Navigating the Complexity of Life Science Compliance: A QAD Regulatory Primer Pete Schaubach October...
-
date post
19-Dec-2015 -
Category
Documents
-
view
216 -
download
1
Transcript of Navigating the Complexity of Life Science Compliance: A QAD Regulatory Primer Pete Schaubach October...
Navigating the Complexity of Life Science Compliance: A QAD Regulatory Primer
Pete SchaubachOctober 10, 2011
2
• Pete Schaubach• Business Development Director, Life
Sciences • Previously…
- CIO, AGA Medical - CIO, ev3- Business Systems Integration Director,
Medtronic - Information Services Director, SCIMED/BSC- …
Introduction
3
• Integrating regulatory compliance into your systems and processes while maintaining business flexibility is a challenge for every Life Sciences company.
• What can we do about this?
Subject
4
• Overview of business challenges• My experiences at ev3• How QAD can help
• Interaction welcome!
Agenda
5
• External- Margin pressures from competitors and
customers- Increased regulatory pressure on all aspects of
product lifecycle
• Internal- Cost management/efficiency- Information Technology management
Business Challenges
• Key Issues- Increased competition- Healthcare reform- Customer consolidations- Group Purchasing Organizations- Revenue exposure in chargebacks &
fees- Higher raw material & supply chain cost
Margin Pressures
External challenges
6
7
• cGMP- current Good Manufacturing Practice
• Track & Trace• Electronic records management
- European Commission Annex 11- US-FDA 21 CFR Part 11
Increased regulatory pressure
External challenges
• Key Issues- Regulations governing drug or device safety
- Monitoring of adverse events
- Managing global supply chain and supplier quality
Greater Focus on Quality and Safety
External challenges
8
9
• Regulatory AgenciescGMP
External challenges
Poland Japan
China
USA Canada Mexico
Europe
Australia
10
• Organization and personnel• Buildings and facilities • Equipment acquisition and maintenance• Control of components & products• Production and process controls• Packaging & Labeling• Identification and traceability• Holding and distribution• Records & Reports• Returns and Complaints
cGMP
External challenges
11
• US FDA Regulations- Finished Pharmaceuticals (human and animal
products): 21 CFR 210 and 21 CFR 211- Biological products: 21 CFR 600- Blood and blood-derived products: 21 CFR 606- Medical devices (“Quality System Regulation”):
21 CFR 820- Dietary supplements (published by FDA in June
2007): 21 CFR 111
cGMP
External challenges
FDA Quality System Requirements
External challenges
12
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
• Annex 11 This annex applies to all forms of
computerised systems used as part of a GMP regulated
activities. A computerised system is a set of software and hardware components which
together fulfill certain functionalities. The application should be validated; IT
infrastructure should be qualified.
– Commission EuropeenneDeadline June 30, 2011
Electronic Records Management
External challenges
• 21 CFR Part 11 All production and/or quality system software, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use
– United States Food & Drug Administration
Electronic Records Management
External challenges
15
• Contents- Electronic system as replacement of Paper- Security- Data Transfer- Audit Trails- Electronic Signatures- Computer System Validation- Training- Supporting Procedural Infrastructure
21 CFR Part 11
External challenges
• Key Issues- Increased product and compliance costs- Product commercialization
• Global expansion• Operating in emerging markets• Meeting revenue & growth targets
- Continued focus on Lean principles- Increased leverage of shared services
Cost management/efficiency
Internal challenges
16
• Key Issues- Reliability- Scalability- Cost predictability- Flexibility- Upgrade barriers
• Customizations• Resources• Time
Information Technology Management
Internal challenges
17
19
• Build a $1B global medical device company from scratch- Focus on three markets
• Cardiovascular (heart)• Neurovascular (brain)• Peripheral (legs)
- Acquire and integrate quickly- Establish direct operations in global markets- Leverage centralized management and
services
ev3
My story
20
• We chose QAD for core reasons- Reputation based on BSC and Medtronic
experiences- Support for regulatory requirements- Solid supply chain functionality- Ease of implementation
Selection criteria
ev3
21
• One source of the truth- Single instance- Standard processes- Strong data governance- Easy access to information
• Strong alignment between business and IT- Core process focus- Ability to execute- Flexibility
Key strategies
ev3
22
• Leveraged strong QAD capabilities- Compliance module controls- Forward and backward traceability- EAM for CFR Part 820 and ISO 13485
• Part 11/SOX change control requirements- Simple risk-based assessment with every
request- Compliance requirements in every project plan
• Standard SDLC/change management- Standard process continuous improvement- Reduced risk/fear of change
Compliance
ev3 strategies
23
• Operate at the pace of business• Steady delivery of high-value
improvements• Project duration: 3 days, 3 weeks, 3
months- 3 Days: Single function affected
• Report modification
- 3 Weeks: Single organization• Kaizen event opportunity, process change
- 3 Months: Multi-organization• New process, acquisition integration
Flexibility
ev3 strategies
24
• Europe implemented in 2 months- EU distribution center, 7 sales offices
• US implemented in 2 months- US distribution, sales & manufacturing
• Subsequent rollouts- Japan distribution and sales office- Multiple manufacturing sites in US and EU
• $40MM to >$440MM in six years• From 40 to 800 users today
Results
ev3
25
• Leverage QAD compliance capabilities• Take advantage of on-demand• Use the Validation toolkit• Leverage QAD Reporting Framework and
BI
What if I had to do it again?
26
cGMP Compliance
What if…
Organization and personnel Process Maps
Buildings and facilities EAM
Equipment Acquisition and Maintenance EAM
Control of component & products QAD EA
Production and process controls QAD EA Compliance
PCC
Packaging and labeling QAD EA
Holding and distribution QAD EA WMS
Records and reports QAD EA
Returns and complaints SSM
E-Controls
WMS
27
• Avoid multiple data center expenditures• Avoid redundant support personnel• Leverage resources and expertise for
qualified environments and upgrades• Provide remote site application support
- Europe- Asia
• Leverage Hybrid environment for emerging markets
On Demand
What if…
28
Global CoverageOn Demand Services
United KingdomBrierley Hill
BelgiumAntwerp
ItalyMilan
The NetherlandsSchiphol Rijk
JapanTokyo
ThailandBangkok
ChinaShanghai
IndiaMumbai
South AfricaDurban
SpainBarcelona
BrazilSao Paulo
MexicoMexico City
United StatesCalifornia
AustraliaSydney
PolandWroclaw
United StatesIllinois
United States
New JerseyUnited StatesGeorgia
United StatesUtah
QAD Support and Data Centers = Local Presence, Global Reach
29
On Premise vs. On Demand
On PremiseYour Data Center
Typ. ~95% AvailabilityYour Support HoursSome Languages
Your Upgrade CycleBackup?
Disaster Recovery?Dedicated Personnel?
On DemandSAS 70 Secure Data Center
>99.5% Availability24 x 7 Multi-Language Support
Always Current VersionConstant Database AdminUsage Analysis & Reporting
Failover & Recovery SiteOff Site Backup
Guaranteed Capacity300+ Certified Personnel
On Demand
Full Strength ERP
.NET UI
24 x 7 SupportNew Version Annually
Personalization
Revenue Expense
Scalable
On Premise
Full Strength ERP
.NET UI
Business Hours SupportNew Version?
Customization
Capital Expense
Scalability Challenge
What if…
Implement
•Rapid Implementation•Best Practices•Fixed Fee
Transition
•Environment Migration•Transition Management•Fixed Fee
Transformation
•Upgrade•Application Conversion•Best Practice
Deliver ManageEasy
On-Boarding
Service Components
What if…
32
• Proven, best-practice methodology• Built-in continuous improvement• Pre-defined reports and validation scripts
Validation toolkit
What if…
Validation Master Plan
Inst
alla
tion
Qu
alif
ica
tion
•Hardware
Installation
•Software
Installation
•Installation
Qualification Report
QAD Purchase
Delivery
Installation
User RequirementsSpecification
GXP Requirements
Des
ign
Qu
alif
icat
ion
SystemAcceptance
Data InstallationQualification
Execute PerformanceQualification
Write PerformanceQualification Plan
Execute OperationalProtocols
OperationalQualification Plan
ConfigurationFit to Business
Ope
ratio
na
l Qu
alif
ica
tion
Per
form
an
ce
Qua
lific
atio
nIn
sta
llatio
n Q
ualif
ica
tion
•Baseline Configuration
Document
•Define Functional Requirements
•Traceability Matrix
•Risk Assessment
•Operational Qualification Protocols
•Performance Qualification and Stress Test
•Operational Qualification ProtocolSummary Report•Disaster Recovery Protocols
•Validation Report
= Deliverables
•Performance Qualification Protocol Summary Report
•Data Migration•Data Installation QualificationProtocol Summary Report
Strategic Validation MethodologyWhat if…
• Installation Qualification Protocol (IQ)• Operational Qualification Protocol (OQ)
- Distribution - Master Files- Manufacturing
• Performance Qualification Protocol (PQ)• Functional Requirements• Risk Analysis• Traceability Matrix
Validation Toolkit includes:What if…
• Security• Sales Orders• Routings• Compliance • Quality Management • Inventory Control • Distributed Orders • Item-Site Master
Records• SSM
• Purchasing • Physical Inventory • Formulas • Product Change
Control• Processes • Work Order• Shop Floor Control• Product Structures
Validation Scripts
What if…
36
• Leverage QAD Reporting Framework and BI- Minimize the use of forms packages- Easily create alerts and automatic delivery of
reports- Avoid long development time of ETL processes
and custom BI data marts
Reporting
What if…
37
• Upgrade• Convert to a new version• Unwind customizations
- Convert to new standard functionality- Mitigate complex customizations with ICT
• Convert to On Demand• Validation
Problems Solutions
How can we help?
• Regulatory uncertainty and inconsistency- Serialization (EMEA, China, Turkey, US)
• Unit level serialization Rx • Track & Trace • International, Federal, and State rules differ
• California ePedigree (2015)• Federal Buyer & Matherson • FDA Serialization (2011)• EU
- EFPIA (European Pharmaceutical Industry Association) – Plans for Pilot Mass Serialization project
- Italy – Bolini, 2005- Turkey – Jan 1, 2009- Greece – National Registration Number + Sequential Number- Spain – Start to Define Serialization
• China (2009)
Serialization LegislationBusiness Requirements
41
E-Pedigree Planned Schedule
Business Requirements
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 EU
Current Federal Law (1988 PDMA)
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Buyer-Matheson Legislation (HR 5839)
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 California SB1307
Pedigree (non-serialized) only on non-ADR transactions (<5%) (Implementing regulations enjoined by U.S. District court)
Pedigrees (non-serialized) on 100% of products nation wide
Manufacturer Serialized Non High Risk
Manufacturer Serialized High Risk
Dist. T&T High Risk
T&T Non-High Risk
RPH. T&T High Risk
T&T Non-High Risk
Federal PDMA Standard (Pedigree (on serialized) only on non-ADR transactions (<5%))
Manufacturer serialize 50% Rx & Pedigree
Manufacturer serialize 100% Rx products
Distributor T&T
Pharmacies T&T
Turkey
EU