AmpleLogic Quality Management System (QMS) is a web-based quality management software that provides an end to end solution to the organizations that enables to automate or eliminate paper-based the processes and integrating them across a single platform. This will bring exceptional transparency across all the systems and in resolving your issues down their roots.

1. GMP Compliance Software for Quality Operations
Quality Management System

2. AmpleLogic Quality Management System
QMS
CAPA
Change
Control
Market
Compliant
Audit
Management
Deviations
OOS/ OOT
Web based User Access
Control of GMP Process & Comply with 21 CFR Part 11
Requirements
Security at Process & Organization Level
Real time data information with Graphical Reports
Flexible enough to Support Changes on need basis
Send Alerts, Notifications and Escalations

3. QMS Features
Is fully configurable to adapt to your company’s specific business needs, providing flexibility, as well as
scalability, to support changes to fields, forms, workflows, and business rules and the ability to add future
applications.
✓ Integrates seamlessly with other Biometric, ERP, Document Management, LIMS, MES and other systems
✓ Forms to capture, track and report on various quality issues of observations, complaints, adverse events, deviations, non-
conformances, audit findings, conduct root-cause analysis and CAPA Process
✓ Reduce costs incurred by re-works, scrap, and process down times
✓ Robust reporting capabilities that includes a suite of reporting and trending tools & support both internal and external audits
✓ Reduce costs incurred by re-works, scrap, and process down times
✓ Adapt quickly to manufacturing changes, reduce time-to-market and Increase product quality

4. QMS Corrective Action and Preventive Action (CAPA)
PREVENTIVE ACTION
Prevent Nonconformity Occurrence
CORRECTIVE ACTION
Eliminate Detected Nonconformity
Decreases risk of product recalls, improves
product quality and safety.
Helps to ensure compliance, Reduces audit time,
uncover trends
Improve processes & solve process problems,
and provide new preventive actions.
Enable for any FDA, MHRA or other compliance
requirements audits
Easily configurable to meet your specific process
and automation needs.
Tracks incident and record the root clause of
CAPA, update effected SOP’s
Identification
(Define the Problem)
Impact/Risk Assessment
(Initial assessment of impact & problem)
Immediate Action
(Protect the customer from problem)
Root Cause Investigation
(Identify root cause of problem by
systematic approach)
Conclusion & Quality Decision
(Protect the customer from problem)
Action Plan
(Define corrective & Corrective action)
Implementation
& Follow up

5. QMS Corrective Action and Preventive Action (CAPA)
5
Detect
Analyze
Trend
Investigate
Identify Solutions
Communicate
Verify/Validate
Monitor Effectiveness
✓ Many Sources of
Quality Data
✓ Internal
✓ External
✓ Implement changes for
correction/prevention
✓ Take global actions
✓ Disseminate information
✓ Apply learning
✓ Measure effectiveness
✓ Management review
Apply risk
management
Records
People
Inputs
Outputs

6. QMS Change Control
CHANGE CONTROL PROCESS
Identification of Change
Request
Assessment of Change
Request
Analysis of Change
Request
Approval of Change
Request
Implementation of Change
Request
Manage changes to requirements across multiple sites, locations, and geographies
The submission of change requests and control plan revisions at any point in the production
process, with all revisions controls are tracked, ensures product quality, safety, and compliance.
Manage version control, workflow process
Comply with 21 CFR Part 11 Requirements, Audit Trails, E-Signatures etc.
Increases operational transparency through automated alerts, overall views using dashboard
functionality, and extensive reporting capabilities
Seamless integration to QMS Functionality such as CAPA and other quality activities

7. QMS Audit Management
Schedule
& Publish
Pre Audit
Activities
Post Audit
Activities
Difficult to generate accurate & timely reports using spreadsheets and
paper documents where auditor will not able to see the big picture of
organization audit program
Enables organizations to prepare for and enforce audit related
tasks and activities, enabling them to comply with regulations and
compliance requirements.
Determine whether records are complete, accurate, observation
of the processes and congruent according to regulatory
requirements
PROBLEM STATEMENT

8. QMS Deviation Management

9. QMS Market Complaint
Provides the complete documentation,
investigation and resolution of customer
feedback and complaints while ensuring
compliance to FDA , GMP Guidelines and
other Regulatory Requirements
Track, implement any requirements, reduce product recalls
and improve quality in product to ensure the compliance
requirement
Streamline & Automate market complaints management to
improve product quality and safety, lower audit time and
product recalls, decrease risk, and ensure FDA and
regulatory compliance requirements
In takes any market complaints to investigations, CAPA’s,
Deviations and ensure proper checks to ensure the product
quality and minimize the product risk
Centralize incident records, report results, investigations,
close cases and communicate to market people

10. AmpleLogic Out of Specification (OOS)
OSS
Acceptance
Review
Check List
Investigation
Verification
Identification
Evaluation
Closure
✓ Automatically creates the right CAPA at the right time by generating a new CAPA
to an existing CAPA record
✓ Continuous improvement in quality and manufacturing with robust reporting for
root cause analysis and identifying trends over time, including out-of-trend
(OOT) results
✓ Reporting with detailed investigation & results and reduce OSS Incidents
✓ Ensures product non-conformances are properly, investigated efficiently and
handled through the tracking process and managing from initial report, phases
of investigation, root cause analysis and any resulting in change controls and
Corrective Action and Preventative Actions (CAPAs)
✓ Initiate CAPAs based off of OOS investigations and manage supporting
documents,
✓ Reduce Non Conformances of products ensuring proper follow ups to take
CAPA process are completed
✓ Improves other quality and operating processes by integrating with any third
party systems

11. Any Queries?
Please Contact us: info@amplelogic.com
Visit Us : https://amplelogic.com/
Thank You