System Validation

Ensuring FDA Compliance

 

Compliance Through Validation

To pass FDA, customer, and internal audits, manufacturers subject to GMP and GAMP must be able to provide a complete documentation package verifying compliance. ACE leverages our quality system and yours and follows the process validation lifecycle to develop your requirement and design documentation and to generate and execute test scripts for the installation and operational qualification. Whether these validation services include a workshop on validating an automation system or development of a complete documentation package, ACE can take the lead or support the efforts of others.

 

Technology Partners

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Broad Expertise and Proven Solutions

Faster Commissioning Through Leveraged FAT

When installing or making changes to a validated system, each function must be tested. You may have a substantial amount of downtime testing each function if the tests are performed on the actual process system. ACE executes a factory acceptance test (FAT) at our office outside of a production environment, so that the system can be proven to meet your expectations. This approach limits deviations when the system is validated onsite, resulting in a faster commissioning, and a reduction in the amount of retesting.

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Easing Your Validation Through Best Programming Practices

The programming practices have an impact on how hard or easy it is to validate a system. Without a partner who is well versed in best programming practices, such as modularity, the development of documentation and execution of testing may be more complex than necessary. Our engineers follow our ISO 9001- based quality system to ensure that code modularity, re-use, testing, and documentation are all consistently done according to GxP guidelines.


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PLC, HMI, SCADA

Project Examples

 

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