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In our previous blog, we discussed the steps to develop a plan to move to Computer System Assurance (CSA). In this blog we consider the key methodologies and technologies, along with other important considerations to transition to CSA.

There are several important factors to consider to ensure a successful transition to CSA. They are focused on those areas that can provide a major impact to your CSA implementation.

It is essential that the EQMS is not siloed. Quality information should be collected as data and leveraged across the organization to make informed decisions.

The EQMS has to also have an interface to other systems whether it is ERP, PLM,  supplier quality, vendor management, or other enterprise systems integral to the organization. Those interfaces are critical because that is where data resides, and access to that data is vital for decision making.

EQMS also needs to be mobile. It can’t be at one particular location or region or within one area. The EQMS has to provide the ability to look at data wherever, whenever, and however needed. Having this visibility to the pertinent data allows teams to make decisions faster as well as implement controls that prevent issues and non-conformances further in the processes.

Conclusion

As we’ve outlined, there are multiple methodologies and technologies to consider when the organization is looking to transition to CSA. By leveraging the right mix of tools and methodologies, the organization’s move to CSA will result in lower risks during the transition.

Additionally, it is equally important to have the right skill sets (internal and external) to assist with implementing these approaches and tools.  Knowing the various methods and technology and being able to apply them are effectively two distinct requirements.

Why it Matters to You

Organizations making the transition from Computer System Validation (CSV) to Computer Systems Assurance (CSA) will benefit from this information in the following ways. It will:

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation & dedicated staffing services for science-based businesses.  Through our proven laboratory informatics, digital quality & compliance, and scientific staffing services we deliver the highly specialized people, processes, and technology to fundamentally transform how science-based businesses operate.  Astrix was founded by scientists to solve the unique challenges which science-based businesses face in the laboratory and beyond.  We’re dedicated to helping our clients speed & improve scientific outcomes to help people everywhere.