UNIFI 1.5 : Simplifying Qualification and Validation June 2012

UNIFI 1.5 : Simplifying Qualification and Validation June 2012 2011 Waters Corporation 1

Waters Regulated Bioanalysis System Solution Sample Preparation Solutions Best in class ACQUITY UPLC I-Class The fastest and most resolving LC without compromise in robustness ACQUITY UPLC Columns Different choices for best performance TQ-S Most sensitive MS UNIFI Compliance-ready Interactive workflow-driven data platform Service Installation, maintenance & training Compliance services 2011 Waters Corporation 2

Why is Change So Painful? Increasing regulatory demands Evolving analytical demands 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 2011 Waters Corporation 3

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 [*GAMP 5 ] 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 4

Reducing Software Validation Barrier Present Desire Future GAMP 5 for COTS Leverage Vendor testing Test Summary document Vendor Quality systems Supplier Assessment Built in Tools for Verification Development of common Validation Scripts Built in tools to automate running and documenting scripts SOFTWARE Barriers VALIDATION? Built in Tools for Qualification Qualification Center to manage IQ and OQ of Software and Instruments Portal installation on Clients 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 5

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 6

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 7

Services Customers ask Vendors IQ Simple OQ Computer System Validation Testing IQ Simple OQ Vendor Factory Testing PQ or UAT s CSV IQ Extended OQ CSV IQ Comprehensive Validation Service PQ and full Docs ( VP and VR) 2011 Waters Corporation 8

Scalable, open architecture allows for future growth and sharing of information Enables Managed Information Sharing & Simplifies Compliance Efforts Client PC Presentation Layer Client PC Presentation Layer Client PC Presentation Layer Capture Agent Laboratory Network Appliance Instrument Control << LABORATORY NETWORK >> Secure Data Center Business Layer Database Layer Server Instrument Control Laboratory Network Appliance 2011 Waters Corporation 10

UNIFI Qualification Workflow Review System Status Select Protocols Execute Protocols Review Qualification Results Sign and Release Maintain Records and Re-execute Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 2011 Waters Corporation 12

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 13

Unique UNIFI Qualification Center 2011 Waters Corporation 14

Review System Status Step 1 2011 Waters Corporation Step 2 Step 3 Step 4 Step 5 Step 6 15

Select Protocols and Establish FSE Credentials FSE Credentials Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 2011 Waters Corporation 16

Execute Protocols Scheduled tests Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 2011 Waters Corporation 17

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 18

Electronically Review, Sign and Approve Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 2011 Waters Corporation 19

Maintain Records and Re-execute When Necessary Step 1 2011 Waters Corporation Step 2 Step 3 Step 4 Step 5 Step 6 20

Basic Steps to Validate a UNIFI System Waters Installation Services Installation and Configuration 2011 Waters Corporation 21

Basic Steps to Validate a UNIFI System and the Services We Offer Waters Installation Services Installation and Configuration Waters Compliance Qualification Services IQ, OQ and PQ 2011 Waters Corporation 22

Basic Steps to Validate a UNIFI System and the Services We Offer Waters Installation Services Installation and Configuration Waters Compliance Qualification Services IQ, OQ and PQ Waters Compliance Services Professional Services Validation Suite Tools and Templates 2011 Waters Corporation 23

UNIFI Software Validation Suite Templates Available Templates Software Validation Suite Validation Plan User Requirements Specification Design & Configuration Spec n Risk Assessment Traceability Matrix Test Plan Standard Operating Procedures Validation Summary Report 2011 Waters Corporation 24

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 Computer Systems Verification Testing Time (Days) 16 14 12 10 8 6 4 2 0 Development Review Execution Manual 15 10 5 Automated 5 5 2 2011 Waters Corporation 25

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 26

Leverage the Vendor Services Vendor Factory Testing IQ Simple OQ Extended OQ CSV Within a framework of responsibility that makes sense for your company 2011 Waters Corporation 27