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CAD Use in Regulated Environments |
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If paper drawings are standard and used exclusively for the approval process and for data exchange, complete validation is not absolutely necessary.
However if 3D model files are exchanged between departments or with external partners, such files are considered 'Electronic Records' for regulatory purposes. This results in an obligation to have an application validated which is used for such data exchange.
Details of our range of services:
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Inspection of workflow for product development, such as PLM, approval processes for 3D models, change request management, or development phases
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Validation of management tools, such as CAD data management, modules for controlling access rights and workflows, and all other applications modules that administrate and manage these electronic records (since they contain quality-related information)
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Checking interfaces to other applications, e.g. SAP
- Checking CAD data management, e.g. regarding security aspects (back-up and restore, archiving)
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Reviewing responsibilities (role definition and allocation)
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In the context of prospective validations, we support your decision-making process using a specification and a product/manufacturer comparison.
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