 13, 2024

AL Andalous Case Study – Digital QMS Software

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

February 13, 2024

eQMS System implementation at Ind-Swift Laboratories Ltd

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.

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Life Sciences

Benefit from GMP solutions customized for life sciences, pharmaceuticals, R&D, biotech etc.

Food & Beverages

Enhance food and beverage manufacturing with software for efficiency and operational agility.

Medical Devices

Transform the medical device industry with software that enhances compliance.

Cannabis

Enhance cannabis and tobacco manufacturing with advanced software for efficiency and flexibility.

Gene Therapy

Transform gene therapy with advanced software for precision and efficiency.

Cosmetics

Boost cosmetics and beauty operations with innovative software for process optimization.

Articles

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

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

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.

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: