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Digital Transformation forHealthcare & Life Science
www.newgensoft.com
Agenda
CEO Top Priority
Source: PWC 2015
Growing Challenges
• Highly Document Intensive
• Ever Changing Regulatory Compliances
• Visibility across all Processes
• Scaling process and operations
• Monitoring Productivity, SLA, TATs
• Change & Transition management
Newgen Overview
1200+ Customers
1 of 3 vendors to feature
in MQs for
iBPMS, ECM & CCM
58Countries
200+ Partners
1600+Employees
100+ Healthcare Customers globally
40+Patents
World’s largest ECM Project in Insurance Sector with
9 Billion docs
ECM MQ
“Visionary Quadrant”
Investors
Offices
Singapore
USA • Florida• Washington DC
Canada
UK
UAE
India• New Delhi• Mumbai• Chennai
Industry Recognized Product Portfolio
Gartner MQ for Enterprise Content Management
Gartner MQ for Intelligent Business Process Management Suites
Gartner MQ for Customer Communication Management
Gartner MQ for Case Management Report
Global Presence: Marquee Customers
BFSI
Finance
BPO & Shared Services
Health Care &
Life Sciences
Newgen Product Portfolio
Product Logical Architecture
Straight Through
Process
Heads Down Production
Process
Collaborative Human
Process
Semi Structured
Process
Fully Unstructured
Process
1 2 3
Gateways
• Web Services
• JMS
• Web APIs
• UI Integration
• Advanced
Terminal Emulator
Integration
Adaptors
iBPMS Components
Process Initiation
Fax Event Scan
MobileEmail Portal
Process Execution
Engine
Business Activity
Monitoring
Social Media
Integration
Process
Modeler
Content
Management
Process
Simulator
Mobile
Integration
Adaptor
Business Rules
Management
System
CEP Analytics
Newgen Solution
iBPM ECM
Process Accelerators
Content Capture
Appeals & Grievances
Quality & Manufacturing Process
Employee On-Boarding
Art Work Management
Provider Contracting
Patient Record Mgmt
Infrastructure
Database ServersConnectivity
Procure To Pay Record To Report F&A Processes
Legacy Applications
Pharma: Solution Accelerators
Goods Manufacturing Process
Document Lifecycle Management
• Standard Operating Procedure (SOP)
• Master Formula Record (MFR)
• Master Packaging Record (MPR)
• Batch Manufacturing Record (BMR)
• Batch Packaging Record (BPR)
Batch Production Process
Artwork Management Process
Promotional Material Process
Close Loop Marketing
Healthcare Payer: Solution Accelerators
Member Enrollment
Provider Contracting
Appeals & Grievances
Claims Management
Solution Accelerators for Hospitals
Document Lifecycle Management
• Legal Contracting and Maintenance
• F&A Documents Management
• Electronics Customer Health Records
• Central SOP Repository
• Records Management
• Document Acquisition Management
• Patient Record Management
Electronic Medical Record
Complaints Management
Consent Management
Customer Communication Management
Finance and Accounts
• Transactional• Accounts Payable (AP) or Procure-To-
Pay (PTP)
• Accounts Receivable (AR) or Sales-Order-To-Cash (SOTC)
• PO Approval
• Order to Cash
• Collections
• General Ledger (GL) or Records-To-Reports (RTR)
• Fixed Assets Management (FA) or CAPEX Management
• Tender Processing / Quotation Management
• Freight Bill Processing – Inward & Outward
• Master Data Management• Vendor Master
• Price Master
• Item Master
• Vendor/Consultant Agreements
• Lease & Agreements
• Query Resolution• Vendor Query Management
Human Resources
• Employee Reimbursements• Travel & Expense
• Medical Claims
• PL Encashment
• Advance Request
• Payroll Additions/ Deductions
• Leave Management
• Contract Management
• Hire-to-Retire• Indent
• On boarding
• Ongoing Appraisals
• Exit Formalities
Admin
• Service Request Process
• Travel desk Management
• Suggestion Scheme Process
SSC: Process Accelerators
Quality & Manufacturing Solution for Pharmaceuticals
Cost of GMP* Non-Compliance
Leading Pharmaceutical Drug
Manufacturer found non -
compliant to GMP standards
by FDA
73 out of 125 drugs put on
Consent Decree list by FDA
Production suspended for
drugs on list
Nearly $250 million lost in
profits for a single drug on the
decree list in 1 year
$500 million paid out in fines
* GMP refers to Good Manufacturing Practices
Source:
1. BioPharm International, “After the Consent Decree – An Uphill Battle for Affected
Companies”, 1 Jun 2004, http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=102280
2. © 2011, Daratech, Inc, Cambridge, MA, USA Reference. 8.178 (charts-ecmppv-pie-1.gif)
$1,000,000Production Interruptions
Cost per day due to halted production
Consent Decree Fines for failing to comply with GMP or other
federal requirements
$50-500 mn
$5 to $975K
Legal Finesfor violations of environmental
regulations by manufacturing facilities
GMP Compliance - Challenges and Risks
Difficulty in managing myriad types, multiple versions
and large volumes of pharmaceutical documents
Inaccurate documentation produced during Regulatory
Audits for GMP Compliance
Regulatory Warnings & Denial of Drug Entry into Market
Drug Revenue Loss
Newgen Quality & Manufacturing Solution for Pharmaceuticals
• Complete Document Lifecycle Management
• Out of Box compliance with FDA 21 CFR part 11 regulations
• Increased productivity and quicker employee TBR training on
SOP documents
Document Lifecycle
Management
• Ensured right document delivery at various production steps
• Controlled access to all documents from single repository Strong Checkpoints for Batch
Production
• Fast access to documents and document audit details
required during GMP compliance auditsCompliance Desktop
Newgen Solution Features
Newgen Solution Feature Set
Content Creation
Dictionaries and Taxonomies
Document Templates
Auto-Naming/Linking
Content Lifecycle Management
Workflow
Task Notification
Change Control
Version Management
Content Transformation
PDF Rendering
Overlay
Watermark
Controlled Printing
PDF Annotation
Content Compliance
Electronic Signature
Audit Trail
Search
Reporting Dashboards
Support for 21 CFR Part 11
Document Lifecycle Management
Document Authoring
Document
Review
Document
Approval
Quality Check
Effective and Revised Versions
Controlled
Document
Usage
Automated workflow for online
document review-approval
Flexible workflow definition
System managed document
states Draft, In Review, At Approval, QA
Pending Release, Effective,
Superseded
Automatic PDF rendering &
watermarking of document
Automatic document version
management
Controlled document access &
printing
Configurable document
related states, types and
metadata
HOD Initiates Document Creation
HOD
• Initiates document creation
• Captures document details (metadata)
• Select workflow for review –approval of draft document
Author Checks Out Document Template
Author
• Checks out document template for creating draft
• Checks –in, e-signs and submits draft document for review
21 CFR Part 11 Compliant
Solution satisfies CFR 21 part 11
requirements for e-signatures
Documents e-signed using
unique combination of username
and password at each stage of
document creation/revision
lifecycle
Signatures appended to
document contain:
Name of signer
Data and time of executing
signature
Reason for executing signature
21 CFR Part 11 Compliant
Signatures appended to
document contain
Name of signer
Reason for executing
signature
Data and time of
executing signature
Reviewer –Approver Annotates Document Rendition
Reviewer/Approver
• Review draft document rendition
• Specify review comments using annotations
• Send document back to author/ send forward for Approval & QA check
Two Document View
• Reviewer can view previously annotated document and newly corrected document sent
by author side by side
Quality Assurance User Sets Effective Date
Quality Assurance User
• Perform final check of document rendition
• Specify review comments using annotations
• Send document back to approver/ set effective date for document
View List of Recently Effective Documents
Strong Checkpoints for Batch Production
Process Order received
Automatic
check for
availability of
correct batch
production
documents
Production documents attached for
batch production
Documents watermarked
and batch number
recorded on Documents
Document Issued to
Production for printing and
usage
Documents Scanned and archived in
system after production completion
Ensure right document delivery at drug production checkpoints
System Controlled Document Delivery for Batch Production
Batch number attached to document issued to production user
Compliance Desktop for Document Access
• Instant online document access using Full Text Search and Advanced meta data search
• Controlled access and printing of documents
• Quick access to document audit details for compliance audits
Access Document Audit Trails
System maintained audit trails
about all document related user
actions including:
Authoring
Check-out/Check-in
Rejection
Review, Approval
Revision
Download/Printing
Single point access to all
document versions
Case Study - Strides
Challenges
• Standardization of location specific requirements
• Need of better visibility and control over their manufacturing practices
• Integration with Legacy documents archived through Parallel Scanning Exercise
• Flow of hard copies of controlled documents used to increase operational costs
Benefits
• Increased visibility of the issuance process for manufacturing
• Controlled flow of documents online
• Timely automated system alerts/escalations
• Watermarking
• Automated checking of Manufacturing License before issuance to production
Profile
• World’s largest Soft gelatin capsule manufacturer
• Leading manufacturer of niche pharmaceutical and nutritional products
Processes Automated
• Product Permission (Drug License) Process
• Master Formula Record (MFR)
• Master Packaging Record (MPR)
• Batch Manufacturing Record (BMR)
• Batch Packaging Record (BPR)
• Issuance and Execution of Process Orders from SAP
Our Approach
• Platform - not a Point Solution
• Scale Processes Locations Users
• Out of box Template process (L1 , L2 & L3)
• Pro-agile Implementation methodology (prototypes)
• Map customer requirement using graphical Process Modeler
• Configurable real time monitoring platform
Envisaged ROI from Digitization
Digitization
Productivity Optimization
Overheads
Compliance
Mandatory Norms Adhered to
First Time Right
Fraud Control
Standardization
User Utilization
User Productivity
TAT Reduction
SLA Management
Reduce Exceptions
Technology & Maintenance
Disputes
Courier Cost
Handle 33% More Volume with same users
Reduce up to 55% costs on overheads
Reduce up to
100%
Thank you