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white systemesinfo Audit and solving the problems of "data integrity" to the quality control laboratory


- Insurer Quality
- Personal computer
- Laboratory Personnel / Quality Control

• Clarify the definition of this term and expectations of regulatory authorities on the subject.
• Evaluate, through the case study of the quality control laboratory, the various risks associated with the "Data Integrity".
• Provide technical and human resources to manage those risks.
En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.
Études de cas




1 day

18 October 2017

Jean-Louis Jouve
Consultant pour l’industrie Pharma & Biotech

800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01


Observations inspection on the "Data Integrity" are becoming more numerous and concern not only emerging countries; these remarks reveal significant gaps in the management of electronic data or paper for which manufacturers must have the means of effective prevention.
The proposed training will recall the main regulatory requirements on this issue and offer, through a case study on laboratory recordings, to acquaint participants with the appropriate means of control in this area and their possible application in business


Definition (s) of the "data integrity" and related terms: life cycle of the data ...

History and regulatory references:
• Main enforceable regulations
• Examples of inspection Returns

Case study :
• Risk analysis "Data Integrity" on various data recording processlaboratory paper, direct entry, excel sheet, instrument connection management systemlaboratory...


Case study (continued)

Synthesis on how prevention: behavioral, organizational, technical ...

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

Questionnaire de satisfaction

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025




Jean-Louis Jouve
Jean Louisconsultant Trainer graduate engineer ESCIL and the University Lyon 1 in Analytical Chemistry (DEA), it is, since November 2004, manager and principal consultant Coetic, expertise and consulting firm dedicated to regulated industries (pharmaceutical, biotech, principles active pharmaceutical and medical devices).
In parallel, he has been involved in several projects of regulatory compliance of computerized and automated systems. He is also responsible ICG A3P eCompliance (Electronic Compliance) and serves on the board of A3P.
As an expert, he was invited as a speaker at several international conferences and seminars and is the author of several articles and scientific publications.

Training A3P:
SI01 - Cloud computing and drug regulation
SI02 - Audit and inspection of computerized systems: tools and methods
SI03 - Validation of effective and efficient information systems
SI04 - Evaluation of IT / IS suppliers Tools and Practices
SI05 - Audit and solving the problems of "data integrity" to the quality control laboratory


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