Computer Software Assurance (CSA) is a new guideline that is set to take over manufacturing, operations, and quality system software. That is meant to allow manufacturers to minimize the existing computer system validation (CSV).
The release of the proposed CSA model is set to take place late this year. It focuses on key elements such as critical thinking, patient and product safety, documentation, data integrity, quality assurance, risk analysis, and automated testing.
It aims to ensure quality systems software on manufacturing an in operation. They are all connected to provide services that are easier and more updated that the existing Computer Software Validation.
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Comparison between CSV and CSA
The move to CSA aims to eliminate monotony in documentation to enhance compliance. It will also ensure that risk-based assurance in applying the required level of risk to product and patient safety is put into consideration.
With the existing CSV, there is a tendency to ignore previous assurance activity, and other risk controls areas; thereby, a decrease in functionality is present. However, with the new CSA guidelines, this is bound to change.
Considerations in Transitioning;
Needs assessment
Piloting of the CSA movement will require business providers to perform an assessment;-
- It will be geared to ensure a successful implementation of the paradigm shift into the new computer software assurance.
- To evaluate the current CSV process for blind spots and long-term improvements.
- Based on the uniqueness of a business model, it will prioritize the recommended changes necessary.
- It improves the vendor qualification process.
- It enables an effective tailor-made shift geared towards building a CSA roadmap.
Training
It involves allowing the team to come into familiarization with the system to enhance productivity.
- The team is conversant with the existing computer software validation loopholes and why the transition is essential.
- To increase awareness and knowledge about the CSA principles and benefits.
- Impact of the CSA on the business.
- Anticipating any challenges
Develop a CSA plan
The plan has to ensure that the critical elements proposed in the model are taken into consideration;-
- Risk determination – critical thinking plays a significant role in providing quality and safety. High key risk areas need more rigorous assurance in terms of input and evidence validation effort to support it. That, therefore, ensures functions and operations run smoothly and perform as intended.
- Testing activities- whether scripted or unscripted, it will be appropriate to test the methodology that will be employed.
- Assurance – That the results seeking to be achieved are met. Features as functionality, quality, and data integrity are present.
Benefits of a CSA approach.
As businesses transition into the new model, they are assured of the following,
- Capability to deliver value on the set things.
- Improve efficiency and quality.
- A decrease in up to 90% in test script studies
- Less time incurred in testing.
- Cost-effectiveness in the validation cost of up to 50%
ConclusionÂ
Implementation of the new CSA guidelines will see to it that the path of automation is considered and geared toward the effective patient and product safety.
