The document discusses the need for an automated document management system in the pharmaceutical industry. It outlines challenges with manual document management including lack of control, complex retrieval and archiving. An automated system would facilitate collaboration, improve regulatory compliance, and provide features like version control, workflows, and role-based access to address these issues. The solution presented includes templates, numbering, searching, and integrations with quality and manufacturing systems.

2. PROBLEM STATEMENT
Pharmaceuticals industries are in a highly regulated environment and
require effective document management process. With increasing amount
of documents pharmaceutical companies deal with below issues:
• Little control on the accessibility of the document
• Tedious process in case of obtaining approval and signatures
• Retrieving information requires manual search
• Indexing and archiving is complex, costly and time-consuming
• Larger documents restrict mobility
• Tracking down any document activity is difficult
• Short shelf life and difficult to recover
• Non uniform date and signature entry
• Illegible writing
Manual Document
Management Process

3. BENEFITS OF AUTOMATING DOCUMENT MANAGEMENT PROCESS
Facilitated Collaboration
Improve access to
Records & Information
Reliable Backups &
Reduce Queue Time
Improved Regulatory
Compliance
Enhanced Document
Security & Control Easier Retrieval
& Search

4. CONNECTING DOCUMENTS AND SOLUTION FEATURES
AMLPELOGIC FEATURES
TYPES OF DOCUMENTS
Specification
& STPs / GTPs
SOP Protocols
Batch Master
Copies
Validation
Master Plan
Site
Master Files
Apex
Documents
Forms /
Annexure
Analytical
Sheets
Raw Data
Sheets
APQR DPRs
Document Template Number Format
Version Control Document Comparison
Search and Retrieval Document Collaboration
Workflows Watermark & Overlays
Print Controls Document Issuance
DOCUMENT
MANAGEMENT
SYSTEM
Document Archival Role Based Access

5. DETAILED DOCUMENT MANAGEMENT SYSTEM FEATURES
Document Format
Create & define header,
footer, cover & approval
page etc.
Document Template
Define and upload uniform
template for different
document types
Number Format
System generated document
number based on document
type, plant and department
Document Comparison
View entire document
revision and version tree to
compare document content
Print Controls
Print or download different
document copies i.e.,
controlled, training, draft etc.
Search and Retrieval
Advanced search for getting
access to documents
immediately
Reports & Dashboards
Custom reports to provide
real time status of document
activities and updates
Version Control
Records version and
revision of document
created or updated
STANDARD FEATURES ADDITIONAL FEATURES CUSTOM COMPONENTS
Workflows
Manage and define workflow
for routing of documents i.e.,
for review and approval
Role-based Access
Manage access rights for
documents based on users
roles & responsibilities
Document Archival
Move documents to
Archival Library after a set
period of time
Document Collaboration
Share document with
colleagues for collaboration
and review
Document Issuance
Records are maintained for
issuing any document with
sign & date
File Formats
Support multiple file
formats including word,
excel, pdf, image etc.
Watermark & Overlays
Define and print watermark
for different document
copies
Document Tagging
Attach multiple supporting
documents for document
types i.e., Annexure, Form
Integration
Integrate with Active
Directory, ERP and other
Quality Operation Systems
Document Security
Configurable security settings
to control document at
different levels i.e.,
department, site etc.
Types of Document
Categorize document based
on GMP & non-GMP etc.

6. 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

7. Solution Integration for coherent business processes
Document Management System in the pharmaceutical industry cannot be a ‘stand alone’ independent software, it
has to seamlessly integrated with the quality management system, manufacturing systems, Electronic batch
manufacturing records and various other electronic documents that are generated in the manufacturing process.
QUALITY SYSTEMS MANUFACTURING SYSTEMS

8. 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

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

10. Our Customers
Pharma and Biotech
Non Pharma

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