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NuGenesisSDMS/LMS



ISO17025:2017


General requirements for the competence of testing and calibration laboratories

Stronger focus on Information technologies

– Includes use of computer systems, electronic records, and production of electronic results and reports

Risk-based thinking

Matches latest revision of ISO 9001

Control of data

ISO 17025: 2017 Update


§7.11.3 The laboratory information management system(s) shall:

a) be protected from unauthorized access;

b) be safeguarded against tampering and loss;

c) be operated in an environment that complies with provider or laboratory specifications or, in the case of

non-computerized systems, provides conditions which safeguard the accuracy of manual recording and

transcription;

d) be maintained in a manner that ensures the integrity of the data and information;

e) include recording system failures and the appropriate immediate and corrective actions.

NOTE 1 In this document “laboratory information management system(s)” includes the management of data and information contained in both computerized and non-computerized

systems. Some of the requirements can be more applicable to computerized systems than to non-computerized systems.

NOTE 2 Commercial off-the-shelf software in general use within its designed application range can be considered to be sufficiently validated.

2017 Requirements for laboratory information

management system(s)


ALCOA+


ALCOA+

Key Factor in Data Integrity

A

Attributable Zurechenbar

L

Legible Lesbar

C

Contemporaneous Gleichzeitig

O

Original Original

A

Accurate Genau

+

Complete Komplett

Consistent Konsistent

Enduring Dauerhaft

Available Verfügbar

Stan W. Woollen, Sr. Compliance Advisor


ALCOA+

Key Factor in Data Integrity

A

Attributable Wer hat die Daten aufgenommen / die Aktion durchgeführt?

L

Legible Sind die Daten lesbar und verständlich?

C

Contemporaneous Wurden die Daten zur Zeit ihres Entstehens dokumentiert?

O

Original Sind die Daten das Orginal oder eine verifizierte Kopie?

A

Accurate Sind die Daten wissenschaftlich valide und fehlerfrei?

+

Complete Sind das alle Daten oder gibt es Wiederholungen Reanalysen

Consistent Alle Elemente der Analyse sind in Reihenfolge mit Datum/Uhrzeit versehen

Enduring In einer dauerhaften, wartbaren Form während des gesamten Lebenszyklus aufgezeichnet

Available Zur Überprüfung, Prüfung oder Inspektion über die gesamte Lebensdauer der Aufzeichnung

Stan W. Woollen, Sr. Compliance Advisor


ALCOA + ISO 17025 Requirement

Attributable§7.5.1 … technical records shall include the date and identity of

personnel responsible for each activity and for checking data and results

Legible§7.5.2 … ensure that amendments to technical records can be tracked to

previous versions or to original observations

Contemporaneous§7.5.1 Original observations, data and calculations should be recorded at the

time they are made…

Original§7.5.2 … original and amended data and files shall be retained

Accurate§7.11.3 c) … provides conditions which safeguard the accuracy of manual

recording and transcription

Hidden ALCOA+ Requirements in ISO 17025


ALCOA + ISO 17025 Requirement

Complete§7.11.3 e) include recording system failures and the appropriate immediate and

corrective actions

Consistent

§7.11.6 Calculations and data transfers shall be checked in an appropriate and

systematic manner; §7.11.2 the … system(s) used for collection, processing

recording, reporting, storage or retrieval of data … shall be validated for

functionality… including the proper functioning of interfaces

Enduring§7.11.3 b) … be safeguarded against tampering and loss

Available

§8.4.2 …shall implement the controls needed for the identification, storage,

protection, back-up, archive, retrieval, retention time, and disposal of its

records. … records shall be readily available.

Hidden ALCOA+ Requirements in ISO 17025


M2: Data Integrity Maturity Level

A stand-alone guide, that is aligned and can be used in parallel with GAMP® 5 and the

Good Practise Guides

– Based upon life sciences regulations and guidance (GCP, GMP, GLP, and medical Devices) including

recent Data Integrity Guidances, 21 CFR Part 11, Chapter 4 Annex 11, ICH Q9, & ICH Q10

– Main body consists of 5 main chapters

o Introduction

o Regulatory Focus

o Data Governance Framework

o Data Life Cycle

o Quality Risk Management

– M3 Human Factors

– M4 Data Audit Trail Review

– M5 Data Auditing and Periodic Review

ISPE GAMP® Guide:

Records and Data Integrity


e-Book

https://www.waters.com/waters/library.htm?lid=135029104&locale=101

https://www.waters.com/waters/library.htm?lid=135029104&locale=101


NuGenesis = SDMS + LMS + ELN + Inventories + Stability Module… SDMS = Scientific Data Management System

LMS = Laboratory Management System

ELN = Electronic Laboratory Notebook

NuGenesis?


But Instrument Languages Differ?

Agilent - HPLC

Waters - UPLC/MS

вы говорите

по-русски?

Parlez-

vous

français?

Does anybody

speak a

common

language?!

Bruker - NMR MDC-FLIPR

Sprechen

Sie

Deutsch?

¿Habla

Español?

Shimadzu FTIR

00I0I0I00I0I

000I0I0II0I0I

0I00I00III0I0

0I00I0

Varian - CaryUV


Labordaten


Labordaten


SDMS Oberfläche Volltextsuche


Data Search / Filter Filter


File Capture


File/Data Import

Computer

SDMS

SDMS


Messrechner

SDMS

SDMS

FileCapture


MS Data in NuGenesis


NuGenesis Patented Technology

Data Adaptors

NuGenesis Data Adaptors are a way of decoding common file types

– We have generic ones that fit all file types

– Plus some very specific ones including Empower and MassLynx

Vendor ProductWaters Corporation MassLynx & Empower

ABI-Sciex Analyst

Adobe Acrobat

Advanced Chemistry Development ACD SpecManager/ ChromManager

Agilent Technologies Agilent Chromatography ChemStation & Agilent ChemStore

BD Biosciences FACSDiVa

Bruker BioSpin XWIN-NMR & TopSpin

Bruker Daltonics XMASS

Dionex Chromeleon

MDL Isis Draw

Microsoft Microsoft Office

Perkin Elmer Turbochrom & TotalChrom

Shimadzu CLASS Agents

Thermo Finnigan Corporation Xcalibur

Thermo Fisher Scientific Atlas


Keine Datenkonvetierung möglich?


Print Capture


How can a Report get into SDMS?


Print Capture

SDMS


Wie sieht so ein Report aus?


Viewing Printed Data

Gel

Images

HPLC

Mass Spec

NMR


Electronic Signatures

Annotate data

Apply e-Signatures

Bring control to data in one

single location


Reuse Report Content


Quantify Sample Report MassLynx 4.1

Dataset: C:\Daten\2006_003.PRO\intervetapciFges.qld

Signature: Not signed

Last Altered: Monday, March 13, 2006 18:38:30 Eastern Standard Time

Printed: At Monday, March 13, 2006 18:39:07 Eastern Standard Time

By WATERS-62X73KYU\Micromass (Mass Spectrometer Instrument)

Name: intervetapci060309055, Date: 10-Mar-2006, Time: 02:52:52, ID: , Description: F 5000

PMT

min

2.00 4.00

%

0

100

F1:MRM of 3 channels,AP+

734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34

Name: intervetapci060309056, Date: 10-Mar-2006, Time: 03:01:01, ID: , Description: Acetonitril

ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20

Reusing the Data in SDMS

No transcription or cut and paste or checking

Apply on printed reports with the same layout

Automation of calculations in destination document

Subject Analyte Value

1232-C1 CQ102 13,27

1232-C2 CQ102 14,89

1232-U1 CQ102 12,72

1232-U2 CQ102 13,04

1232-C3 CQ102 13,49

1232-U3 CQ102 14,13








PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34


ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20








PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34


ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20








PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34


ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20








PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34


ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20








PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

3.217e+006PMT

1.62

242364.91

2.42e5

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

329714

2022242

Sec.Area

242365

Response

329713.625

6.133

Detecti...

bb

bb

ng/g

1

4739

%Dev

16.3

-5.2

Ion Ratio

8.34


ISTD

min

2.00 4.00

%

0

100


744.55 > 108.1

2.506e+0040.32

ISTD

1.62

935.58

9.36e2

PMT

min

2.00 4.00

%

0

100


734.55 > 98.1

1.042e+0050.32

PMT

1.62

3626.74

3.63e3

PMT

min

2.00 4.00

%

0

100


734.55 > 174.1

1.361e+0040.32

PMT

1.62

437.76

4.38e2

1

2

#

1

2

Name

ISTD

PMT

RT

1.62

1.62

Area

936

3627

Sec.Area

438

Response

935.577

3.876

Detecti...

bb

bd

ng/g

0

2993

%Dev

-99.7

Ion Ratio

8.28

Page 16 of 20

Average 13.59


Data Management

Data Retention can be Enabled on a Project

Flexible Retention Policies

Complete Manual or Automatic Deletion After Expiration

Legal Holds will Prevent Any Change or Deletion



Password Protection


The missing Compliance Tab

https://www.linkedin.com/feed/update/urn:li:activity:6328289080425746432


NuGenesis: Excel Remediation


Summary

NuGenesis LMS takes care of

– File Capture

– Print Capture

– Excel Remediation

– Automated data archival and deletion

– Report distribution and e-Signature review

– Audit trail management

– Minimising transcription errors

– Minimising or eliminating review

– Increase laboratory productive and meets regulatory and accrediation bodies expectations on records control

But it doesn‘t stop there...

Data

Management

Sample/Test

Management

Stability

Management

Paperless

Laboratory

Inventory

Management


( )

Weitere Informationen

Excel RemediationNuGenesis SDMSVitaQuest

Case Study (183% ROI)


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Documents

NuGenesis · Guidance on Waters' services and product features, including technical tips and tricks Hands-on training and Tutorial tracks to ensure your team is up to date with Waters’