COETIC votre partenaire pour la gestion et la validation de vos projets réglementés GxP

Dans le cadre de son développement, ce groupe international français recherche u n(e) responsable Assurance Qualité Informatique et un(e) chef de projet Validation Informatique ERP. Basé dans le sud-ouest de la France, ces deux postes sont à pourvoir rapidement. Si vous souhaitez des plus amples informations, contactez-nous ici .

Cette injonction contient de nombreuses violations des principes de "data integrity" : 1.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established API specifications and standards. Our investigator found that you failed to maintain complete data from all laboratory analyses, and that you relied on the incomplete information to determine whether your drugs met established specifications. For example: a.     Numerous data files were found in the recycle bin folder on the computer connected to gas chromatography instruments GC-4 and GC-6. Specifically, our investigator found deleted data for residual solvent testing for (b)(4) lot (b)(4) in the recycle bin. Your records show that you retested the lot without documented justification or an investigation. You retained only the final test result. b.    During the inspection our investigator requested residual solvent release test data for two of...

2.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Our investigators observed systemic data manipulation across your facility. They documented unexplained deletions of laboratory test results . They discovered that you repeated tests until you obtained acceptable results and that you failed to investigate out-of-specification or otherwise undesirable test result s. Your firm relied on these falsified and manipulated test results to support batch release and stability data. Your firm routinely re-tested high performance liquid chromatography (HPLC) samples and deleted previous chromatograms without justification. Your management acknowledged that employees in your quality control laboratory have access, authority, and the ability to delete and repeat HPLC injections when undesirable results were encountered prior to reporting final results... Reducing the number of ...