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Automated System Validation

 

 

Automated System Validation

Automated system validation must be carried out for manufacturing processes to be flawless and a success. Validation of an automated system helps ensure compliance, demonstrate system control, and establish future requirements. ADB is knowledgeable on the essence of the validation of automated systems and has an engineering team with extensive experience and skills.

 

Automated systems that require comprehensive testing and validation include Programmable logic controller (PLC), controllers, computerized systems, and Distributed Control System (DCS). ADB’s validation policy complies with the applicable regulatory requirements. After our engineers ascertain the scope of the project at hand, you can be assured of satisfactory validation services including:

  • Validation master plan
  • User/ functional function specification
  • Risk assessment
  • System verification ( IQ, OQ, and PQ) and documentation
  • Change control management
  • User training
  • System testing
  • Validation report

A professional and well-structured validation process can help enhance the performance of automated systems. There are benefits for having your systems validated as validation can help:

  • Reduce the time to attain a compliant system without overrunning the budgeted cost
  • Provide appropriate change control management
  • Reduce the time of likelihood projects ‘going-live’
  • Enhance product and system quality, traceability and safety
  • Ensure regulatory compliance
  • Help meet clients’ immediate and long-term needs
  • Enable knowledge transfer to help support and maintain a validated state system

ADB has sufficient resources to carry out validation projects and also make use of a collaborative team approach. Our validation engineers have management are renowned for their commitment management and competent project management. Other services that our team can offer include:

  • Use of custom designed dynamic approach to integrate ingenuity, integrity, creativity and objectivity to coincide with user specification
  • Validation plan design, execution, evaluation and approval
  • Developing problem resolution
  • Training plans preparation, execution, evaluation and approval
  • Documentation of completed validation
  • Data migration verification
  • Required materials identification and provision

 

 

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Testimonial / What Our Client Say

Andre and his team were professional, focused and sensitive to the timing issues associated with my project. Most importantly, after the project completed Andre and his team did not disappear. As I needed answers and follow up information, his team followed up in a timely and accurate manner. I look forward to using the services again and would recommend them highly.

Erik Emerson, President & CEO at Symplmed



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