Services for Regulated Bioanalysis System Solution June 2012

Transcription

1 Services for Regulated Bioanalysis System Solution June Waters Corporation 1

2 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 Compliant, Interactive workflow-driven data platform Service Installation, maintenance & training Compliance services 2011 Waters Corporation 2

3 Waters Service and Support 2011 Waters Corporation 3

4 Remote Monitoring and Diagnostics Maximize System Uptime and Increase Laboratory Productivity Secure, web-based system monitoring Instant alert notification A direct link to Waters technical experts 2011 Waters Corporation 4

5 Waters Service and Support Project Management System Design & Configuration Installation Services Training Instrument Qualification Software Validation Repair & Maintenance Waters Quality parts Method validation Method transfer 2011 Waters Corporation 5

6 Scalable Compliance Services: [Routine Qualification Services] Instrument IQ/OQ/PQ Software IQ/OQ Software IQ Processing OQ Reporting OQ Instrument Control Verification 1 Data Acquisition Verification 1 Instrument IQ Flow rate linearity Flow rate accuracy Gradient accuracy Gradient precision Detector linearity Carryover Noise Drift Wavelength linearity Wavelength accuracy Injector linearity Injector precision Injector accuracy MS linearity MS mass resolution MS gain MS sensitivity MS noise 1 If done with Instrument OQ/PQ, these functions are verified. Note: Installation service fees not included 2011 Waters Corporation 6

7 Scalable Compliance Services: [Extended Software Qualification] Instrument IQ/OQ/PQ* Software IQ/OQ System Design & Configuration Configuration Verification Extended Software OQ/PQ Software IQ Admin & Security OQ/PQ Processing OQ/PQ erecords OQ/PQ Reporting OQ/PQ esignatures OQ/PQ Inst Control Vrf n 1 Audit Trails OQ/PQ Data Acq n Vrf n 1 Fault Tolerance OQ/PQ 2 1. If done with Instrument OQ/PQ, these functions are verified. RegBio Extended Software Qualification Services: Extended Software Qualification Compliance services for Waters' Regulated BioAnalysis System. Includes installation qualification and configuration verification (documented in a system Design and Configuration Specification), as well as software operational qualification testing. Service terms and conditions are per Statement of Work. *Routine instrument Qualification services are recommended but not included. Includes Routine Software Qualification for 1 computer. 2. Applicable to UNIFI-based systems only Note: Installation service fees not included 2011 Waters Corporation 7

8 Scalable Compliance Services: [Core Validation Services] Instrument IQ/OQ/PQ* Software IQ/OQ System Design & Configuration Configuration Verification Extended Software OQ/PQ Software IQ Processing OQ/PQ Reporting OQ/PQ Inst Control Vrf n 1 Data Acq n Vrf n 1 Template User Requirements Spec Traceability Matrix / Test Plan 1. If done with Instrument OQ/PQ, these functions are verified. 2. Applicable to UNIFI-based systems only Note: Installation service fees not included Admin & Security OQ/PQ erecords OQ/PQ esignatures OQ/PQ Audit Trails OQ/PQ Fault Tolerance OQ/PQ 2 RegBio Core CSV Compliance Services: Core Computer Systems Validation Compliance services for Waters' Regulated BioAnalysis System. Includes installation qualification and configuration verification, operational qualification testing as well as template core CSV documents (User Requirements Specification, Design/Config Specification, Test Plan/ Traceability Matrix). Service terms and conditions are per Statement of Work. *Routine instrument Qualification services are recommended but not included. Includes Routine Software Qualification for 1 computer Waters Corporation 8

9 Scalable Compliance Services: [Extended Validation Services] Instrument IQ/OQ/PQ* Software IQ/OQ System Design & Configuration Configuration Verification Extended Software OQ/PQ Template URS Traceability Matrix / Test Plan Validation Planning Requirements Development Risk Assessment SOP Templates Validation Reporting RegBio Extended CSV Services: Extended Computer Systems Validation Compliance services for Waters' Regulated BioAnalysis System. Includes installation qualification and configuration verification, operational qualification testing as well as template CSV documents (Validation Plan, User Requirements Specification, Risk Assessment, Design/Configuration Specification, Test Plan/ Traceability Matrix, Validation Summary Report, SOPs), and validation consulting days to facilitate validation activities and the preparation of validation deliverables. Service terms and conditions are per Statement of Work. Service based on a standardized SOW. Development of a tailored SOW is recommended. *Routine instrument Qualification services are recommended but not included. Includes Routine Software Qualification for 1 computer Waters Corporation 9

10 RegBio Validation Suite Sales Tools and 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 10

11 Reducing Software Validation Barrier Present Desire Future GAMP 5 for COTS Leverage Vendor testing Test Summary document Built Vendor in Quality Tools for systems Verification Supplier Audit Development of common Validation Scripts Built in tools to automate running and documenting scripts Barriers SOFTWARE VALIDATION Built in Tools for Qualification Qualification Centre to manage IQ and OQ of Software and Instrument Validation Portal installation Consulting Integrate Clients common scripts into a complete validation package customised to Customer protocols 2011 Waters Corporation 11

12 Leveraging Vendor Services IQ Simple OQ PQ or UAT s IQ Simple OQ Vendor Factory PQ or Testing UAT s PQ or UAT s IQ Extended OQ PQ or UAT s IQ Comprehensive Validation Services 2011 Waters Corporation 12