thermo scientific data manager - innovatek.com.co data... · key words sdms vendor-neutral...

4
Key Words SDMS Vendor-neutral Formatting Future-proof Archiving Regulatory Compliance Seamless Data Access Data Manager gives you long-term data preservation, accessibility and retrieval of raw instrument data so you can share, compare, search, query and reuse instrument and document data across your organization. Each day, the scientific community faces the challenge of managing high volumes of scientific data. Raw data is generated by multiple disconnected instruments across the lab, in multiple formats. Data is difficult to search, share and access for reporting and reuse. Management and scientists struggle to fully leverage the company’s intellectual property. Compounding this challenge is the pace of technology, as instruments and data formats rapidly evolve. Costs are pushed higher, while the value of the data remains untapped. Technical Information Bulletin Thermo Scientific Data Manager Thermo Scientific Data Manager addresses these chal- lenges, helping laboratories realize the true value of their scientific data. Data Manager securely stores and rapidly retrieves scientific data from multiple instrument formats. Through a unique library of over 180 powerful file converters that automatically generate XML versions of the data, the archived information can be viewed on virtually any platform without using the original instru- ment software.

Upload: vuongtram

Post on 26-Aug-2018

213 views

Category:

Documents


0 download

TRANSCRIPT

Key WordsSDMS

Vendor-neutral Formatting

Future-proof Archiving

Regulatory Compliance

Seamless Data Access

Data Manager gives you long-term data preservation, accessibility and retrieval of raw instrument data so you can share, compare, search, query and reuse instrument and document data across your organization.

Each day, the scientific community faces the challenge of managing high volumes of scientific data. Raw data is generated by multiple disconnected instruments across the lab, in multiple formats. Data is difficult to search, share and access for reporting and reuse. Management and scientists struggle to fully leverage the company’s intellectual property. Compounding this challenge is the pace of technology, as instruments and data formats rapidly evolve. Costs are pushed higher, while the value of the data remains untapped.

Tech

nica

l Info

rma

tion

Bu

lletin

Thermo Scientific™ Data Manager™

Thermo Scientific Data Manager addresses these chal-lenges, helping laboratories realize the true value of their scientific data. Data Manager securely stores and rapidly retrieves scientific data from multiple instrument formats. Through a unique library of over 180 powerful file converters that automatically generate XML versions of the data, the archived information can be viewed on virtually any platform without using the original instru-ment software.

2 Centralized, Future-proof ArchivingData Manager centralizes an enterprise’s scientific data, providing financial and research benefits. The data sharing and recall capabilities of the system can aid development of new ways of reanalyzing samples and developing predictive models that are impossible when the information is scattered across the company in individual workstations and disparate formats. Data Manager is the most effective solution for protecting scientific intellectual property and extracting maximum value from an enterprise’s R&D activities.

Data Manager allows authorized users to retrieve and display specific data files without relying on the original vendor’s software, operating system or hardware. Data Manager achieves this by archiving data in a “normalized” XML-based format, providing the ability to easily retrieve original raw data or converted files and to respond much more promptly and effectively to requests from colleagues, regulatory or legal bodies.

By archiving data in a normalized XML-based format and exposing it via Data Manager’s Application Programming Interface (API), Data Manager easily integrates with existing informatics investments such as LIMS, CDS, ELN, as well as enterprise systems such as ERP. This increases the utility, value, availability and longevity of scientific data.

Delivering Connected Productivity The advantages of integrating all scientific and laboratory information into a single application are far-reaching. Through centralized archiving, Data Manager helps eliminate duplicate searches and streamlines information management throughout the organization. Data Manager is an ideal solution for capturing and managing data from analytical instru-ments and business applications, including instrument output files, certificates of analysis, research reports, product specifications, standard operating procedures (SOPs), and much more.

Data Manager connects your laboratory and enterprise data, leading to faster, more informed decisions at all levels of the organization. By removing data silos, Data Manager transforms the information produced in your lab into a valuable global asset for your organization.

Designed for Regulatory Compliance Data Manager enables compliance with Good Laboratory Practice (GLP), Good Automated Labora-tory Practice (GALP), Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) under the auspices of all major regulatory authorities, including U.S. FDA, U.S. EPA and OECD. Data Manager can be used as a critical component in laboratory solutions requiring 21 CFR Part 11 compliance.

Data Manager supports compliance by delivering comprehensive audit trailing, workstation security, operator/role/group security configurations, passwords and login security, and electronic signature functionality for signing/approving archived data.

Data Manager packages the original raw data, processed data and vendor-neutral XML for long-term storage.

Data Manager connects your laboratory

and enterprise data, leading to

faster, more informed decisions

at all levels of the organization.

3

Regulatory Drivers to Centralize Data

The penalties for improper maintenance of

records can be severe – ranging from the

closing down of a business to imprisonment

of its directors and staff for fraud. Providing

a complete data ‘chain of custody’ is

essential for R&D and law enforcement.

Research Drivers to Centralize Data

Centralized data helps protect scientific

intellectual property and extract maximum

value from an enterprise’s R&D activities.

Financial Drivers to Centralize Data

International Data Corp. (IDC) estimated

that poorly managed knowledge costs

the U.S. Fortune 500 companies alone

about $12 billion a year. Substandard

performance, intellectual rework, and

the lack of available knowledge

management resources were identified

by IDC as the key causes of this cost.

How does Data Manager work?

• Based upon user-defined rules, Data Manager sweeps the instrument file system or database and packages all new or updated raw data and reports. This data package is transferred securely to the specified data repository.

• Proprietary converters understand the specific raw data format and render an accurate, normalized copy of the raw data in a vendor-neutral XML format.

• Descriptive metadata is extracted from the raw data and XML via user-defined rules and stored in the database as properties of the data package to aid structured retrieval (e.g., date/time created, analyst, application type, sample name, component names, batch, LIMS ID, etc.)

• Data items can be rapidly found through structured or unstructured queries using the user interface or 3rd party applications via the Data Manager API.

• The recalled raw data can be re-processed in the original system. Or, the normalized XML data may be viewed, reported and processed via the web, tablet or applications such as GRAMS/AI, OMNIC™ and Chromeleon™.

• Data Manager can be configured to capture a relevant text document or PDF along with the actual instrument data. Once the instrument data files are gathered, they are moved to the server. There, the appropriate converter creates an XML copy that is stored alongside the original data and indexed in a secure file store.

• File stores may be geographically distributed, while the indexes are stored centrally. This reduces the need for file transfer while maintain-ing the benefits of a global system. Data Manager viewers such as GRAMS Envision™ lend themselves to remote deployment solutions, such as Citrix® or Thermo Scientific Web Access, that further reduce the need for file transfer.

10%

12%

30%

38%

10%

Maximizing Data Analytics

Interdepartmental & Intercompany Accessibility of

Maximizing Data Integrating the Systems

Change Management

> > > > > > > > > > > > > > > > > >

> > > > > > > > >

< < < < < < < < < < < < < < <

< < < < < < < < < < <

< < < < < < < <

Manipulation of Data

Your Laboratory Informatics Challenges

Use Data Manager, Integration Manager and SampleManager together as an integrated platform to address your laboratory informatics challenges.

Tech

nica

l Info

rma

tion

Bu

lletin

For more information about Data Manager, visit www.thermofisher.com/informatics or email us at [email protected]

© 2016 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. All other trademarks and copyrights are property of their respective owners. Specifications, terms and pricing are subject to change. Not all products are available in all countries. Please consult your local sales representative for details.

Australia/Asia Pacific +61 8 8208 8200China +86 800 810 5118France +33 160924800Germany/Eastern Europe +49 6103 408 1110India +91 22 6742 94 94

Latin America and the Caribbean +1 781 933 4689Netherlands/Benelux +31 76 579 5555Spain/Portugal +34 914 845 965United Kingdom +44 1619423000USA/North America +1 800 395 5467

DataManager-TIB316

Handy Web LinksTechnical Bulletins

Additional Resources

p Thermo Scientific SampleManager LIMS

Key WordsIntegrated LIMS and CDS

Secure & Compliant Interface

Workflows to Drive the Lab Process

Multi-Vendor Instrument Support

Centralized Chromatography & Mass Spectroscopy Data Processing & Management

Sophisticated Data Visualization

Paperless Lab

The Chromeleon link options are available from the top menu bar on the home page, as well as via a convenient Explorer Cabinet where all Chromeleon Link-related data and options can be found.

SampleManager LIMS delivers the most complete Informatics solution available, including functionality for method execution, laboratory and scientific data manage-ment. Built into the latest version of SampleManager and unique to Thermo Fisher Scientific, are LIMS, SDMS and LES functionality on one platform, saving lab managers the time and expense of purchasing and maintaining software from multiple suppliers. SampleManager LIMS is also fully integrated with Chromeleon CDS, providing a seamless CDS link within the LIMS to streamline the lab process and eliminate manual steps related to sample testing and results capture and analysis. The integration of SampleManager LIMS with Chromeleon CDS gives users access to all LC, GC, IC and MS data within the same platform and user environment, simplifying training of personnel and reducing operating costs.

Both SampleManager LIMS and Chromeleon CDS deliver workflow capabilities so the system is simple to manage and maintain without relying on external IT or program-ming resources.

Unique to the SampleManager LIMS and Chromeleon CDS link, users will have full capability to monitor queue status and instrument health from the LIMS, giving users the ability to assign work more effectively and allow for instrument maintenance as required. The instrument notifies users of impending service, allowing the lab to schedule workload more effectively and improve instru-ment utilization. The instrument notifies users of potential wear part failure, allowing the lab to schedule instrument maintenance at the most convenient time and improving instrument uptime. Information is stored in the instru-ment firmware, ensuring data is recorded and maintained at all times, even if a module is moved/exchanged. The SampleManager LIMS and Chromeleon CDS link gives users an out-of-the-box interface supported by one

Tech

nica

l Info

rma

tion

Bu

lletin

Thermo Scientific™ SampleManager LIMS™ and Thermo Scientific™ Dionex™ Chromeleon™ CDS Link

p Thermo Scientific SampleManager LIMS and Dionex Chromeleon CDS Link

p Thermo Scientific Integration Manager

Da

ta S

he

et

Thermo Scientific™ CONNECTS™ for the Paperless Lab is a combined methodology, technology and services offering that transforms laboratories into tightly integrated paperless environments.

• Getreal-timeaccesstoinformation

• Improveregulatorycomplianceand data integrity

• Automateprocessesandreduce manualdatahandling

I N F O R M A T I C S

Thermo Scientific CONNECTS for the Paperless Lab

CONNECTS for the Paperless Lab delivers the methodology, technology and services necessary to transform today’s laboratories into tightly integrated paperless environments, while leveraging existing investments in software systems, databases and laboratory instrumentation from a wide variety of commercial vendors.

By bridging the islands of data generated in the lab and transforming that data into information that can be used across the enterprise, organizations will reap the benefits of improved access to real-time information, regulatory compliance, data integrity, as well as time and cost savings by automating processes and reducing manual data handling.

CONNECTS for the Paperless Lab is comprised of three unique components — methodology, technology and services — that combined deliver seamless and continuous

data flows from the lab into the enterprise, improving results analysis, enabling faster decision making and improving productivity.

Building on a history of informatics innovations, CONNECTS provides access to all instrument data via a single interface and allows real-time analysis and investigation of results. The technology converts raw data to a vendor independent XML storage format to ensure future proof data archiving and facilitate data and information sharing across the organization, without having to rely on access to the original application. CONNECTS technology acts as a ‘translator’ of all the individual languages of the lab’s disparate instruments and is able to deliver and accept data in the format appropriate for each instrument.

Delivering the Paperless Lab Environment

Did you know? By automating the laboratory, companies save a tremendous

amount of time and resources on manual activities in the lab. By automating the lab, CONNECTS for the Paperless Lab

delivers improved efficiency, productivity, consistency, quality and reduced costs

typically by over 20%.

ConneCts for the

Paperless Lab

p Thermo Scientific CONNECTS for the Paperless Lab

p Thermo Scientific SampleManager LIMS

Online Library of Analytical Applications

p Thermo Scientific Chromatography Data Systems

p Thermo Scientific Dionex™ Chromeleon™ Chromatography Data System

p CONNECTS for the Paperless Lab