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.
___________________________
___________________________
___________________________
ADVICE
We support our customers in their FDA or CE certification projects.
___________________________
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.
-
Are you looking for an expert to guide you through software compliance?
-
Are you looking for an expert to advise you on compliance issues related to new technologies?
-
Are you looking for an experienced and independent consultant to manage your validation projects?
-
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.
___________________________
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.
___________________________
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?
SAP ECC, S/4HANA migration: ADN performs the CSV assessment, the functional risk analysis per module (QM, MM, PP, WM, etc.) and the entire testing strategy.
Compliant with GAMP 5 Second Edition,
21 CFR Part 11, GMP Annex 11,
ISO 13485, 21 CFR Part 820.
Deploying an ERP (Navision, Divalto, Infor, Cegid, Oracle…) in a GxP context? ADN validates your critical processes: batch management, traceability, quality control, audit trail. An approach scaled to the real risk.
Compliant with GAMP 5 Second Edition,
21 CFR Part 11, GMP Annex 11,
ISO 13485, 21 CFR Part 820.
From regulatory scoping to maintaining the validated state, ADN validates your SCADA and supervision systems in a GxP environment. Data acquisition, alarms, recipes, audit trail, process data integrity. Compliant with GAMP 5 Second Edition, 21 CFR Part 11, GMP Annex 11.
From GxP assessment to validation report, ADN qualifies your WMS (Manhattan, SAP WM/EWM, Hardis, Generix) on a time-and-materials or fixed-price basis. Receiving, storage, picking, serial traceability, cold chain, quarantine status. Compliant with GAMP 5 Second Edition, 21 CFR Part 11, GMP Annex 11.
ADN supports your Sage X3 compliance projects in a GxP environment: new implementation, version upgrade (V6, V11, V12) or revalidation. Quality modules, batch management, traceability, audit trail, etc.
Compliant with GAMP 5 Second Edition,
21 CFR Part 11, GMP Annex 11,
ISO 13485, 21 CFR Part 820.
From pre-scoping to maintaining the validated state, ADN supports your LIMS projects from the scoping study through to keeping them in a validated state. Sample management, OOS, ALCOA+ data integrity, audit trail.
Compliant with GAMP 5 Second Edition,
21 CFR Part 11, GMP Annex 11.
From impact analysis to post-upgrade qualification, ADN supports your MES projects (Rockwell, Siemens, Werum PAS-X) in pharmaceutical and medical device environments. Manufacturing orders, batch traceability, equipment management, e-batch record. Compliant with GAMP 5 Second Edition, 21 CFR Part 11, GMP Annex 11.
