Validation for computerized/automated systems
Are you a machine building company which realizes a project in the pharma, medical, or dental domains where your resources or skills are limited ?
Or a regulated pharma or medical company with limited resources for the qualification of machine, or missing skills in automation for the qualification of an industrial machine ?
In the pharma, medical, and dental domains, Bepm Automation helps his clients during the validation process, from the User Requirements Specification (URS) up to the required Performance Qualification Tests (PQ), through all documentation (FS, DS), analysis (pFMEA) and verification (IQ, OQ) stages defined by the standards in force.
For that, Bepm Automation uses methods recommended by the ISPE organization through GAMP5®.
You build a machine for the pharmaceutical, medical, or dental domains. Your customer requires you to comply with Good Automated Manufacturing Practices (GAMP®) as defined by ISPE organization ? It's normal ! Your customer must ensure the patient security. For a machine builder, this means
Reduce the risks related to the product quality to an acceptable level, and
Ensure the integrity of the data related to the manufacturing of the product.
Those are the main topics which will concern you during all the project stages.
Bepm Automation assists you during your project in order to reduce the validation activities to essential needs, while complying with your client requirements. Thanks to its experience in control system projects for medical devices manufacturing machines, Bepm Automation brings you the required knowledge to successfully complete your project.
The main validation activities will particularly be :
Writing of functional and design specification
Functional risk assessment
Writing and execution of units, integration, and functional tests defined by the risk assessment
You are a regulated company active in the pharma, medical, or dental domains. You integrate a new production machine or line on one of your sites.
At the forefront in your core business, you may lack resources in the computerized systems, where validation requires more and more effort.
The main observed problems are : unappropriated or incomplete tests, underestimating of some of the automated functions, lack or lost of production data managed by the machine control system.
Bepm Automation, thanks to its experience in the computerized systems for medical devices assembly machines, can assist you for the la validation of the control system, especially for:
Writing and/or review of user requirement specification (URS)
Review of functional and design specification provided by the machine builder
Functional risk assessment
Review and/or execution of the tests