presentazione standard di powerpoint · lims and electronic data management in iso/iec 17025:2017,...
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 23
Brief Introduction
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 24
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
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 25
Our Collaborations
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 26
History of Laboratory Informatics
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 27
Once upon a time in 1895
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 28
Once upon a time in 1897
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 29
Once upon a time in 1974
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 30
Once upon a time in 1985
At last, a complete 32-bit LIMS for less than $40,000
LIMS 2000 from Perkin-Elmer
Advertisements appeared within the print issues of Chem. Eng.
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 31
Growth trends
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 32
Growth trends
• Lab Informatics market expected to reach 3B$ 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
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 33
Future perspective
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 34
Future perspective
Electronic data collection
Electronic decisions support
Electronic data management
Electronic data archival
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 35
Integration of specialised systems
Electronic data collection
Electronic decisions support
Electronic data management
Electronic data archival
Solution 1 Solution 2
Solution 7
Solution 8
Solution 3
Solution 10 Solution 11
Solution 6Solution 4
Solution 5
Solution 9
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 36
Vertical Solutions
Electronic data collection
Electronic decisions support
Electronic data management
Electronic data archival
Solution 1 Solution 2 Solution 3 Solution 4
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 37
Horizontal solutions
Electronic data collection
Electronic decisions support
Electronic data management
Electronic data archivalSolution 1
Solution 2
Solution 3
Solution 6 Solution 7 Solution 8
Solution 4 Solution 5
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 38
Designing Solutions
Design the solutions not the systems
Forget acronyms
Seek for integration
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 39
Begin with the end in mind
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 40
Search for Intelligent Devices
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 41
Or better… from Internet of Lab Things (IoLT)
21,300,000 results in Google already
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 42
… to the Lab in the Industry 4.0
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 43
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
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 44
Regulatory impact
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 45
Challenges to overcome
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 46
Digitalization
Trends and future perspectives of Laboratory Informatics
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 47
Millennials in the work force
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 48
Where are we today?
Integration of lab data in a control room in 1990
Still of lot of Lab processes handled exclusively on paper
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 49
Benefits of paperless processes
Data at the benchData capture at the sourceALCOA+
Real time information sharingInterdepartmental communicationCollaborationRapid management decisions
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 50
Change management is required From
to
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 51
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
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© 2017 | NL42 Consulting | Paperless Lab Academy 3-oct-17 52
Mark your Calendar!
www.paperlesslabacademy.com
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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
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Introduction
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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
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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
Result: 96% Approval;
~2,100 comments
WG 44
meeting
CD 2
DIS
Ballot
Result: 91% Approval;
9% Negative
~1,800 comments
May
2017
WG 44
meeting
FDIS?
FDIS Ballot
August 14th
Nov
2017
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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)
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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
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Mandatory wording or common elements of CASCO
• Impartiality
• Confidentiality
• Complaints and Appeals
• Managements systems (Option A or B)
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Some preliminaries
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Relationship to ISO 9001
Laboratories that conform to this International Standard will also operate generally in accordance with the principles of ISO 9001.
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The changes
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Scope (1)
This International Standard specifies the general requirements for
the competence, impartiality and consistent operation of
laboratories as defined in the standard.
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Terms and Definition (3)
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Laboratory (3.6)
body that performs one or more of the following activities:
− calibration
− testing
− sampling, associated with subsequent calibration or testing
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Decision rule (3.7)
rule that describes how measurement uncertainty will be accounted for when stating conformity with a specified requirement
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General requirements (4)
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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
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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
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Structural requirements (5)
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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
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Resource requirements (6)
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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
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Process requirements (7)
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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
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Selection, verification and validation of methods (7.2)Sampling (7.3)
No significant changes but requires the system to maintain good records
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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.
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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.
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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.
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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)
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Complaints (7.9)
No significant changes except review by independent person.
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Management of nonconforming work (7.10)
No significant changes
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LIMS and Data Management
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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.
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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.
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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.
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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.
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LIMS and Electronic data management
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.
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LIMS and Electronic data management
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?
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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?
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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?
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LIMS and Electronic data management
The same list (with some additions) applies to a LIMS if validation is required for laboratory use (not off the shelf).
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LIMS and Electronic data management
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”.
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Management system (8)
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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.
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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)
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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).
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Great things happenwhen the world agrees
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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
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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
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PERSONALIZZAZIONE: GESTIONE CAMPIONI PER LABORATORI MECCANICI (SSM)
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PERSONALIZZAZIONE: GESTIONE CAMPIONI PER LABORATORI MECCANICI (SSM)
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LOCALIZZAZIONE: MULTILINGUA
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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€
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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%
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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
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Always moving forward
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
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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
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Il progetto «Nuovo» LIMS
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
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Il progetto «Nuovo» LIMS
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
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Il progetto «Nuovo» LIMS
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
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Always moving forward
Il LIMS EUSOFT: Timeline
156
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Always moving forward
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
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Il LIMS EUSOFT: I laboratori
158
Laboratorio ISABAnalisi Prodotti per le Spedizioni
Laboratorio EsternoAnalisi Campioni di Routine
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Always moving forward
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
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Always moving forward
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
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Il LIMS EUSOFT: Change Management
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.
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Always moving forward
Il LIMS EUSOFT: Change Management
162
L’impatto del cambiamento…
Go live
Dopo 1
mese Dopo 2
mesi
Dopo 3
mesi
Oggi
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