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©2011 Waters Corporation 1
June 2012
UNIFI™ 1.5 : Simplifying Qualification and Validation
©2011 Waters Corporation 2
Waters Regulated Bioanalysis System Solution
• Best in class
Sample Preparation Solutions
• The fastest and most resolving LC without compromise in robustness
ACQUITY UPLC® I-Class
• Different choices for best performance
ACQUITY UPLC Columns
• Most sensitive MS
® TQ-S
• Compliance-ready • Interactive workflow-driven data platform
UNIFI
• Installation, maintenance & training • Compliance services
Service
©2011 Waters Corporation 3
Why is Change So Painful?
Documented evidence — Systems and software they use is “ fit for
purpose”
— Costly: time and money
How can Waters help the customer? — Systems developed under a documented
quality process (SDLC)
— Provide the customer with installation and compliance services
Increasing regulatory demands
Evolving analytical demands
©2011 Waters Corporation 4
Regulatory Terms
Analytical Instrument Qualification o Includes computers and infrastructure
o Part of the validation process that tests performance at a specific point in time (deployment or after a change)
o Documented evidence that an instrument performs suitably for its intended purpose and that it is properly maintained and calibrated [USP 1058]
Computerized System Validation o The documented process that manages the total product life time
from definition, development through use and maintenance. Validated state is preserved by good change control
o Achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by …throughout the life of the system [*GAMP5]
o Supported by qualification testing (IQ/OQ/PQ)
Instruments, systems and computers are qualified.
Software applications, processes, and methods are validated. * Good Automated Manufacturing Practice revision 5
©2011 Waters Corporation 5
Reducing Software Validation Barrier
Present Future Desire
Barrie
rs S
OFTW
AR
E
VA
LID
ATIO
N
GAMP 5 for COTS Leverage Vendor testing Test Summary document Vendor Quality systems
Supplier Assessment
Built in Tools for Qualification
Qualification Center to manage IQ and OQ of
Software and Instruments Portal installation on
Clients Built in Tools for Verification
Development of common Validation Scripts
Built in tools to automate running and documenting
scripts
Validation Consulting Integrate common scripts into a complete validation
package customised to Customer protocols
?
Waters Quality System and Professional Services can significantly reduce the Validation effort
©2011 Waters Corporation 6
GAMP 5 – Scaling Validation effort according to RISK
Computerized systems are mostly networked COTS
Avoid duplication of activities (whole system)
Leverage supplier activities to maximum
Scale life cycle activities to risk, complexity, and novelty
Simplified development model
©2011 Waters Corporation 7
Waters Quality Software Development
Quality Mission Statements and policies available online
Regulatory Position FAQ’s available online
Software Testing protocols available on request
Supplier Assessment / Postal Audit answers supplied
Other Quality documents available during On site audits
According to GAMP 5* guidelines for Validation these can be used to support a Risk Assessment to reduce the amount of testing a Laboratory needs to do
Also recommends laboratories to “ leverage vendor services” for validation
©2011 Waters Corporation 8
Services Customers ask Vendors
IQ
IQ
Simple OQ
Extended OQ CSV
Computer System Validation Testing
IQ Comprehensive Validation Service PQ and full Docs ( VP and VR)
IQ Simple OQ
PQ or UAT’s CSV Vendor Factory Testing
©2011 Waters Corporation 10
Scalable, open architecture allows for future growth and sharing of information
<< LABORATORY NETWORK >>
Laboratory Network Appliance
Instrument Control
Server
Presentation Layer
Presentation Layer
Client PC Client PC
Business Layer Database Layer
Instrument Control
Laboratory Network Appliance
Presentation Layer Capture Agent
Client PC
Secure Data Center
Enables Managed Information Sharing & Simplifies Compliance Efforts
©2011 Waters Corporation 12
UNIFI Qualification Workflow
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
Review System Status
Select Protocols
Execute Protocols
Review Qualification Results
Sign and Release
Maintain Records and Re-execute
©2011 Waters Corporation 13
UNIFI Qualification Centre
Perform instrument and software qualifications automatically — Modules
— Instrument as Systems
— PC’s
Record all Maintenance and Qualification Events
Store all qualification reports/results electronically
Store Firmware versions as well as ID of modules
©2011 Waters Corporation 14
Unique UNIFI Qualification Center
©2011 Waters Corporation 15
Review System Status
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 16
Select Protocols and Establish FSE Credentials
FSE Credentials
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 17
Execute Protocols
Scheduled tests
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 18
Review Qualification Results
Out of specification results are flagged using the same analytical tools
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 19
Electronically Review, Sign and Approve
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 20
Maintain Records and Re-execute When Necessary
Step 1 Step 2 Step 3 Step 4 Step 5 Step 6
©2011 Waters Corporation 21
Basic Steps to Validate a UNIFI System
Waters Installation Services
Installation and Configuration
©2011 Waters Corporation 22
Basic Steps to Validate a UNIFI System and the Services We Offer
Waters Compliance Qualification Services
IQ, OQ and PQ
Waters Installation Services
Installation and Configuration
©2011 Waters Corporation 23
Basic Steps to Validate a UNIFI System and the Services We Offer
Waters Compliance Qualification Services
IQ, OQ and PQ
Waters Compliance Services Professional Services Validation Suite Tools and Templates
Waters Installation Services
Installation and Configuration
©2011 Waters Corporation 24
UNIFI Software Validation Suite Templates
Validation Plan User Requirements Specification Design & Configuration Spec’n Risk Assessment Traceability Matrix Test Plan Standard Operating Procedures Validation Summary Report
Available Templates
Software Validation Suite
©2011 Waters Corporation 25
Proven Experience in Validation Support
Certified Waters Product and Validation Specialists. — 10 Years supporting Validation of SDMS
— 5 Years supporting validation of Empower
— Now offering the same services for UNIFI
Typical time saving by including expert services from Waters
Development Review Execution
Manual 15 10 5
Automated 5 5 2
0
2
4
6
8
10
12
14
16
Tim
e (D
ays)
Computer Systems Verification Testing
©2011 Waters Corporation 26
How Does UNIFI Help the Customer with Compliance?
Industry leading security, compliance configurations — Built in change control tools for the regulated laboratory — Audit Trails and Notification generated automatically
— Electronic signature approval and work flow
— User interface adjusts to roles and capabilities of users
Architecture designed to minimize Qualification efforts — Minimal installation on client PC’s using a Client Portal
— Instrument drivers can be added and updated individually thereby minimizing the change control
— Waters recommends re-qualification activities when changes occur i.e. driver updates and service packs
Built in Qualification center facilitates fast implementation and Compliance qualification services
Comprehensive Compliance Services offerings allow for rapid deployment to production initially and on update
©2011 Waters Corporation 27
Leverage the Vendor Services
Within a framework of responsibility
that makes sense for your company
IQ Vendor
Factory Testing Extended OQ CSV Simple
OQ