Quality Management System Software for Pharma - AmpleLogic - PowerPoint PPT Presentation

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Quality Management System Software for Pharma - AmpleLogic

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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. AmpleLogic QMS will comply with all US FDA regulations such as 21 CFR Part 11 requirements, EU Annexure, MHRA, ISO and other regulatory standards – PowerPoint PPT presentation

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Title: Quality Management System Software for Pharma - AmpleLogic


1
Quality Management System
GMP Compliance Software for Quality Operations
2
Elements of Quality Management System
Out of Specifications
Out of Trends
Incident Management
Market Complaints
Deviations
CAPA Management
Change Management
Audit Management
Vendor Qualification
Quality Management System
Copyright_at_ 2019 AmpleLogic
www.amplelogic.com
3
QMS Features helps you to Grow and Save
Real Time, Web Based Collaboration audit
trails
21 CFR Part 11 Compliance other standard
regulations
Configurable Triggers, Escalation Track
Role Based Security or Permissions
Integrates with ERP, third party or exiting
systems
End to End Reporting, Graphical Analytical
Reports
Workflow Configuration, Configurable Form Builder
with simple drag drop
Connects with Biometric, Active Directory or any
legacy systems
Key Features of AmpleLogic QMS
Copyright_at_ 2019 AmpleLogic
www.amplelogic.com
4
Benefits of AmpleLogic Quality Management System
  • Improve Auditing capabilities
  • Capturing all auditable events
  • Decrease time spends in Audits and Reduce costs
  • Enhance decision making based on readily
    accessible data or reports for analysis
  • Enhance communications with all levels of
    employees, customers suppliers
  • Ensure timely process tracking with a automated
    workflow
  • Minimizes administration and configuration
    burdens
  • Enables users to control security

www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
5
QMS Corrective Action and Preventive Action
(CAPA)
PREVENTIVE ACTION Prevent Nonconformity Occurrence
CORRECTIVE ACTION Eliminate Detected Nonconformity
Identification (Define the Problem)
Decreases risk of product recalls, improves
product quality and safety.
Impact/Risk Assessment (Initial assessment of
impact problem)
Tracks incident and record the root clause of
CAPA, update effected SOPs
Immediate Action (Protect the customer from
problem)
Helps to ensure compliance, Reduces audit time,
uncover trends
Root Cause Investigation (Identify root cause of
problem by systematic approach)
Improve processes solve process problems, and
provide new preventive actions.
Conclusion Quality Decision (Protect the
customer from problem)
Enable for any FDA, MHRA or other compliance
requirements audits
Action Plan (Define corrective Corrective
action)
Easily configurable to meet your specific process
and automation needs. 
Implementation Follow up
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
6
QMS Change Control
Benefits
Identification of Change Request
Real Time Triggers for approvals, rejections,
change execution Submit Change requests and
control revisions at any point on the process of
production and keep track all versions Empower
all employees with access to change requests,
work flow changes and updated process Flexible
Agile work flows, form, metrics and views are
configurable without IT Depency Reduced
timelines or cycle time and costs
Assessment of Change Request
Analysis of Change Request
Approval of Change Request
Implementation of Change Request
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
7
QMS Audit Management
Gain comprehensive, real-time visibility into
audit findings
Proactively identify and resolve risk areas,
non-conformities, and deviations
Streamlines the process automate recurring tasks
Secure, Instant decision making process to reduce
CAPAs
Enhance audit productivity and efficiency and
reduce risk of errors
Enhance internal teams to find out strengths
weakness in the process
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
8
QMS Deviation Management
  • Integrates with quality process of CAPA, Change
    Control etc.
  • Manage, Support, Track planned unplanned
    deviations
  • Identify the trends of deviation occurrence
    through sites, code, errors etc.
  • Triggers alerts based on deviation types
  • Permission based reporting on real time to
    analyze the findings
  • Tracks historical deviations for inspection if
    any
  • Ensure high secure, control while maintaining the
    compliance
  • Decreases risks of repeat issues and errors by
    improving root cause analysis 

www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
9
QMS Market Complaint
  • Centralize, record incidents/ results ,
    investigations and Communicate to market people
  • Track and manage customer logs to CAPAs,
    Investigations process
  • Improve Product Quality, simply event reporting
  • Reduce the Product recalls, ensure compliance
  • Streamlines entire compliant life cycle processes

Provides the complete documentation,
investigation and resolution of customer feedback
and complaints while ensuring compliance to FDA ,
GMP Guidelines and other Regulatory Requirements
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
10
QMS Out of Specification (OOS)
Initiate CAPAs based off of OOS
investigations Creates the right CAPA at the
right time by generating a new CAPA to an
existing CAPA record Reduces risks of repeated
OOS non conformances with proper follow
ups Improved OOS Closure timelines Fast-track
investigations prevent customer shipment delays
and ensure product quality Reduces risk of lost
or incomplete data through closed-loop OOS
process
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
11
QMS Vendor Qualification
  • Managing the process of evaluating, selecting,
    monitoring vendors and supply chain partners
  • Improved collaboration with vendors in resolving
    problems with supplied goods
  • Improve the efficiency of the suppliers
    distribution network with automated workflow
  • Tracked complete visibility of supplier issues,
    performance, defects found during inspection at
    the source in manufacturing
  • Manage, avoiding recurring issues and problems by
    reviewing across the network
  • Increase oversight on suppliers automatically
    depending on their quality performance increase
    sampling rates and audit frequency
  • Support for planning product and inspection
    specifications, including product
    characteristics, tolerances, and rules for
    sampling, oversight and audits

www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
12
THANK YOU
United Kingdom (UK)
Canada
India
Spain
Singapore
USA
Email us info_at_amplelogic.com
www.amplelogic.com
Copyright_at_ 2019 AmpleLogic
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