QMS

Venkanna software Services Pvt. Ltd , A Registered Company operates under brand name AmpleLogic
Amplelogic QMS Modules
AmpleLogic Pharma QMS (also knows as web QMS), A 21 CFR PART 11 and EU Annex 11 complaint software and CGMP
Quality Management Solution enables organization to automate their paper-based Business Processes and integrate them
across a single platform. This brings an exceptional transparency across Quality Systems and in resolving quality issues down
their roots. The system has been developed to be flexible in adapting quickly with compliance to regulatory standards like
US FDA, WHO, MHRA and be diverse across a wide range of customers, maximizing benefits of reducing the Quality Costs

Amplelogic
QMS Modules
Amplelogic QMS Features
• Data Integrity and Centralized Database ( For ex: Only the latest SOP will be available at all locations etc…).
•
• Facilitate compliance with FDA regulations 21 CFR Parts 11 and ISO quality standards.
• Automation and streamline the paper process to increase the Operational efficiency.
• Customer Satisfaction in terms of Process Transparency and effective communication.
• Avoiding the Physical document movement and making them available online with Role based access results in immediate
approvals/ decision making.
• Responsibility matrix effectively followed. Well defined automated Process Implementation (System workflow will take care of
required approvals, feedback /Communications etc…)
• Automated preventive Alerts and regular email follow-up’s to ensure in time completeness(CAPA due date reminders, Vendor
Re-Assessment dates, Approval delays etc..)
• Less efforts in tracking and Traceability, So the Quality team can focus more on process Improvement areas (Like repeated
Audit findings, Best Practices from One Unit can be implemented in other units etc…).
• Less clerical work results in fewer chances for mistakes.
• Define Key Performance Areas and Can Track them in order to Improve process .
• Move towards environmental friendly Organization (Less paper work, more automation).
• Custom MIS Reports (Automated Trending) to check the Unit/Department Productivity and Performance.
Amplelogic Successful Engagement Approach

Production Deployment
Initial Run User Acceptance Validation
& Support

Meetings with Business
user’s
Initial Gaps finding during
demo of Pre configured
Application.
Configuration based on
Initial Requirements/Gaps
Software Installation
User training
Enter the current data
Compare the System
generated templates with
Annexures
Requirements Finalization
SOP Revision if Required.
Re-Configuration to
accommodate detailed
Requirements.
Reporting Requirements
User Training
Functional Requirements
update.
Validation Plan and
IQ/OQ/PQ documents
update and Approval
UAT (User Acceptance Test )
Sign off
Re- Configuration based on
Initial Phase inputs.
Role and access rights
definition
Building Traceability across
modules
Reports customization
User Training Manual
User Training
Execution of Validation
Activities (IQ/OQ/PQ)
Closure of Validation
Observations
Final Version Installation
Application Access to all
Users
User Training for 2 months
Real time Data Entry
Move from Manual to
Automated System
Support Definition

We could able to achieve Our Success Rate @100%

Standard Features of the Modules

8 times faster than

21 CFR Part 11 EU annexure 11 Centralized data Graphical, intuitive and
conventional approach,
Compliance Compliance repository analytical reports
follows visual modelling

Role base access along with Automated email Metrics Reporting and 24*7 Web based Easy integrations with
e-Signature and audit trail notifications, reminder Analytical Trending access existing SAP, ERP and other
and escalations systems.
Our Pharma Customers

6
Our Non Pharma Customers
 Thank You

Any Queries? Please Contact us: info@amplelogic.com

Visit Us : www.amplelogic.com