©2011 Waters Corporation 1

Overview of NuGenesis 8 SDMS

Data Retention/Legal Hold

©2011 Waters Corporation 2

Agenda

Overview of how NuGenesis 8 SDMS captures and catalogs laboratory-based data into a centralized data repository, as the foundation of the NuGenesis platform.

This workshop will describe the new capabilities of NuGenesis 8 SDMS. Including…

— Record retention

— Legal hold

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NuGenesis 8 Elements

NuGenesis SDMS

NuGenesis ELN

NuGenesis LE Technologies

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Timeline

NuGenesis 8 Introduction PittCon 2012

NuGenesis 8 Release July 2012

NG8 SR1 Release December 2012

NG8 FR1 Release 2014 New capability on the horizon!

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NuGenesis 8 SDMS (inc SR1)

Technology Enhancements — Oracle and Windows OS

Record retention, legal hold — Covering the complete data lifecycle

— Optional EMC² Centera Support

Ease-of-use Improvements — User interface enhancement to improve software navigation

Enhancements for Administrators — More flexible File Capture

— Printer Friendly Audit Trails

Web-based licensing — Based on same technology deployed with Empower 3

And more!

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NuGenesis 8 SDMS Architecture

Technology: —Oracle 11G R2 Database

—Windows 2008 R2 Server (64 bit)

—Windows 7 Professional (64 bit)

—Tomcat 6.0.29

—Java Runtime Environment 1.7

—Internet Explorer 8+9 (compatibility mode)

—XenApp 6 Support

—English and Japanese

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Storage Gateway for OSM

Waters Storage Gateway – paid option (new for NuGenesis 8)

One interface to multiple storage solutions – Tested and supported for SDMS: EMC²

Centera

Can be configured as an OSM Device – For Data Retention enabled projects ONLY

– SDMS Data Retention is supported

Database

OSM

Storage Gateway

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Printer-friendly Audit Trails

New select column and Print button in Audit Trail Viewer

Selected rows will be formatted in a print friendly report

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Print Capture and Extraction Enhancements

Create PDF/A in PDF enabled projects

Apply Extraction Templates to file captured PDFs

Table Extraction with variable column widths

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Extraction Template Enhancement

ALL metadata tags are now available via “Derived Value” – Provides easy access to information that’s not in the report

Select “Tag Value”

Enter Tag Name

Enter Destination

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File Capture to Multiple Projects

Capture files to multiple Server/Project/Template combos from one AA Server

List is processed sequentially – More flexibility

– BUT…

same max. capacity!

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Data Retention and Legal Hold

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Database

Storage vs. Management

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Database

Managed Store

Database ‘light’ at Capture

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Database

Managed Store

Offline Store

Policy based SDMS ‘light’

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Database

Managed Store

Offline Store

Retention Policy based ‘Cleanup’

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Database

Managed Store

Offline Store

Retention Policy based ‘Cleanup’

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Database

Managed Store

Offline Store

Retention Policy based ‘Cleanup’

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Database

Managed Store

Offline Store

The legal ‘Emergency Break’

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Database

Managed Store

Offline Store

The legal ‘Emergency Break’

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Database

Managed Store

Offline Store

The legal ‘Emergency Break’

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Database

Managed Store

Offline Store

‘Break released’

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Database

Managed Store

Offline Store

Lean SDMS

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NuGenesis SDMS

Support for Data Retention & Legal Hold

Industry Segment, Regulator and Type of Record

Typical Retention Period

Pharma: Good Laboratory Practices; records related to a new drug application (NDAs)

Date of submission plus 5 years

Health Care: medical records Life of patient plus “n” years

Drug/device study records Marketing application plus 2-3 years

Government records 20-50 years, or permanent

Copyright records (all organizations) Life of copyright = 95 years or as business needs dictate

Patent records and supporting data Application plus 17 years

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Regulatory Requirements

Examples — GxP demands archival of records for extended time

Industry Segment, Regulator and Type of Record

Typical Retention Period

Pharma: Good Laboratory Practices; records related to a new drug application (NDAs)

Date of submission plus 5 years

Health Care: medical records Life of patient plus “n” years

Drug/device study records Marketing application plus 2-3 years

Government records 20-50 years, or permanent

Copyright records (all organizations) Life of copyright = 95 years or as business needs dictate

Patent records and supporting data Application plus 17 years

Q What are your retention requirements?

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SDMS Data Retention

Data Retention can be enabled on a project — Cannot be turned off

— No manual deletion possible through VISION

— Governed by Retention Policies

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Data Retention Policies

Defined by — Fixed future date

2015 2025 2035 2045

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Data Retention Policies

2015 2025 2035 2045

Defined by — Fixed future date

— Days/months/years after date-based tag field

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Data Retention Policies

Defined by — Fixed future date

— Days/months/years after date-based tag field

— Event (future event + x dd/mm/yyyy)

• Events are triggered manually

Manual or automatic deletion

Manual deletion with or without reauthentication

2015 2025 2035 2045

?

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Data Retention Policies

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SDMS Data Retention

Manual or automatic deletion after expiration — Deletion of metadata, binary data, and record audit trail

— From DB, Managed Storage, and OSM

— The act of deletion is logged in the system audit trail

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Manual Deletion

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Legal Hold

Will prevent:

— Changes to the record

— Changes to the metadata

— Deletion

— Data Retention Management

Allowed:

— OSM

— Data Management

Privilege controlled

Multiple legal holds possible

Across Projects

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Questions?

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