presentazione standard di powerpoint · lims and electronic data management in iso/iec 17025:2017,...

© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 23

Brief Introduction

Trends and future perspectives of Laboratory Informatics


Isabel Muñoz-Willery Ph.D.

- Director of International Application Specialists teams

- Operating in laboratories within regulated markets

- Project manager of lab automation, lab assays validation & lab accreditation

Roberto Castelnovo

- European Business Director leading sales, professional services and support

- Operating in manufacturing sites within regulated industries

- Program manager of international complex projects

20 years experience in Biotech & Quality

20 years experience in Lab Data Management

NL42 and Paperless Lab Academy


Our Collaborations

http://blog.nl42.com/basl-2015/

http://blog.nl42.com/basl-2015/


History of Laboratory Informatics



Once upon a time in 1895



At last, a complete 32-bit LIMS for less than $40,000

LIMS 2000 from Perkin-Elmer

Advertisements appeared within the print issues of Chem. Eng.


Growth trends



Growth trends

• Lab Informatics market expected to reach 3B$ by 2021

• CAGR is about 6%

• Major challenges for the future of Lab Informatics• Business Intelligence, data visualization, intelligent dashboards

• Infrastructure, Cloud, SaaS

• Mobile, Remote access, connectivity

• Digitalization, internet of Lab Things, integration

• Security, Integrity


Future perspective



Future perspective

Electronic data collection

Electronic decisions support

Electronic data management

Electronic data archival


Integration of specialised systems





Solution 1 Solution 2

Solution 7

Solution 8

Solution 3


Solution 6Solution 4

Solution 5

Solution 9


Vertical Solutions





Solution 1 Solution 2 Solution 3 Solution 4


Horizontal solutions




Electronic data archivalSolution 1

Solution 2

Solution 3

Solution 6 Solution 7 Solution 8



Designing Solutions

Design the solutions not the systems

Forget acronyms

Seek for integration


Begin with the end in mind


Search for Intelligent Devices


Or better… from Internet of Lab Things (IoLT)

21,300,000 results in Google already


… to the Lab in the Industry 4.0


Why Going Paperless

Reduce Time for manual transcription and related errors

Ease the Access to Data

Simplify the Review and Analysis

Allow grouping of data into Informative Reports

Ensure full Product Life Cycle data recording and traceability

Ensure Integrity of the data

Improve the efficiency in the

acquisition, management & archiving of your data


Regulatory impact



Challenges to overcome


Digitalization



Millennials in the work force


Where are we today?

Integration of lab data in a control room in 1990

Still of lot of Lab processes handled exclusively on paper


Benefits of paperless processes

Data at the benchData capture at the sourceALCOA+

Real time information sharingInterdepartmental communicationCollaborationRapid management decisions


Change management is required From

to


Get to know the Team

Email: [email protected]: (ES) + 34 629 026 621

nl42_isabel

Email: [email protected]

Cell: (IT) + 39 340 456 3204; (ES) +34 691 578 927

nl42_roberto

Join me at

Join me at

mailto:[email protected]

mailto:[email protected]

https://es.linkedin.com/in/isabelmunozwillery

https://es.linkedin.com/in/isabelmunozwillery

https://it.linkedin.com/in/robertocastelnovo

https://it.linkedin.com/in/robertocastelnovo


Mark your Calendar!

www.paperlesslabacademy.com

http://www.paperlesslabacademy.com/

Revision of ISO/IEC 17025

General requirements for the competence of testing and calibration laboratories

Sean Mac Curtain

Director Conformity Assessment and Consumer Matters

Bari, Italy

Introduction

About ISO

Founded in 1947

Independent

Non-governmental organization

Global network of national standards bodies*

One member per country

ISO membership comes withrights, benefits, obligations and good practice

*National standard body = national body most representative of standardization

163 members

21 100 +International Standards

100new standards each month

More than

100 000 experts

238technical committees

Stages and Status

Oct

2014

Vote to

revise

ISO/IEC

17025

WG 44

meeting

WG 44

meeting

CD 1

CD1

Ballot

Feb

2015Aug/Sept

2015

June

2015Feb

2016

WG 44

meeting

Result: 80% Approval;

2,606 comments

May

2016

CD2

Ballot

Dec

2016

Sep

2016

~Aug

2017

WG 44

meeting

DIS


~2,100 comments

WG 44

meeting

CD 2

DIS

Ballot


9% Negative

~1,800 comments

May

2017

WG 44

meeting

FDIS?

FDIS Ballot

August 14th

Nov

2017

Key changes

• Structure of document

• Mandatory wording

• Process approach

• Concept of risk and opportunities

• Decision rule (pass/fail)

• Information management

• Management system options

• Metrological traceability (informative)

ISO/IEC 17025 :2005

• Scope

• Normative references

• Terms and definitions

• Management requirements

• Technical requirements

• Cross reference to ISO 9001:2000

• Guidelines for establishing applications for specific fields

ISO/IEC 17025 :2017

1. Scope

2. Normative references

3. Terms and definitions

4. General requirements

5. Structural requirements

6. Resource requirements

7. Process requirements

8. Management requirements

Annex A Metrological traceability

Annex B Management system

Structure of ISO/IEC 17025

Mandatory wording or common elements of CASCO

• Impartiality

• Confidentiality

• Complaints and Appeals

• Managements systems (Option A or B)

Some preliminaries

Relationship to ISO 9001

Laboratories that conform to this International Standard will also operate generally in accordance with the principles of ISO 9001.

The changes

Scope (1)

This International Standard specifies the general requirements for

the competence, impartiality and consistent operation of

laboratories as defined in the standard.

Terms and Definition (3)

Laboratory (3.6)

body that performs one or more of the following activities:

− calibration

− testing

− sampling, associated with subsequent calibration or testing

Decision rule (3.7)

rule that describes how measurement uncertainty will be accounted for when stating conformity with a specified requirement

General requirements (4)

Impartiality (4.1)

• The organization acts and is committed to impartiality

• Impartiality of laboratory activities

• Identify risks to impartiality

• Demonstrate how it minimizes or eliminates any such risks

Confidentiality (4.2)

• Very little new changes

• Added some precision on those who are expected to keep information confidential

• Laboratory responsible for the management of all information created or obtained including confidential information

Structural requirements (5)

Structural (5.5c)

Document its procedures to the extent necessary to assure the consistent application of its activities and validity of the results.

• nowhere else in the document is “documented procedure” used

• reducing the necessary amount of documentation

Resource requirements (6)

Resource requirements (6)

No significant changes for personnel – impartial and competent

Requirement to manage all resources equipment, personnel systems etc.

Monitor and manage the laboratory environment

Process requirements (7)

Review of requests tenders and contracts (7.1.1.2 to 7.1.1.4)

It is required to :

• inform the customer when the requested method is not appropriate/outdated

• when a statement of conformity is requested the decision rule and specification is defined and communicated

• customer requested deviations shall not impact the integrity of the result

• Records of all of these

Selection, verification and validation of methods (7.2)Sampling (7.3)

No significant changes but requires the system to maintain good records

Handling of test or calibration items (7.4)

7.4.3 ……..

When the customer requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report indicating that the results may be compromised.

Technical records (7.5)

7.5.2 The laboratory shall ensure that amendments to technical records can be tracked back to either previous versions and to original observations. Both the original and amended data and files shall be kept, including indication of the altered aspects and those responsible for alterations.

Ensuring the validity of results (7.7)

• 7.7.1 addresses monitoring within the laboratory

• 7.7.2 addresses monitoring through comparing results outside the laboratory

• new requirements and more precision of wording

Management system should facilitate this.

Reporting statements of conformity (7.8.6)

Reporting statements of conformity – all new (7.8.6.1 to 7.8.6.2)

• document the decision rule used

• identify what the statement applies to (no ambiguity)

Complaints (7.9)

No significant changes except review by independent person.

Management of nonconforming work (7.10)

No significant changes

LIMS and Data Management

Control of data and information management (7.11)

This is the part of ISO/IEC 17025 that impact LIMS and data management for the laboratory the most.

LIMS and Electronic data managementGenerally requirements on:

- confidentiality of data;

- data protection;

- integrity;

- transmission;

- archiving;

- correct environmental conditions for data maintenance

are unchanged from ISO/IEC 17025:2005.

LIMS and Electronic data management

The content of the NOTE in ISO/IEC 17025:2005 (clause 5.4.7.2) and in NOTE 2 of ISO/IEC 17025:2017 (clause 7.11.2) are the same in that commercial, off-the-shelf software when used within its designed application can be considered as validated.

LIMS and Electronic data managementSome additional requirements in ISO/IEC 17025:2017 regarding validation that do need to be considered:

• ISO/IEC 17025:2017 clause 7.11.2 “whenever there are any changes, including laboratory software configuration or modifications to commercial off-the-shelf software, they shall be authorized, documented and validatedbefore implementation”

This is now mandatory (a clause) rather than in a note.


In ISO/IEC 17025:2017, clause 7.11.2 specifically makes reference to

• “data shall be validated for functionality, including the proper functioning of interfaces within the laboratory information management system(s) by the laboratory before introduction”.

This was previously included in 5.4.7.2 but more expressly stated in the 2017 version.


Things to consider when validating a LIMS where there is direct data capture from instrumentation (e.g. GCs; HPLCs; balances; etc.):.

• Is the data generated from the instrument captured in LIMS without alteration, directly from the instrument to LIMS?

• Is the data “captured” from the instrument by an automated process (i.e. no analyst intervention) or does the analyst have to “send” the data to the LIMS?

LIMS and Electronic data management• Are reports generated by the LIMS after the data acquisition? (what is sent

appears on the report ) Validated?.

• What rounding is in place? To what decimal places is the data being captured? Validated?

• Is the data compared to specifications when entered and is pass/fail criteria automatically assigned? Validated?

• Has measurement uncertainty considered in this pass/fail criteria or applicable decision rules? Has this been taken in to account in the calculation? If not why not? If so, how often is this updated?

LIMS and Electronic data management• What access levels/permissions are in place?

• How often is the data “sent/captured” and is the gap appropriate to prevent data being lost, corrupted or deleted?

• Are data deletions subject to an audit trail? Is the audit trail subject to audit by IT/QA staff ?

• Is the LIMS backed-up?

• Is the LIMS backed-up on-site or by a service provider?


The same list (with some additions) applies to a LIMS if validation is required for laboratory use (not off the shelf).


Clause 7.11.4 there is a new requirement, “when laboratory information management systems are managed and maintained off-site or through an external provider, the laboratory shall ensure that the provider or operator of the system complies with all applicable requirements of this document”.

Management system (8)

Management system (8)

• Allows for a choice between 2 options

• In addition to meeting the requirements of clauses 4 to7 of this International Standard the laboratory shall implement a management system in accordance with option A or option B.

Option A (8.1.2)

As a minimum the management system of the laboratory shall address the following:

– management system documentation (see 8.2)

– control of management system documents (see 8.3)

– control of records (see 8.4)

– actions to address risks and opportunities (see 8.5)

– improvement (see 8.6)

– corrective action (see 8.7)

– internal audits (see 8.8)

– management review (see 8.9)

Option B (8.1.3)

A laboratory that has established and maintains a management system,

• in accordance with the requirements of ISO 9001,

• and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of clauses 4 to 7 of ISO/IEC 17025

also fulfils at least the intent of the management system section requirements (8.2 - 8.9).

Great things happenwhen the world agrees

Video «Tecnologia al servizio dell’Uomo»

https://youtu.be/ystdF6jN7hc

https://youtu.be/ystdF6jN7hc

L’azienda

LEVEL OF RINA PRESENCE

170+

Offices

65+

Countries

3700

Colleagues

Il RINA è un Gruppo multinazionale che fornisce servizi di verifica, certificazione, valutazione di conformità, classificazione navale, valorizzazione ambientale, test di prodotto, supervisione in loco e dei fornitori, formazione e consulenza ingegneristica attraverso una vasta gamma di industrie e servizi.

Rina è

L’azienda

Project management

Consulting Engineering

Operation&Maintenance

Special studies

Design

Operation&Maintenance

Our services

Training

Classification

Certification

Testing

Inspection

T.I.C.* C.E.**

* Testing, Inspection, Certification**Consulting Engineering

Supporta i clienti nello sviluppo e nella gestione di iniziative a livello mondiale in diversi settori quali Shipping, Energia, Infrastrutture e Costruzioni, Logistica e Trasporti, Ambiente e Qualità, Agroalimentare e Sanità, Finanza e Pubbliche Istituzioni, attraverso società dedicate con competenze specifiche.

Rina

I LABORATORI

Laboratorio Prove Resistenza e Reazione al

Fuoco applicazioni civili e ferroviarie

Esegue le prove di resistenza al fuoco su elementi di separazione

verticali ed orizzontali non caricati, su porte e tutte le prove di

reazione al fuoco previste sia dal DM 26 Giugno 1984 del Ministero

dell’Interno sia dalla norma EN 13501-1.

Si eseguono anche prove di reazione al fuoco su materiali e

componenti per veicoli ferroviari.

ITA Istituto Tecnologie Avanzate S.r.l.

Partner per le aziende alimentari e non solo, per tutte le

esigenze che vanno dalla assistenza tecnica alle prove di

laboratorio, dall’analisi sensoriale alla ricerca e sviluppo.

Studio Sperimentale Metalsiderurgico SSM S.r.l.

Laboratorio specializzato nelle prove dei materiali, riconosciuto

da Enti di Collaudo Nazionali ed Esteri per l’esecuzione di prove

distruttive e non distruttive e tecniche ed indagini sui materiali.

Dal 1978 svolge attività al servizio dell’industria meccanica,

navale, petrolchimica ed energetica.

SSM è accreditato ACCREDIA.

LAB21

LAB21 è un Laboratorio con sede a Tunisi specializzato in analisi

microbiologiche e chimico - fisiche su cibo, acqua e altri materiali,

attraverso una rete di centri che raccolgono i campioni sul

territorio. E' accreditato per lo standard ISO/IEC 17025.

CSMCentro Sviluppo Materiali

Gruppo di Laboratori che esegue prove nei seguenti ambiti:

EUSOFT

SQL Server dbEuSoft

Inte

grat

ion

Ser

vice

s La

yer

Ap

pFa

bri

c

MS Dynamics CRM

MS Dynamics AX

SQL Server

Serv

ices

Serv

ices

Custom RINA

SQL Server dbcustom

Integration

CUSTOMERSCUSTOMERS

SUPPLIERSSUPPLIERS

CONTRACTSCONTRACTSCONTRACTS

SERVICE CATALOG

SERVICE CATALOG

PROVE

Prove terminate e

Rdp

WORK (pratica)

ORDINIORDINI

RICEVIMENTIRICEVIMENTI

Prove terminate e

Rdp

PERSONALIZZAZIONE: INTEGRAZIONE EUSOFT – DYNAMICS

EUSOFT

SQL Server dbEuSoft

Inte

grat

ion

Ser

vice

s La

yer

Ap

pFa

bri

c

MS Dynamics CRM

MS Dynamics AX

SQL Server

Serv

ices

Serv

ices

Custom RINA

SQL Server dbcustom

Integration

CUSTOMERS

CUSTOMERS

SUPPLIERS

SUPPLIERS

CONTRACTS

CONTRACTS

CONTRACTSSERVICE CATALOGSERVICE

CATALOG

PROVE

Prove terminate e

Rdp

WORK (pratica)

ORDINI

ORDINI

RICEVIMENTI

RICEVIMENTI

PERSONALIZZAZIONE: INTEGRAZIONE EUSOFT – DYNAMICS

PERSONALIZZAZIONE: GESTIONE CAMPIONI PER LABORATORI MECCANICI (SSM)

LOCALIZZAZIONE: MULTILINGUA

ROI: dati iniziali per il calcolo del ROI Laboratorio SSM

Costo annuo totale addetto laboratorio 45.000,00€

Costo orario (220 gg / anno) 28,13€

ROI: calcolo del risparmio Laboratorio SSM

AttivitàN°operazioni

/Mese

N°operazio

ni/Anno

(11 mesi)

Tempi ora

impiegati

(min)

Costo As Is

Tempi

stimati

con il

LIMS

(min)

Costo To BeRisparmio

annuo

Risparmio %

fase

Creazione saggio nel sistema 500 5500 6 15.469€ 3 7.734€ 7.734€ 50%

Stampa del Modulo di Identificazione 300 3300 0,5 773€ 0,5 773€ -€ 0%

Inserimento risultati 700 7700 10 36.094€ 7 25.266€ 10.828€ 30%

Stampa del Rapporto di Prova 700 7700 7 25.266€ 1 3.609€ 21.656€ 86%

Stoccaggio campione 500 5500 3 7.734€ 2 5.156€ 2.578€ 33%

Smaltimento campione 500 5500 5 12.891€ 2 5.156€ 7.734€ 60%

TOTALI 98.227€ 47.695€ 50.531€ 51%

Always moving forward

Agenda

150

La raffineria ISAB

Il gruppo LUKOIL: una major company Oil & Gas

Il progetto «Nuovo» LIMS

Il LIMS EUSOFT

Timeline

I numeri

I laboratori

Change Management


15

1

La Raffineria ISAB

• Una raffineria costiera localizzata in Sicilia, in una

posizione geograficamente strategica.

• Un’unica raffineria risultante dalla fusione di due impianti adiacenti:uno originariamente di proprietà ERG (Impianti Sud) e l’altro(Impianti Nord) acquistato da ERG nel 2002 da ENI.

• Oggi entrambi i siti (Sud e Nord) sono di proprietà ISAB, controllata

al 100% dal Gruppo LUKOIL dal 1° Gennaio 2014.

• È la più grande raffineria in Italia ed il più grande

esportatore di prodotti petroliferi.

151


152

Uno dei maggiori gruppi petroliferi russi. Le sue azioni sono quotate nelle borse di Londra e di Mosca.

Detiene il 2.1% della produzione mondiale di grezzo e lo 0.8% delle riserve mondiali di grezzo

La più grande società privata oil & gas nel mondo per riserve di grezzo accertate

La 4° più grande società privata oil & gas del mondo per produzione di grezzo

Detiene più di 200 società sussidiarie in 55 Paesi.

Produzione di grezzo – 114,4 mln. di tonnellate/anno.

Capacità complessiva di raffinazione attuale pari a

77,1 mln di tonnellate/anno.

Il gruppo LUKOIL: una major company Oil & Gas



153

Perché un nuovo LIMS?

Tra il 2010 ed il 2012 è stata condotta un’analisi approfondita sull’utilizzo dei sistemi di Laboratorio in ISAB che ha fornito due importanti risultati:

• Il LIMS in uso era tecnologicamente obsoleto

• Diversi requisiti non erano soddisfatti e richiedevano nuovi investimenti



154

Version

Upgrade+

Nuovi requisiti

Acquisto

Nuovo LIMS

Business Case…Effort necessario per l’upgrade di versione e per gli interventi di manutenzione evolutiva

VS

Acquisto di un nuovo sistema in grado di rispondere a tutte le esigenze



155

Analisi comparativa E’ stato ricercato un «prodotto di mercato» in grado di rispondere a tutti i requisiti necessari e da raffrontare con il sistema in uso in termini di:

• performance

• affidabilità

• livello di supporto offerto

• tempestività di risposta nell’integrazione e sviluppo di nuove funzionalità e requisiti


Il LIMS EUSOFT: Timeline

156


6 mesi di progetto

975 Utenti• 26 Analisti ISAB

• 4 Analisti Esterni

• 945 utenti in visualizzazione

550 Prodotti

1100 Punti di prelievo

2000 Tipologie di prove analitiche

127000 Campioni analizzati

900 Risultati/giorno

913000 risultati Analitici (da maggio 2014 ad oggi)

Il LIMS EUSOFT: I numeri

157


Il LIMS EUSOFT: I laboratori

158

Laboratorio ISABAnalisi Prodotti per le Spedizioni

Laboratorio EsternoAnalisi Campioni di Routine


Il LIMS EUSOFT: Architettura

159

L’architettura di EuSoft®.Lab è di tipo three-tier ("a tre strati"): architettura

software che prevede la suddivisione del sistema in tre diversi moduli dedicati

rispettivamente a:

• interfaccia utente

• logica funzionale (business logic)

• gestione dei dati persistenti


Il LIMS EUSOFT: Change Management

160

Dal certo all’incerto…

Dopo oltre 10 anni di utilizzo del precedente sistema, il passaggio al nuovo appariva rischioso e denso di insidie.

I driver per la scelta

Contatto diretto

Prossimità logistica

Tecnologia utilizzata

Assistenza nei festivi

Tempi d’intervento



161

La prima reazione dei nostri utenti…

Il cambiamento predispone al miglioramento. Il nuovo LIMS doveva superare «tutte» le carenze del vecchio e «subito». La scelta del fornitore era strategica per l’IT.



162

L’impatto del cambiamento…

Go live

Dopo 1

mese Dopo 2

mesi

Dopo 3

mesi

Oggi

presentazione standard di powerpoint · lims and electronic data management in iso/iec 17025:2017,...

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