unifi 1.5 : simplifying qualification and validation · ©2011 waters corporation 1 june 2012 ....

©2011 Waters Corporation 1

June 2012

UNIFI™ 1.5 : Simplifying Qualification and Validation


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


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


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


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


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


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


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


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


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


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


Unique UNIFI Qualification Center


Review System Status



Select Protocols and Establish FSE Credentials

FSE Credentials



Execute Protocols

Scheduled tests



Review Qualification Results

Out of specification results are flagged using the same analytical tools



Electronically Review, Sign and Approve



Maintain Records and Re-execute When Necessary



Basic Steps to Validate a UNIFI System

Waters Installation Services

Installation and Configuration


Basic Steps to Validate a UNIFI System and the Services We Offer

Waters Compliance Qualification Services

IQ, OQ and PQ




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




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


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


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


Leverage the Vendor Services

Within a framework of responsibility

that makes sense for your company

IQ Vendor

Factory Testing Extended OQ CSV Simple

OQ

unifi 1.5 : simplifying qualification and validation · ©2011 waters corporation 1 june 2012 ....

Documents