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==Introduction== | ==Introduction== | ||
While [[ISO/IEC 17025]] provides numerous benefits to a [[laboratory]], it still asks a lot of the laboratory in order to conform with the standard.<ref name="DouglasHowISO23">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:How_does_ISO/IEC_17025_impact_laboratories? |title=LIMS FAQ:How does ISO/IEC 17025 impact laboratories? |work=LIMSwiki |author=Douglas, S.E. |date=January 2023 |accessdate=14 January 2023}}</ref> Today, conforming to ISO/IEC 17025 without the help of an [[information management]] system is a daunting task, especially given requirements concerning timely data retrieval and security. Labs have increasingly turned to a [[laboratory information management system]] (LIMS), not only for helping to modernize and improve the quality of the laboratory but also aiding with compliance to standards like ISO/IEC 17025.<ref>{{Citation |last=Boyar |first=Kyle |last2=Pham |first2=Andrew |last3=Swantek |first3=Shannon |last4=Ward |first4=Gary |last5=Herman |first5=Gary |date=2021 |editor-last=Opie |editor-first=Shaun R. |title=Laboratory Information Management Systems (LIMS) |url=http://link.springer.com/10.1007/978-3-030-62716-4_7 |work=Cannabis Laboratory Fundamentals |language=en |publisher=Springer International Publishing |place=Cham |pages=131–151 |doi=10.1007/978-3-030-62716-4_7 |isbn=978-3-030-62715-7 |accessdate=2023-01-14}}</ref><ref name="ApteIsYour20">{{cite web |url=https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/ |title=Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit? |author=Apte, A. |work=Food Safety Tech |date=20 October 2020 |accessdate=14 January 2023}}</ref> However, not all LIMS are built the same, and the laboratory must consider LIMS vendors who provide a solution that best helps them limit the burden of ISO/IEC 17025 compliance. | |||
This article will turn to [[LII:LIMSpec 2022 R2|LIMSpec]]—a [[laboratory informatics]] requirements specification document that has evolved significantly over the years—for input into what | This article will turn to [[LII:LIMSpec 2022 R2|LIMSpec]]—a [[laboratory informatics]] requirements specification document that has evolved significantly over the years—for input into what critical requirements of a LIMS are in regards to better complying with ISO/IEC 17025. With the current version of LIMSpec having at its core standards such as [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''<ref name="ASTME1578_18">{{cite web |url=https://www.astm.org/e1578-18.html |title=ASTM E1578-18 Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=14 January 2023}}</ref> and ISO/IEC 17025 ''Testing and calibration laboratories''<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=14 January 2023}}</ref>, the LIMSpec makes for a durable requirements document that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more. | ||
In particular, this brief article will look at the touch points of ISO/IEC 17025 with LIMSpec and highlight their importance. But before we get into specific requirements, let's take a brief look at the connection between a laboratory informatics solution like a LIMS and managing quality in the laboratory. | |||
==LIMS and quality management== | ==LIMS and quality management== | ||
| Line 176: | Line 179: | ||
| style="padding:10px;" |ISO/IEC 17025:2017 7.11.2 | | style="padding:10px;" |ISO/IEC 17025:2017 7.11.2 | ||
| style="padding:10px; background-color:white;" |'''33.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records. | | style="padding:10px; background-color:white;" |'''33.5''' The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records. | ||
| style="padding:10px; background-color:white;" |'''LIMS validation''': A laboratory can better comply with ISO/IEC 17025 requirements if the lab's LIMS is properly validated by the LIMS vendor, initially, and revalidated periodically, especially after significant updates and customization to the LIMS. This is true for any lab, but it remains especially true in regulated industries, where the accuracy, consistency, and reliability of system performance is mission-critical.<ref name="MaxwellUsing03">{{cite web |url=http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx |archiveurl=https://web.archive.org/web/20090807034051/http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx |title=Using Workflows in LIMS to Reduce Customization |author=Maxwell, G. |work=Scientific Computing |date=01 November 2003 |archivedate=07 August 2009 |accessdate=14 January 2023}}</ref> | | style="padding:10px; background-color:white;" |'''LIMS validation''': A laboratory can better comply with ISO/IEC 17025 requirements if the lab's LIMS is properly validated by the LIMS vendor, initially, and revalidated periodically, especially after significant updates and customization to the LIMS. This is true for any lab, but it remains especially true in regulated industries, where the accuracy, consistency, and reliability of system performance is mission-critical.<ref name="MaxwellUsing03">{{cite web |url=http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx |archiveurl=https://web.archive.org/web/20090807034051/http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx |title=Using Workflows in LIMS to Reduce Customization |author=Maxwell, G. |work=Scientific Computing |date=01 November 2003 |archivedate=07 August 2009 |accessdate=14 January 2023}}</ref> | ||
|- | |- | ||
| style="padding:10px;" |ISO/IEC 17025:2017 7.8.7.1<br />ISO/IEC 17025:2017 7.11.3<br />ISO/IEC 17025:2017 8.3.2 | | style="padding:10px;" |ISO/IEC 17025:2017 7.8.7.1<br />ISO/IEC 17025:2017 7.11.3<br />ISO/IEC 17025:2017 8.3.2 | ||
| Line 193: | Line 196: | ||
'''Test, sample and result management''' | '''Test, sample and result management''' | ||
* Complete capture of a registered sample's data and metadata | *Complete capture of a registered sample's data and metadata | ||
* Unique sample identifiers | *Unique sample identifiers | ||
* Free-form reception-based sample data | *Free-form reception-based sample data | ||
* Barcode and RFID support | *Barcode and RFID support | ||
* Preloaded and configurable sample types and analytical test methods | *Preloaded and configurable sample types and analytical test methods | ||
* Robust sampling and test method development | *Robust sampling and test method development | ||
'''Quality, security, and compliance''' | '''Quality, security, and compliance''' | ||
* Multi-level review of test results | *Multi-level review of test results | ||
* Validation of sampling and test methods | *Validation of sampling and test methods | ||
* Support for mapping professional requirements to existing system tasks, sample types, and methods | *Support for mapping professional requirements to existing system tasks, sample types, and methods | ||
* Instrument lock-out | *Instrument lock-out | ||
* Consistent, retrievable calibration and maintenance records | *Consistent, retrievable calibration and maintenance records | ||
* Calibration activity linkages | *Calibration activity linkages | ||
* Calibration and maintenance audit trail | *Calibration and maintenance audit trail | ||
* Nonconformance and deviation tracking | *Nonconformance and deviation tracking | ||
* Statistical trending and control charts | *Statistical trending and control charts | ||
* Internal and external audit management | *Internal and external audit management | ||
* Secure backup and retrieval | *Secure backup and retrieval | ||
* Facility monitoring | *Facility monitoring | ||
* Environmental monitoring | *Environmental monitoring | ||
* Data retention | *Data retention | ||
* Robust system security | *Robust system security | ||
* LIMS validation | *LIMS validation | ||
* Secure granular access | *Secure granular access | ||
* Logical and physical access control | *Logical and physical access control | ||
'''Operations management and reporting''' | '''Operations management and reporting''' | ||
* Document management, with versioning and release controls | *Document management, with versioning and release controls | ||
* Controlled document access | *Controlled document access | ||
* Provision of the most current document version | *Provision of the most current document version | ||
* User manuals and training documentation | *User manuals and training documentation | ||
* Support for unique document identifiers | *Support for unique document identifiers | ||
* Support for training and certification records | *Support for training and certification records | ||
* Complaint and problem management | *Complaint and problem management | ||
* Unique identification of instruments | *Unique identification of instruments | ||
* Support for scheduled, frequency-based calibration and maintenance | *Support for scheduled, frequency-based calibration and maintenance | ||
* Support for data and metadata archiving | *Support for data and metadata archiving | ||
* Support for rapid and accurate retrieval of archived data and metadata | *Support for rapid and accurate retrieval of archived data and metadata | ||
* Support for certificates of analysis or similar verification documents | *Support for certificates of analysis or similar verification documents | ||
* Support for changed, amended, or re-issued reports | *Support for changed, amended, or re-issued reports | ||
Revision as of 18:21, 14 January 2023
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This is sublevel17 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
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Title: What are the key elements of a LIMS to better comply with ISO/IEC 17025?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: TBD
Introduction
While ISO/IEC 17025 provides numerous benefits to a laboratory, it still asks a lot of the laboratory in order to conform with the standard.[1] Today, conforming to ISO/IEC 17025 without the help of an information management system is a daunting task, especially given requirements concerning timely data retrieval and security. Labs have increasingly turned to a laboratory information management system (LIMS), not only for helping to modernize and improve the quality of the laboratory but also aiding with compliance to standards like ISO/IEC 17025.[2][3] However, not all LIMS are built the same, and the laboratory must consider LIMS vendors who provide a solution that best helps them limit the burden of ISO/IEC 17025 compliance.
This article will turn to LIMSpec—a laboratory informatics requirements specification document that has evolved significantly over the years—for input into what critical requirements of a LIMS are in regards to better complying with ISO/IEC 17025. With the current version of LIMSpec having at its core standards such as ASTM E1578-18 Standard Guide for Laboratory Informatics[4] and ISO/IEC 17025 Testing and calibration laboratories[5], the LIMSpec makes for a durable requirements document that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more.
In particular, this brief article will look at the touch points of ISO/IEC 17025 with LIMSpec and highlight their importance. But before we get into specific requirements, let's take a brief look at the connection between a laboratory informatics solution like a LIMS and managing quality in the laboratory.
LIMS and quality management
ISO/IEC 17025 and its connection to various LIMS requirements
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In other words, Table 1 would indicate the following functionality as important to a lab attempting to conform to ISO/IEC 17025:
Test, sample and result management
- Complete capture of a registered sample's data and metadata
- Unique sample identifiers
- Free-form reception-based sample data
- Barcode and RFID support
- Preloaded and configurable sample types and analytical test methods
- Robust sampling and test method development
Quality, security, and compliance
- Multi-level review of test results
- Validation of sampling and test methods
- Support for mapping professional requirements to existing system tasks, sample types, and methods
- Instrument lock-out
- Consistent, retrievable calibration and maintenance records
- Calibration activity linkages
- Calibration and maintenance audit trail
- Nonconformance and deviation tracking
- Statistical trending and control charts
- Internal and external audit management
- Secure backup and retrieval
- Facility monitoring
- Environmental monitoring
- Data retention
- Robust system security
- LIMS validation
- Secure granular access
- Logical and physical access control
Operations management and reporting
- Document management, with versioning and release controls
- Controlled document access
- Provision of the most current document version
- User manuals and training documentation
- Support for unique document identifiers
- Support for training and certification records
- Complaint and problem management
- Unique identification of instruments
- Support for scheduled, frequency-based calibration and maintenance
- Support for data and metadata archiving
- Support for rapid and accurate retrieval of archived data and metadata
- Support for certificates of analysis or similar verification documents
- Support for changed, amended, or re-issued reports
Conclusion
References
- ↑ Douglas, S.E. (January 2023). "LIMS FAQ:How does ISO/IEC 17025 impact laboratories?". LIMSwiki. https://www.limswiki.org/index.php/LIMS_FAQ:How_does_ISO/IEC_17025_impact_laboratories?. Retrieved 14 January 2023.
- ↑ Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., "Laboratory Information Management Systems (LIMS)" (in en), Cannabis Laboratory Fundamentals (Cham: Springer International Publishing): 131–151, doi:10.1007/978-3-030-62716-4_7, ISBN 978-3-030-62715-7, http://link.springer.com/10.1007/978-3-030-62716-4_7. Retrieved 2023-01-14
- ↑ Apte, A. (20 October 2020). "Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?". Food Safety Tech. https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/. Retrieved 14 January 2023.
- ↑ "ASTM E1578-18 Standard Guide for Laboratory Informatics". ASTM International. 23 August 2019. https://www.astm.org/e1578-18.html. Retrieved 14 January 2023.
- ↑ "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 14 January 2023.
- ↑ Sanchez, Juan M. (11 May 2021). "Use of Control Charts and Scientific Critical Thinking in Experimental Laboratory Courses: How They Help Students to Detect and Solve Systematic Errors" (in en). Journal of Chemical Education 98 (5): 1822–1828. doi:10.1021/acs.jchemed.0c00885. ISSN 0021-9584. https://pubs.acs.org/doi/10.1021/acs.jchemed.0c00885.
- ↑ Maxwell, G. (1 November 2003). "Using Workflows in LIMS to Reduce Customization". Scientific Computing. Archived from the original on 07 August 2009. https://web.archive.org/web/20090807034051/http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx. Retrieved 14 January 2023.
