Overview
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ABSTRACT
The purpose of a laboratory information management system (LIMS) is to increase the reliability of the data transmitted to the client in an analysis report. During its deployment, the major challenge is to permanently maintain the quality of the data and ensure their confidentiality, integrity, availability and secure storage. The article offers project leaders a guide to facilitate the achievement of LIMS qualification, maintaining its performance during updates, and mastering outsourcing. It also addresses the normative requirements relating to data relating to accreditation.
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Didier BOZONNET: Senior consultant in management systems and metrology - Manager of Bozonnet Didier: certified training organization, ICA auditor, Hérouville Saint-Clair, France
INTRODUCTION
Deploying a Laboratory Information Management System (LIMS) involves much more than signing a set of specifications and briefly checking functionality once the software has been installed.
In the context of Industry 4.0, where data reliability is becoming a major issue, so that any company can add value to it, and use it to make the right decisions, its veracity needs to be demonstrated at all times.
In another context, where the risk of malicious intent hangs over every company in every sector, the security and safety of the information systems that process this data must also be guaranteed.
This article proposes a methodology for laboratories wishing to set up a LIMS, or to maintain an existing LIMS, which will enable them to maintain data quality, and to optimize the security of the information systems interacting with the LIMS.
This methodology is characterized by a project approach, and by a qualification process, from design to performance. Standards, beyond their normative nature, provide invaluable assistance in implementing this methodology. In a way, their recommendations are no more and no less than proposals arising from a risk analysis in a given activity: quality, environment, calibration and testing, or medical biology laboratories. The proposed approach is also designed to keep LIMS maintenance agile.
IT security requirements are also addressed. The essential points to be taken into account, particularly in the case of outsourcing, are presented. The skills of an information systems security manager will help ensure the success of the implementation phase.
This article will not go into the specific requirements of medical device software, although the qualification process can be applied to them, as well as the tools proposed to ensure traceability of the qualification process.
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KEYWORDS
accreditation | medical device | laboratory | biobank | medical biology | LIMS
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Laboratory quality and safety procedures
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Performance and security of a Laboratory Information Management System (LIMS)
Bibliography
Standards and norms
- Quality management systems – Basic principles and vocabulary. - ISO 9000 - 2015
- Quality management systems – Requirements - ISO 9001 - 2015
- Conformity assessment – Vocabulary and general principles. - ISO/IEC 17000 - 2020
- Safety and resilience – Business continuity management systems – Requirements - ISO 22301 - 2019
- Exigences générales concernant la compétence des laboratoires d'étalonnages...
Regulations
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (2016)
Law no. 2018-493 of June 20, 2018 on the protection of personal data
Directory
Laboratories – Design offices – Schools – Research centers (non-exhaustive list)
French Information Systems Security Agency (ANSSI) https://www.ssi.gouv.fr/
French Data Protection Authority (CNIL) https://www.cnil.fr/fr
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