LMS

QMS
DMS LMS

Trackers QMS

Quality Metrics eBMR

DMS
AmpleLogic Pharma Focus

AmpleLogic software is  Road map to add more flexibility to eBMR/MES

trusted by 30 pharma
companies across the
globe.
 Foundation to develop new modules like APQR, Product Recall, ANDA & DMF tracker
2018
 Started working on draft quality metrics guidelines by USFDA
 AmpleLogic is paperless; Appreciated by 5 customers during audit
 Achieved 97% project success rate till date

 Launched DMS new version

 Signed up with 7 leading pharma companies 2017
 4 QC, 2 LMS, 8 DMS and 5 QMS implementations
 ISO 9001-2015

 4 QMS and 10 DMS implementations

 Launched QC automations and LMS 2016
 Awarded by CIO review magazine

 Associated with 10 leading pharma companies

for DMS and QMS implementations 2014
 Launched stability module

 Foundations for Quality Management and BMR

 First GMP implementation in FDA approved 2012
plant

• Started operations in Hyderabad India. 2010

Pharmaceutical Business Process - Ready to Use Modules

QMS LMS
 Deviations • GMP and Non GMP Learning
Management
 CAPA
• Skill Development
 Change Control
• Training Calendar
 Audits (Internal/External and Vendor)
DMS LMS  Market Complaints • Centralized Training
 Vendor Qualification
 OOS Quality Metrics
 OOT
• Quality Index and Metrics
 Product Recall
• Facility Index and Metrics
 APQR
QMS • QMS Dashboards KPA wise
Trackers
• Organization Performance Metrics

Trackers DMS

• Documents Management
 Calibration Schedules and Out of • Document Issuance
Quality Metrics eBMR Calibration Management • Document Comparison
 HPLC Column Management • Separate Workflows for protocols,
 Standards (Primary/Reference and SOP’s, Templates and Annexures
working ) Trackers
 Stability Schedules eBMR
 DMF Tracker
 ANDA Tracker • Drag and Drop Master copy
generation
• Online recording of Batches
• Production Batched Dashboard
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 Automated email Metrics Reporting and 24*7 Web based Easy integrations with
with e-Signature and notifications, reminder Analytical Trending access existing SAP, ERP and
audit trail and escalations other systems.
AmpleLogic – Tweaked V Model to Bridge the Gap
AmpleLogic has tweaked traditional V Model to accelerate GMP
Automations and to address the data integrity issues with their
unique Low Code Platform by adding the Configuration and
Experimentation Sub phase in the User Requirement Phase of the V
Model.

This approach helps in realizing the requirements before

finalization of the Functional Requirements, business user’s will be
clear on the software outcome. This will also addresses the
regulatory audit observations related to revalidation, deviations
and multiple release managements.

Requirement Gaps can be easily identified during configuration

and experimentation phase thus, implementation time is reduced
and allows to complete OQ in 25% of the total project time.

Configuration and Experimentation sub phase in the

implementation cycle will address the regulatory audit observations
related to revalidation, deviations, multiple release managements
and longer implementation times can be reduced by 70%.
Our Recognition for this innovation CPHI Worldwide 2018 as finalist https://awards.cphi.com/finalists/
Proven Case studies on our Product/Application Services using
LOW CODE with configuration and Experimentation

• QMS : Our world class QMS has 12 Implementations, competes with

Global players like Trackwise, Metric stream, Master control

• LMS : Our LMS (Learning management) system, Comparable with

Saba and Sumtotal.

• DMS : Our DMS (Document Management) Software is the best fitment

to Pharmaceutical Industry with 6 Implementations , Currently In the
evaluation process to replace world’s largest DMS Company
http://www.expressbpd.com/pharma/cover-story/tweaking-v-model-to-accelerate-gmp-
automations-and-address-data-integrity-issues/401446/

www.expressbpd.com/pharma/digital-issue-pharma/express-pharma-vol-13-no-14-may-16-30-
2018/401456/
Why to Choose Us?

Low Code Development Platform Fixed Cost

AmpleLogic No Code/low Code Platform offers Strong knowledge in pharmaceutical domain
pharma companies to automate and manage allows us to deliver the solutions at fixed cost
quality and compliance processes with one with no hidden charges.
solution

97% project success Rate

Unique Requirements Amplelogic solutions delivery success rate is
Every unique requirement from the customer 97% against the IT industry average of 56%
will be treated as challenge, resulting in
adding more components to our No Code
Platform.

Visual Modelling approach

Customizable Reports
Powerful, easily customizable dashboards and
Excel reports helps in quick decision making
Visual modelling approach with drag and drop
functionality allows the business user’s to see
the application while making

Amplelogic is paperless company. We automated ourselves before advising customers on automations.

Amplelogic Successful Engagement Approach

Validation Production Deployment &

Initial Run User Acceptance
4 weeks Support
2 weeks 2 weeks
4 weeks

Meetings with business user’s Requirements finalization
Initial gaps finding during demo of SOP revision if required.
pre-configured application/ Ready
to use modules Re-configuration to
accommodate detailed
Configuration based on initial requirements.
requirements/ gaps
Reporting requirements
Software installation
User training
User training
Functional requirements update.
Enter the current data
Validation plan and IQ/OQ/PQ
Compare the system generated documents update and approval
templates with annexures
UAT (User Acceptance Test ) Sign
off
Re-configuration based on initial Final version installation
phase inputs.
Application access to all users
Role and access rights definition
User training for 1 month
Building traceability across
modules Real time data entry
Reports customization Move from manual to
automated system
User training manual
Support definition
User training
Execution of validation activities
(IQ/OQ/PQ)
Closure of validation
observations

Our unique approach allowed us to achieve the Success Rate of 97 %

Our Pharma Customers

11
Our Non Pharma Customers
Thank You
Visit Us : https://amplelogic.com/

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