ANDRE SCHALCH / MISSY BURK

08/30/17

UPGRADING SAMPLEMANAGERTM

LIMS: THE CRITICAL FACTORS

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THE PRESENTERS

Andre Schalch, Managing Services Engineer, Astrix Technology GroupAndre Schalch is a Managing Services Engineer for the Astrix Professional Services Group where he leads a team focused on SampleManager LIMS implementations. He has over 15 years of hands-on experience with implementations of LIMS, CDS, SDMS and ELN systems for different types of industries (environmental, pharmaceutical, petrochemical, mining, etc..), mostly focused on products from ThermoFisher Scientific (SampleManager and Nautilus LIMS).

Missy Burk, Informatics Engineer, Astrix Technology GroupMissy Burk is an informatics engineer for the Astrix Professional Services Group, and she has been working with SampleManager LIMS for the last 3 years – 2 years customizing and configuring SampleManager 10, and the last year working to implement a global instance of SampleManager 11. Ms. Burke joined Astrix as an analytical chemist with 15+ years of lab system experience across multiple industries including medical reference, environmental monitoring and pharmaceutical manufacturing. Ms. Burk has installed, validated andmaintained instruments and software including ChemStation, Empower, Winlab and LabX applications, to name a few.

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AGENDA

Upgrade of SM – Common Factors Types of SM upgrades SM Evolution: Versions and Key Features Supported Versions Instrument Integration on SM SM Modules Building a Business Case for your SampleManager upgrade Q and A session

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POLLING QUESTION #1

SM VERSION

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ABOUT THE UPGRADE AND MIGRATION

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UPGRADING SM – COMMON FACTORS

Limited Resources

Functional Improvements (Bug

Fixes / New Functionality)

New Business and Regulatory

Requirements

Hardware / Software Supported and new Architecture desired

Current SM Version and Implementation

Age

Desired SM Version and Maturity

Level of Customization and

Impact to other Applications (Interfaces)

Regulated, GxP, Validated

Environment?

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TYPES OF SAMPLEMANAGER UPGRADES

BASIC (~5 MD)*

• Straight upgrade of the SM10+ system to bring the system to the new agreed version

• Little to none customization

• No hardware / architecture changes (same servers used)

• No utilization of new functionality or new modules

MODERATE (~15 MD)*

• Upgrade of SM and Modules (usually IM) used to the new agreed version

• “Some” customization on the system

• SM9- version upgrades

• New hardware / architecture (Cloud/AWS)

• Minimal Configuration to enable use of new functionality / consulting on the new functionality

COMPLEX (TBD –CASE BY CASE)

• Implementation of new functionality, changes to labs and business processes

• Upgrade of SM to the new agreed version and installation of new modules (SQC, Stability, SMIDI)

• New hardware / architecture (Cloud / AWS)

• Oracle to SQL Server vice-versa

• Customization assessment and replacement with OOTB SM11+/12 functionality

(*) Note: Estimates above are for non-validated environments

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SAMPLEMANAGER EVOLUTION: VERSIONS AND KEY FEATURES

9

SM 2004 RX

SM2004 R1 and R2 Very Robust SM version (VGL) Rudimentary Explorer Folders Initial SM Web interface Timezone Support Multiple Modules Available SQC Stability SMIDI LIMS Reporter (Infomaker) WM PIMS

2004 2017

SM3.x, SM4.x, SM200X

SM2004 R1/R2

Server Windows 2000 Server Windows 2003 Server

Database Oracle 9i

10

SM 9.X

SM9.0 .NET technology Framework Explorer Folder with easy to filter datasets

Enhanced MLP Checking FlexNet Licensing

SM9.1 SQL Server support SM9.2 .Net Framework 2.0 support Explorer Hierarchy Performance and Maintenance fixes

SM9.2.1 64-bit support

2004 2017

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

Server Windows 2003 Server

Database Oracle 9i, 10g SQL Server 2005

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SM 10.0

SM10.0 Report Designer / Label Designer Forms Designer (.Net Forms/Property Sheets) ISO17025 support Instrument calibration, servicing, Training Records Linked to Analysis and Result Entry

Substance, Hazard, Stock Management Scheduler Location Types Extensive Explorer Enhancements Background Services Analysis /Result Entry / Inspection Enhancements Change User / Reconnect menu

2004 2017

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

Server Windows 2008 Server

Database Oracle 10g, 11.1, 11.2 SQL Server 2008

2010 / 2012

SM10.0, SM10.1, SM10.2

SM10.3 SM10.4 SM10.5

2013 2014 2015

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SM 10.X

SM10.1 Result Entry Improvements (Result Types and Lock

Information) GHS Hazard Support Forms Designer / API Improvements

SM10.2 Maintenance Release / Startup Procedure PI Trust for PIMS Interface

SM10.3 Improved Esigs checksum SM10.4 , SM10.5 WCF WDT Improvements Forms Designer API Improvements ADO Connection for SQL Server

2004 2017

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

Server Windows 2008 Server

Database Oracle 10g, 11.1, 11.2 SQL Server 2008

2010 / 2012 2013 2014 2015

SM10.0, SM10.1, SM10.2

SM10.3 SM10.4 SM10.5

2016

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SM 11.0

SM11.0 Workflows / Spreadsheet Login Subsamples, Split samples, Composite samples Attachments Syntax Enhancements / Formulas Explorer Enhancements (Find Box, Formatting

Rules, CSV Export) .Net 4.0 compatible, Significant Form Designer

and .Net API updates Dynamic Data Property Sheets Report Designer Upgrade (QR Code support) Structure Table Definition enhancements Smart Client Instance Based Licensing

2004

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

Server Windows 2008, 2012 Server

Database Oracle 11g SQL Server 2008, 2012

2010 / 2012

SM10.0, SM10.1, SM10.2

SM11.0

SM10.3 SM10.4 SM10.5

20172013 2014 2015 2016

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SM 11.1

SM11.1 Report Designer Templates / Master Templates “Mail to Operator” type printer Workflow Enhancements LIMSML Workflow Based Login 10.4 enhancements included on SM11.1 compared

to 11.0 Location hierarchy WDT Improvements Forms Designer API Improvements ADO Connection for SQL Server

SampleManager Service Monitor Access Log Enhancements

2004

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

,

Server Windows 2012 Server

Database Oracle 11g, 12C SQL Server 2008, 2012, 2014

2010 / 2012

SM10.0, SM10.1, SM10.2

SM11.0 SM11.1

20172013 2014 2015 2016

SM10.3 SM10.4 SM10.5

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SM 11.X

SM11.2 SM Mobile App SM Rest Web API Support to Virtualization License for Upgraded system (Module licenses) Modular Report Templates Enhanced Lots functionality Chromeleon Integration Multiple bug fixes and small enhancements

SM11.2.1 Minor enhancements and bug fixes SM11.2.2 Enhancements and bug fixes Scheduler Background Processes

SM11.2.3 Minor enhancements and bug fixes

2004

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

,

Server Windows 2012 Server

Database Oracle 11g, 12C SQL Server 2008, 2012, 2014

2010 / 2012

SM10.0, SM10.1, SM10.2

SM11.0 SM11.1 SM11.2,11.2.1, 11.2.2

20172013 2014 2015 2016

SM10.3 SM10.4 SM10.5

11.2.3

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SM 12

SM12 New Branding (together with SM11.2.3) Web Client Minor bug fixes and enhancements

2004

SM3.x, SM4.x, SM200X

2007 / 2008

SM2004 R1/R2

SM9.X

,

Server Windows 2012 Server

Database Oracle 11g, 12C SQL Server 2014, 2016

2010 / 2012

SM10.0, SM10.1, SM10.2

SM11.0 SM11.1 SM11.2,11.2.1, 11.2.2

SM12

20172013 2014 2015 2016

SM10.3 SM10.4 SM10.5

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SUPPORTED VERSIONS

PRODUCT VERSION PUBLIC RELEASE DATE SUPPORT END DATE

SampleManager

<= 4.1.0 15-Oct-1999 31-Dec-2004

4.2.0 18-Feb-2000 31-Mar-2005

2000 R1 05-Sep-2000 31-Dec-2005

2000 R2 18-Feb-2001 30-Jun-2007

2001 R1 08-Mar-2002 31-Dec-2007

2002 R1 28-Oct-2002 31-Mar-2009

2003 R1 26-Jun-2003 31-Mar-2009

2004 R1 02-Mar-2004 31-Mar-2009

2004 R2 16-Jun-2004 31-Dec-2011

9.0.0 31-May-2006 31-May-2006

9.0.1 01-Nov-2006 31-Dec-2011

9.1.0 19-Dec-2006 31-Dec-2011

9.2.0 13-Aug-2007 30-Sep-2012

9.2.1 26-Jun-2008 28-Jun-2014

10.0 25-Oct-2010 31-Oct-2015

10.0 SP1 22-Jul-2012 31-Jul-2016

10.0 SP2 20-Dec-2012 20-Dec-2017

10.0 SP3 10-Mar-2013 20-Dec-2017

10.0 SP4 20-Jun-2014 20-Dec-2017

10.0 SP5 31-Mar-2015 20-Dec-2017

11.0 13-Dec-2013 13-Dec-2018

SampleManager LIMS

11.1 16-Feb-2015 16-Feb-2020

11.2 26-May-2016 26-May-2021

11.2 SP1 20-Jun-2016 26-May-2021

11.2 SP2 13-Jan-2017 26-May-2021

11.2 SP3 27-Jun-2017 26-May-2021

12.0 04-May-2017 03-May-2022

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SM INSTRUMENT INTEGRATION EVOLUTION

Yukon

• De-supported on 2011

• Instrument integration to SM (by files or serial port) and was used for older versions of SM before Instrument Manager was released (for SM 9).

• It allows configuring parsing scripts using a set of predefined commands in an easy but limited way.

• Very limited options for logging or debugging.

• The software is designer for 16-bitsoperating systems so it usually consumes a lot of memory if run in 32-bits PCs, so it was usually installed on lab PCs only, sending results to the SM server

Instrument Manager

• Supported but not being enhanced within new versions

• Instrument Manager has first beenreleased with version 1.1 along with SM 9.2.1, it is currently on version 11.0 anddid not have many significant versionchanges since then, besides defectfixes

• Instrument Manager only deals withinstrument results retrieval (single direction interface) for existing tests in SM, but is really easier than IntegrationManager for configuringparsing/mapping scripts andinstruments connection.

Integration Manager

• Supported and constantly being enhanced

• Integration Manager can be used for more complex integration (not just for instruments), allowing creation of“worklist files” to be imported on theinstruments (bi-directional) and it canalso manage files and/or databaseinterfaces (for querying data directly), but the parsing/mapping scripts configuration is much more complicated than on InstrumentManager.

• Integration Manager has first beenreleased with version 1.1 in Feb 2007 and is currently on version 3.2 (compatible with SM 10.2 and higher).

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INTEGRATION MANAGER LATEST FEATURES

Workflow Agent and Workflow Designer, allowing Integration Manager to interface easily with systems that require multiple stages of import/export

IM Administration Client Enhancements to make the IM Administration Client more intuitive

Support for Microsoft SQL Server Database (and Oracle)

Access to SampleManager analyses and components to make it easier doing mappings

Communication with Watson LIMS from Thermo

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SM MODULES – SQC (VGL X .NET)

SQC (Statistic Quality Control) Module has been in existance since SM 2004. It was migrated from VGL to .NET in SM 11.2.

Main enhancements include: All forms were converted to .NET forms Better quality charts for displaying and printing Default out-of-the-box reports and trend rules (Nelson/Western) Integration with SM Workflows for firing events and creating automated reports

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SM MODULES – STABILITY (VGL X .NET)

VGL Module

.Net Stability Module is entirely new development of a Stability module

.Net Stability is incompatible with VGL Stability Completely different entities and database structure .Net version can be used together with VGL data in parallel

Features in new .Net Stability Integration with Lots of Functionality (.Net forms) Articles, Packaging Systems and Study Markets Picklists for Dispensing Pull Events Inventory Tracking Dashboards and Reports using Forms and Report Designer

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OTHER SM MODULES

PIMS The SM/PIMS (Plant Information Management System from OSI Soft) Module also exists since old versions of SM (at least SM

2004) in VGL, it is currently on version 11 and did not have many significant version changes since then.

SMIDI New version released (SMIDI 11), redisegned but still VGL. Reduces significantly the amount of customization needed and

streamlines/simplifies most of the customizations needed. New version used the new NetWeaver connector Still a hard product to be supported by Thermo Product roadmap indicates that a new and more supportable .Net version of SMIDI is in consideration for future releases

Mobile App and LES Limited functionality and customization options

Chromeleon Integration / Data Manager Available on latest versions of SM11 and SM12

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BUILDING THE BUSINESS CASE

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POLLING QUESTION #2

BUSINESS DRIVER

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BUSINESS DRIVERS

Reduction in Costs

• Hardware

• Software

• Support

Increased IT Productivity

• Support

• Upgrades

• Admin

Better User Productivity

• Reduce manual work

• Reduce downtime

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WHAT TO CONSIDER WHEN BUILDING A BUSINESS CASE FOR YOUR SAMPLEMANAGE UPGRADE

Why build a business cases for a SM upgrade? Help streamline planning and decisions for a GO/NO GO on

the upgrade

Justification Be very clear on what the company will WIN with the

upgrade (direct and indirect gains) Regulatory Requirements Bottlenecks Pain Points (Problems being addressed) Risk Reduction

COST x BENEFIT (ROI) Impacts on other systems and processes Cash Flow Changes Personnel Changes What Happens if you do nothing?

Buy-in from Stakeholders

Change Management

Process

Financial Implications

Justification (Technical and Non

Technical)

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WHAT TO CONSIDER WHEN BUILDING A BUSINESS CASE FOR YOUR SAMPLEMANAGE UPGRADE?

Financial Implications (Is the money spent justifiable?) Support contract with ThermoFisher active Resources Hardware / Architecture for your SM system Other Softwares (Thermo / Third Party)? Services (Internal Personnel /PMO/ IT /Business, Contractors)

Time away from business users (SME / training / procedures)

Change Management Process Impact on Business Units (IT, Laboratory, Management) Significant effort to build consensus

Buy-in from Stakeholders

Change Management

Process

Financial Implications

Justification (Technical and Non

Technical)

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GETTING STARTED WITH THE BUSINESS CASE (MODERATE TO COMPLEX UPGRADES)

1. Assemble the Team

2. Define in-scope business/laboratory processes and practices

3. Identify the Key Benefits / Justification• Hard saving• Soft saving

Members from all areas of the organization❖ Laboratory Management❖ IT Professional❖ Lab Personnel❖ Finance

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WHAT IS IN SCOPE? (MODERATE AND COMPLEX UPGRADES)

(1) Review the Current State

Lab workflows

Processes

SOPs

Integrations

(2) Perform Gap & Needs Analysis

Identify manual processes and practices

Prioritize the needs

Document the business requirements

(3) Define the Future State

Map out the To-Be process flows

Determine SOP impact

Document the user and functional requirements

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IDENTIFY HARD AND SOFT COST SAVINGS

Internal Operating efficiencies Hardware Labor Support Cost Quality Security Compliance License/Subscription Fees & Maintenance

External Customer/partner satisfaction Competitiveness Integration with other business systems

Possible Additional Revenue New Contracts New Capabilities

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POLLING QUESTION #3

WHEN DO YOU PLAN TO UPGRADE?

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POLLING QUESTION #4

UPGRADE RESOURCES

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Q&A

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