Continued Process Verification (CPV)

Automation

Perkin Elmer 2016

Data Analytics & R&D Informatics User Conference

Willy RIBUS Nov-3th 2016

2 Agenda

1. Lifecycle Process Validation Model

2. Continued Process Verification Program

i. Multi generation Plan

ii. Current status

iii. CPV Automation Phase 1

3. CPV Automation Phase 1 Demo session

4. Next steps

5. Q & A

3 Lifecycle Process Validation Model

4

1. Lifecycle Process Validation Model

2. Continued Process Verification Program

i. Multi generation Plan

ii. Current status

iii. CPV Automation Phase 1

3. CPV Automation Phase 1 Demo session

4. Next steps

5. Q & A

Agenda

5 Continued Process Verification Program

6

LIMS Data

Legend:

Manual process

Automated process

Analytical data

Process data

Reporting

Data

Collection

Data

analysis

Data

Collection

Ref data

collection

Reference Data

Paper batch

records

Specs,

Control limits …

CPV Automation Phase 1 - Starting point

Reporting

Data

Collection

Data

analysis

Phase1 - Tibco-Spotfire User interface

LIMS Data

ENTERPRISE DATA WAREHOUSE

Statistical Analysis

Template SM

Template LM

Template FF

Analytical

data

Analytical &

Process

data

Data

Collection

Phase 1 - Manual Data Entry Module

Process

data Paper batch

records

Phase 1- Reference Data module

Ref data

Maintenance

Oracle DB

Reference data

CPV Automation Phase 1 - Modules 7

5. Data

analysis &

Reporting

4. Data Load

3. Product, Period, Attribute

& Parameter selection

1. Workflow Selection

2. Open existing CPV analysis

Start

NEW RESUME RENEW VIEW

Product selection

Attribute / Parameter selection

Period selection

Identify Batch qty per

selected parameter

• Generate temporary CPV report • Review temporary CPV Report • Generate final CPV report

Select & Open existing

CPV analysis

Batch quantity

OK?

Period Extension

CLONE

Load data for each selected parameter

Data analysis

Yes

No

Visual inspection

Distribution plot

Yes

Highly Non Normal Distr.?

Consult statistician

No

• Investigate control charts • Exclude data points • Insert comments on alerts

Reporting

Select & Open existing

CPV analysis

Reference data Management

• Link to module to maintain reference data

CPV Limits & Ppk indexes

• Calc. current CPV limits and Ppk • Comparison with fixed CPV limits

/ Ppk indexes

Executive Summary

• Insert references to investigations • Define if actions required

Data Export • Data export capability for non-

CPV applications

CPV Automation Phase 1 - Process Flow 8

Login

• Single sign-on

• Define users’ roles

Data

access

• EDW (Teradata)

• Ora DB

Selection process

• Workflow selection

• Parameters selection

• Period selection

Automated

analysis

• Statistical analysis

• Automatic generation of visualizations, feeding Persistence Layer

User

Interface

• Interactivity

• HTML custom panels

• Showing / Hiding Visualizations

Persistence

Layer

• Store metadata

• Store visualizations

Report

Generation

• Use data from Persistence Layer

• Use Report Templates

CPV Automation Phase 1 – Components

Re-use

analysis

• Re-use of analysis supported by different work flows

• Retrieval meta data from persistence layer

9

1. Lifecycle Process Validation Model

2. Continued Process Verification Program

i. Multi generation Plan

ii. Current status

iii. CPV Automation Phase 1

3. CPV Automation Phase 1 Demo session

4. Next steps

5. Q & A

Agenda 10

CPV Automation Phase 1 – Demo session

5. Data

analysis &

Reporting

4. Data Load

3. Product, Period, Attribute

& Parameter selection

1. Workflow Selection

2. Open existing CPV analysis

Start

NEW RESUME RENEW VIEW

Product selection

Attribute / Parameter selection

Period selection

Identify Batch qty per

selected parameter

• Generate temporary CPV report • Review temporary CPV Report • Generate final CPV report

Select & Open existing

CPV analysis

Batch quantity

OK?

Period Extension

CLONE

Load data for each selected parameter

Data analysis

Yes

No

Visual inspection

Distribution plot

Yes

Highly Non Normal Distr.?

Consult statistician

No

• Investigate control charts • Exclude data points • Insert comments on alerts

Reporting

Select & Open existing

CPV analysis

Reference data Management

• Link to module to maintain reference data

CPV Limits & Ppk indexes

• Calc. current CPV limits and Ppk • Comparison with fixed CPV limits

/ Ppk indexes

Executive Summary

• Insert references to investigations • Define if actions required

Data Export • Data export capability for non-

CPV applications

11

1. Lifecycle Process Validation Model

2. Continued Process Verification Program

i. Multi generation Plan

ii. Current status

iii. CPV Automation Phase 1

3. CPV Automation Phase 1 Demo session

4. Next steps

5. Q & A

Agenda 12

CPV automation - Next steps

1. CPV Automation Phase 2

Auto retrieval of Process data for integration within CPV analysis

2. CPV Automation Fine tune cycle

Improve and Extend current CPV automation functionality

13

14

Data

analysis

Phase1 - Tibco-Spotfire User interface

LIMS Data

ENTERPRISE DATA WAREHOUSE

Statistical Analysis

Template SM

Template LM

Template FF

Analytical

data

Analytical &

Process

data

Data

Collection

Phase 1 - Manual Data Entry Module

Process

data Paper batch

records

Phase 1- Reference Data module

Ref data

Maintenance

Oracle DB

Reference data

CPV Automation Phase 2

Phase 2 - PI Integrator

Global PI AF-EF

PI Historian

Automation

Level 1&2

PI integrator for business analytics

Interface

15

Improve and Extend current CPV automation functionality based on

• User feedback during received during 1st usage of application

• Add additional functionality not covered during phase 1 (Park lot)

• Anticipate on new business requirements as specified in ongoing update of

global SOP / WI

CPV Automation Fine tune cycle

16

Thank you