This document describes various quality management system modules provided by AmpleLogic, including CAPA, change control, deviation management, audit management, vendor qualification, and market complaints. For each module, it discusses regulatory requirements, problems with traditional manual systems, and key features of AmpleLogic's computerized solutions. The solutions provide features like electronic records, signatures and audit trails, integration between modules, and automated notifications and reports. AmpleLogic is an established quality management software provider that works with many global pharmaceutical companies.

2. AMPLELOGIC QUALITY MANAGEMENT SYSTEM
CAPA Change Control Deviation
Market
Complaints
Vendor
Qualification
Audit
Management
OOS / OOT
QUALITY
MANANGEMENT
MODULES
Integrated Modules
21 CFR PART 11
Compliance
Web Based Solution

3. QMS MODULE - CAPA
PROBLEM STATEMENT
Regulatory Requirement (FDA)
CAPA MODULE
The purpose of the corrective and
preventive action system is to collect
information, analyze information, identify
and investigate product and quality
problems, and take appropriate and
effective corrective and/or preventive action
to prevent their recurrence
FDA has published “Guide To Inspections of
Quality Systems” (often referred to as
“QSIT”) where they tell you how they will
conduct an inspection.
 Extensive follow-up is required to determine status and ensure the
CAPA is progressing
 The process is difficult to execute consistently due to a lack of
control
 Incomplete forms and/or mistakes in completing the forms
 Reporting and analysis is very labor intensive
 Difficult to determine the bottlenecks in the process
 Lack of accountability from employees due to lack of management
visibility
 Delay in closures because there is no proper navigation of tasks
and no stringent follow ups in manual process
 As all the task are defined by TCD, there is no proper notification,
reminder or escalation process in manual activity which delays the
planned action
 No proper collaboration between cross functional teams
 Lack of expertise to determine the definition of CAPA and Root
Cause

4. QMS Module - CAPA
APPROACH TO CREATING A RISK BASED CAPA PROCESS
AmpleLogic CAPA Tracking Software investigates systems intricately in order to find errors and problems. This software also helps
in solving these problems by identifying them and taking necessary corrective measures to prevent any future re-occurrence
21 3 54 6 87 9 1110 12 1413 15
INQUIRY AND ASSESSMENT PRE-INVESTIGATION INVESTIGATION PLANNING AND
EXECUTION
REVIEW AND VERIFICATION
Create CAPA request and submit for review. Identify sources of CAPA worthy issue
Review CAPA request. Determine whether or not issue requires CAPA investigation
Accept or reject CAPA request
If accepted, issue and initiate CAPA
Finalize CAPA sources (i.e., products, processes)
Determine CAPA cross-functional team
Identify any immediate actions and corrections required
Investigate and capture findings
Determine root cause(s)
Specify corrective and/or preventive action plan
Complete action plan
Review CAPA for completeness
Approve CAPA actions
Specify steps for effectiveness verification
Verify effectiveness of CAPA
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5. QMS MODULE - CAPA
CAPA
Integrated with other QMS modules
KEY
FEATURES
Create CAPAs and link to root cause
Route Investigation & CAPA plan for approvals
Track completion and verification of each CAPA
Measure effectiveness according to the plan
Automated CAPA process
Easy distribution of task
Automated Email Alerts,
Notifications, Reminders
and Escalations
Complete Traceability with
E-signatures, audit trails and
Log activity information
21 CFR Part 11 and EU
Annex 11 Compliant
Configure to meet your
internal processes or
requirements
Built in reports, graphs and
analytical tools

6. QMS MODULE – CHANGE CONTROL
Material (Raw &
Packaging Material)
Production
Engineering
Changes Reported by
Change Management
Process
Research & Development Quality Control
Quality Assurance
Information Technology
Cleaning Procedure
 Poor Turnaround for change implementation, as company relying on manual
system require more time and effort to route and check submissions and
change orders.
 Lack of communication between departments, failure to follow up or escalate
change request
 Not having flexibility to adapt according to the dynamic changes of regulatory
bodies.
 Ineffective documentation as in manual process it is more difficult to find/
retrieve necessary data, update document to support the change.
 Training not integrated with Change
 No integration between the other modules of QMS
PROBLEM STATEMENTRegulatory Requirement (FDA)
All changes should be made according
to approved (approval implies
successful testing or through review/
investigation) written company policies
and procedures.
Any change in the production and processes must be
controlled meaning recorded, reviewed and approved by
the QC unit.

7. QMS MODULE – CHANGE CONTROL
Guideline for the
Establishment of a
Change Control Procedure
Change Request Initiation
Change Request Evaluation
Change Control Committee
(CCC) Evaluation
Change Request Approval
Change Implementation
Review and Verification
Close Change and
Effectiveness Check
Features of AmpleLogic Change Control Management Software
Structured and consistent approach towards managing change
Documentation of change approvals and implementation
Documenting the details of change
Impact Analysis of the Change Control Record
Checklist for Impact Assessment of Changes
Post Change and Effectiveness monitoring of change
Complete Traceability
with E-signatures, audit
trails and Log activity
information
21 CFR Part 11 and EU
Annex 11 Compliant
Configure to meet
your internal
processes or
requirements
Built in reports, graphs
and analytical tools
Seamless Integration to
Document Management,
Learning Management
and other QMS Modules
Automated Email Alerts,
Notifications, Reminders
and Escalations

8. QMS MODULE – DEVIATION MANAGEMENT
PROBLEM STATEMENT
Paper based system can result in excessive downtime and poor turnaround in
identifying, resolving deviations.
REGULATORY REQUIREMENT (FDA)
Critical deviations should be
investigated, the investigation
and its conclusion should be
documented
Written procedures should be
established and followed for
investigating critical deviations
or the failure of batch of
immediate or API to meet
specifications.
Any deviation from established
procedures should be
documented and explained.
Deviations from approved
standards of calibration or critical
instruments should be investigated
to determine if these could have an
impact on the quality of the
intermediate or API manufactured
TYPES OF DEVIATION
PLANNED
DEVIATION
UNPLANNED
DEVIATION
Poor deviation tracking during the course of a product development
Difficult to look for trends as there can be multiple variables involved in the
occurrence of a single deviation
Paper based systems are inherently time-consuming and it can significantly
hamper in their efforts to respond effectively on the multiple levels.
Difficult to track action plans and assigned tasks to address issues and raised
CAPAs
Ineffective risk analysis and investigation which can result in unidentified risks
for users, customers, employees, the organization.
Lack of data visibility among quality and regulatory team members to consider
the impact on other batches

9. Initiate Quality Risk Management
Risk Identification
Risk Analysis
Risk Evaluation
Risk Assessment
Risk Reduction
Risk Acceptance
Risk Control
Review Events
Risk Review
Result of Quality Risk Management
RISKCOMMUNICATION
Identify Immediate actions / corrections
Event Detection
Complete Initial DetailsRaise Deviation
Deviation Categorization
Minor Major Critical
Root Cause Investigation
Identify Corrective and Preventive Actions (CAPA)
Close
Access Risk
Effectiveness Check
QMS MODULE – DEVIATION MANAGEMENT
5 WHY
FLOW CHART
FACTOR ANALYSIS
TREE DIAGRAM
FISHBONE
DIAGRAM
PARETO CHART

10. QMS MODULE – DEVIATION MANAGEMENT
Features of AmpleLogic Deviation Management
Complete Traceability
with E-signatures,
audit trails and Log
activity information
21 CFR Part 11 and
EU Annex 11
Compliant
Built in reports,
graphs and
analytical tools
Seamless
Integration to other
QMS Modules
Automated Email
Alerts, Notifications,
Reminders and
Escalations
DEVIATION
HANDLING
ROOT CAUSE
INVESTIGATION
RISK
MANAGEMENT
Record Deviation details & affected areas/ process
Record investigation details & action plan for risk mitigation
Built-in root cause analysis tools
Product or Batch impact mapping
Linking with repeated deviations based on company workflow
Monitor deviation status & closure
Dynamic deviation reports to check the dependency

11. QMS MODULE – AUDIT MANAGEMENT
 Inefficient scheduling as manual methods and spreadsheet are at
disadvantage when scheduling audit calendar and notifying concerned
departments on the schedule.
 Traceability and archiving of past audit reports.
 Difficulty in audit collation as audit is conducted within different segment of
the organization and each area of operation has its risks and challenges.
 Missing Audit Observations and Findings
 Compromised security in ensuring confidentiality and limited distribution of
audit reports
PROBLEM STATEMENT

12. Pre-Audit
Process
&
Activity
Audit Planning and
Audit Preparation
Audit
Initiation
Audit Schedule acceptance
by Auditor and Auditee
Audit Confirmation /
Publish
Develop an Audit Plan
Prepare Pre-Audit
Questionnaire
Review Background
Information
Review Operational
Information
Develop On-site Questionnaire
and Audit Protocols
Select Departments for
communication
On-Site
Process
&
Activity
Post Audit
Process
&
Activity
Audit Observation
Recording
Audit Response
Recording
Document Review Detailed Site Inspection Review Audit Evidence Audit Findings and HOD review
Audit finding acted
upon (CAPA & Tracking)
Audit Finding action item
implementation review
Audit Findings Closure Audit Closure
Collate Information and
follow up
Prepare the Audit Report
Circulate Draft Audit
Report for Comments
Audit Compliance
Report
TYPES OF AUDIT
QMS MODULE – AUDIT MANAGEMENT
MASTERS
CONFIGURATION
Departments
Division / Plant
Approve Plan and Checklist
Internal Audit
External Audit
Vendor Audit
• Scheduled
• Un-Scheduled Auditee Users
Group
Auditor Users
Group
Audit Calendar
Audit Checklist
Yearly
Audit Planner
Audit Certificate

13. QMS MODULE – AUDIT MANAGEMENT
Complete Traceability
with E-signatures, audit
trails and Log activity
information
21 CFR Part 11 and EU
Annex 11 Compliant
Built in reports, graphs
and analytical tools
Seamless Integration to
other QMS Modules
Automated Email Alerts,
Notifications, Reminders
and Escalations
Features of AmpleLogic Audit Management
Audit planner (Quarterly/Monthly/Yearly) and Audit Calendar serve as a useful tool for Audit scheduling
Auditee can be informed about the audit schedule through automated alert and email notification
While scheduling the audit the concerned departments can be communicated on the agenda of the
audit
Approval mechanism in the AmpleLogic Audit Management solution allows for senior management’s
vigilance on the audit program
AmpleLogic solution also has qualitative rating system (Minor/Major/Critical) to note the severity of
audit observations
A certificate for internal auditor can be generated within the solution acknowledging the competence
of the auditor which is critical in performing the audit

14. PLANT AGREEMENTQUALITYDELIVERY RAW MATERIALHQ
PROBLEM STATEMENTQUALITY MANAGEMENT SYSTEM
VENDOR QUALIFICATION
Manual entry of data such as material details, sample details, trial supply is subject to error
Collecting and collating evaluation comments from QA/QC at different stages such as sample
collection, trial supply or on vendor questionnaire becomes quite a challenge
Maintaining paper based documents for Vendor like Registration form, License details,
Certificate of Analysis, Material Master becomes a daunting task for purchasing department
Not dealing with situations of vendor non-conformance in a timely and effective manner
Identifying an effective, reliable and selection of most profitable vendors for raw materials
supply
The selection, qualification, approval
and maintenance of suppliers of
starting materials, together with
their purchase and acceptance,
should be documented as part of the
pharmaceutical quality system

15. VENDOR SELECTION
PROCESS
PRELIMINARY
ASSESSMENT
Procurement
Quality
Assurance
PRE-PURCHASE
OF SAMPLES
Raw
Material
Questionnaires
Sample Testing
Quality Control
ANALYSIS OF
PRE-PURCHASED
SAMPLES
PERFORMANCE
STUDY
QC TESTING
AUDIT
VENDOR
APPROVAL
SAMPLING OF
STARTING MATERIAL
QUALIFICATION AND
CERITICATION OF THE
VENDOR
VENDOR
MONITORING
VENDOR
RATING
QUALITYASSURANCEQUALITYRISKASSESSMENT
Samples
Analysis Report
Certify Vendor
Batch
Vendor Audit
Final Product
VendorTrial
Supply
QMS MODULE – VENDOR QUALIFICATION
performance
measurement
Continuous
Quality Delivery
Service
Assessment

16. QUALITY MANAGEMENT SYSTEM
VENDOR QUALIFICATION
Material Masters
Features of AmpleLogic Vendor Qualification
Complete Vendor Information can be recorded
into the solution and provision for uploading
registration, certification and other relevant
documents received from vendorsVendor Registration
Vendor Re-Qualification
Vendor Monitoring
Vendor Investigation
Vendor Questionnaire and batch sample
management
Integration with Audit
Management
AmpleLogic Vendor Qualification solution also
allows for registering details of trial supply such
as, Material name and category, trial supply
period, observation on trial supply etc
Vendor Analysis and Assessment can be done
based on complete data available in the
repository
Quality metric tools such as Vendor Quality
Score, Sample Evaluation Quality Score, and
Quality Score Average

17. QMS MODULE – MARKET COMPLAINTS
PROBLEM STATEMENT
Manual Market
Complaints are
outdated and not
flexible.
Disconnect and
incomplete
Information
Lack of Analytics
Changing
Regulatory
Environment
Inconsistent
Complaint
Handling

18. Complaint
Initiation
Preliminary
Investigation
Source of Complaint
Details of Complainer
Product Information
Nature of Complaint
Complaint Category
Review of Complaint
& Start Technical
Investigation
Complaint Sample
Control Sample
Sample Review
Feedback to
Customer or
Complainer
Detailed Investigation
Out of specification (OOS) Report
Complaint
Closure
Return or
Reimbursement
Corrective
Actions (CAPA)
Correction actions
depending on the
nature of complaint
and its incidence
Monthly Reports
And Trending
Previous History Review Manufacturing Record Review Packaging Record Review
Analytical Record Review Stability Data Review Incident Report
QMS MODULE – MARKET COMPLAINTS

19. QMS MODULE – MARKET COMPLAINTS
Separate screens and details capture for initiation, preliminary investigation
and detailed investigation
Inbuilt feature to generate the investigation report and detailed investigation
report
Complaint categorization based on severity, probability and detectability
Detailed checklist availability as a part of investigation
Analyzing the dependency on other processes like stability, batch packing,
batch manufacturing to name a few also
21 CFR Part 11 and
EU Annex 11
Compliant
Automated Email
Alerts, Notifications,
Reminders and
Escalations
AmpleLogic provides a secure and centralized platform for receiving customer complaints and storing all subsequent
documentation pertaining to investigation and correction of the complaint
Configure to meet
your internal
processes or
requirements
Complete Traceability
with E-signatures,
audit trails and Log
activity information
Built in reports,
graphs and
analytical tools
Seamless
Integration to other
QMS Modules
Features of AmpleLogic Market Complaints

20. REGULATORY
COMPLIANCE
FEATURES
AmpleLogic solutions are compliant
to meet the requirements of
regulatory bodies like FDA’s 21 CFR
Part 11, EU Annex, MHRA etc.
Audit Trial
Digital / Electronic Signature
Access Authentication
Record Audit
Copies of Records
View History

21. QUALITY MANAGEMENT SYSTEM – INTEGRATED MODULES

22. Yet to Launch
eQMS
(Quality
Management)
DMS
(Document
Management)
LMS
(Learning
Management)
BIMS
(Batch Record
Issuance)
eBMR
(Electronic
Batch Record)
DATA
eLogs
(Electronic Log Book)
QC Planning
QM
(Quality Metrics)Regulatory
Changes
New / Update
Document
Training Needs
Batch Master Records
GMP Training
Records
Production Data
Statistical Analysis
eLogs
Data
Performance Indicators
Samples / Stability
Schedules
AmpleLogic single platform solution allows easy integration between different solutions, while
minimizing the cost of third-party integrations.
Launched
eLogs Data
QMS + Training
Data
RIMS
(Regulatory Information
Management) APQR
(Product Quality
Review)
Training
Material
Training Effectiveness
Record
Standalone computer
management
ERP SystemsUser Management
SINGLE PLATFORM – INTEGRATED SOLUTIONS

23. 2010 Operations Started in Hyderabad India
2012 First GMP Implementation of Audit Module using LOW CODE PLATFORM
2014 ISO 9001-2015 Certification
Associated with 10 leading pharma companies for DMS and QMS implementations
Signed up with 7 leading Pharma Companies2015
2016 Recognized by CIO review magazine and Silicon India for unique delivery models
Launched QC automation modules and LMS solution
2017 Associated with 25 US FDA/MHRA/WHO approved Plants
2018 Finalist in CPHI Worldwide Awards, Entry into Egypt and UAE Markets
Foundation to develop new modules like APQR, Product Recall, ANDA & DMF tracker
Started working on draft Quality Metrics guidelines by USFDA
2019 US Market entry, Appreciated by 7 customers during audit on our Paperless automation
120 Young Engineers, 10,000 Sq. feet offices and 3 channel partners
Road map to add more flexibility to eBMR/MES, eLogs
About AmpleLogic
Trusted
by
35+ Pharma
&
20 Non Pharma
Companies across
Globe

24. Pharmaceutical Business Process - Ready to Use Modules
16 6 6 7 17 1 2
No of Implementations
Yet to Launch

25. WHY AMPLELOGIC?
Application Components
Customized Workflow
Role based Access
User Management
Organization Hierarchy
Application Session Management
Temporary Role Management
Robust Form Creation
Data Template for Migration
Record Data Validation Checks
No Limit for Characters in form fields
Up to 300 Mb file upload
Easy Import and Export of records
Support Multiple Document Formats
User Features
Customizable Reports and Dashboards
Automated Notification
User Specific Calendar
Schedules Reminders
Adaptable to mobile & tablet Interface
Electronic Signature for approvals
Multi Lingual (UI) Interface Available
Login & Password Polity Check
Management Features
User Permissions and Restrictions
Alert & Escalation Management
Powerful Graphical Analytical Reports
Rule Enforcements
Schedule Configuration
Compliance Features
Integration Components
Integration with Active Directory
Integration with other Quality Solutions
Integration with ERP i.e, SAP, Oracle etc.
Biometric Access & Integration
Audit Trail
Activity Stamp i.e, Date, time & user
Two Step Authentication
Record Audit
View History
“Our Solution are build on LOW CODE Platform
providing faster implementation cycles & ease
of configuration under (GAMP4, GAMP5)”

26. Our Customers
Pharma and Biotech
Non Pharma

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