COMPUTERIZED SYSTEM VALIDATION
SOFTWARE VALIDATION
ISO 13485: 2016 - ISO / TR 80002-2, IEC 62304, 21 CFR Part 11
GAMP 5 Second edition, Computer Software Assurance 2025
GxP Systems - Annex 11 - Annex 22
V-Cycle - Agile - DevOps
Give value to your validation!
Optimize your validation times in complete safety
Gain in the quality of deliverables
Accelerate the value brought to your business teams
Rely on an experienced consultant to support you in your risk-based validation strategy, and guarantee the success of your FDA, EMA, ISO 13485 or 62304 projects.
Rely on an experienced consultant combining business knowledge and standards or regulations, to write the deliverables strictly necessary for the control of patient risks or critical data.
Intensify your ability to validate more releases with the same resources, thanks to our regulatory or normative approach to Agility in a DevOps context.
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ADVICE
We support our customers in their FDA or CE certification projects.
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Do you have a new software product to register on the market? A new computerized system to be brought into compliance with FDA or 13485?
For 30 years, we have acquired both the experience, the hindsight and the technical expertise to help you meet the challenges related to this technological wave.
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Are you looking for an expert to guide you through software compliance?
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Are you looking for an expert to advise you on compliance issues related to new technologies?
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Are you looking for an experienced and independent consultant to manage your validation projects?
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Are you looking for a LIMS project manager ?
Let's discuss your computerized systems projects
Let's discuss your software validation projects
SOFTWARE INTEGRATION
We support our customers in the dematerialization of their validation.
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Do you want to gain speed and traceability for your validations? Is electronic signature becoming essential in your telecommuting context?
For 30 years, we have acquired the experience of dematerialization on a large number of projects, and software of the ALM or Agile type.
Are you looking for an ALM GxP expert ? an Xray Expert ?
Are you looking for an Agile or DevOps expert, with 62304 or GXP experience?
Looking for advice on how to conduct a paperless validation transformation?
Let's discuss your projects
TRAINING
We offer our clients validation-oriented training in a context pharmaceutical or medical device.
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Software validation is a profession in its own right, which has evolved very quickly under the spotlight of recent and future digital transformations.
If the classic validation based on Cycle V remains the most widespread, the rise of Agility is undeniable and draws a set of training needs.
Are you looking for a traditional validation training, Cycle in V, type Gamp 5?
Are you looking for an Agile Validation training?
Migration SAP ECC, S/4HANA : ADN réalise le diagnostic VSI, l'analyse de risque fonctionnelle par module (QM, MM, PP, WM, etc.) et l'ensemble de la stratégie de tests.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11,
ISO 13485, 21 CFR Part 820.
Vous déployez un ERP (Navision, Divalto, Infor, Cegid, Oracle…) en contexte GxP ? ADN valide vos processus critiques : gestion des lots, traçabilité, contrôle qualité, audit trail. Approche proportionnée au risque réel.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11,
ISO 13485, 21 CFR Part 820.
Du cadrage réglementaire au maintien de l'état validé, ADN valide vos systèmes SCADA et de supervision en environnement GxP. Acquisition de données, alarmes, recettes, audit trail, intégrité des données process.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11.
ADN accompagne vos projets de mise en conformité Sage X3 en environnement GxP : nouvelle implémentation, upgrade de version (V6, V11, V12) ou revalidation. Modules qualité, gestion des lots, traçabilité, audit trail, etc.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11,
ISO 13485, 21 CFR Part 820.
Du pré-scoping au maintien de l'état validé, ADN accompagne vos projets LIMS depuis l'étude de cadrage jusqu'au maintien en état validé. Gestion des échantillons, OOS, intégrité des données ALCOA+, audit trail.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11.
De l'analyse d'impact à la qualification post-upgrade, ADN accompagne vos projets MES (Rockwell, Siemens, Werum PAS-X) en environnement pharmaceutique et dispositifs médicaux. Ordres de fabrication, traçabilité lots, gestion des équipements, e-batch record.
Conforme GAMP 5 2e édition,
21 CFR Part 11, GMP Annexe 11.
