CSV Initial Assessment

Computerized systems used in the development, manufacturing and throughout the lifecycle of biopharmaceutical products and medical devices need to be validated for GxP and other purposes.

This is a complex procedure that is carried out in identifiable phases, described by C-realize in its blog pages (see Resources). The first of these steps is Initial Assessment, the foundation on which the success of the whole project rests.

System Level Impact Assessment

Initial Assessment itself consists of different phases, of which the first is assessing system-level impacts: understanding if and why the system in question needs to be validated and to what extent. The need for validation will depend on the system’s intended use, rather than its type. For example, a system used in preclinical research and development should be validated to meet good laboratory practice (GLP) standards. The same system used in commercial production would need to be validated to meet Good Manufacturing Practice (GMP) guidelines, which are stricter and require more effort.

The exercise will also determine if other regulations (e.g. SOX, HIPAA, GDPR) are applicable and need to be considered within the project.

For complex systems, a component-level impact assessment can sometimes help to further distinguish high-impact components within the system that must be validated from the outset, as opposed to lower-impact aspects that can be part of a later ‘fine tuning‘ process.

System Complexity

Another factor determining the extent of validation is the complexity of the computerized system. While there are no precise guidelines here, the GAMP® forms a useful guide recognized by industry and regulatory authorities.

It involves defining different categories each of which involves progressively higher levels of adaptation, configuration, customization, that bring with them ever higher levels of complexity, uncertainty, and therefore risk. These risk factors should be reflected in the level of detail in system design documentation and in the amount of testing required.

Defining The Electronic Record(s)

After assessing the system, the focus shifts to the data. For this exercise, companies often refer to the FDA’s 21 CFR Part 11 regulations. These cover “…records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations…” and “…electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations”.

Supplier Assessment

Also known as Vendor Qualification, the Supplier Assessment determines the choice of whose products or services will form the basis of the validated.

Supplier Assessment usually involves a balancing exercise, weighing up each company’s size, reputation, product functionalities offered and supported.

The evaluation should reflect the impact and risks of using the system. The criteria for determination of the audit type should be clearly defined in a supplier assessment SOP.

With the current pace of technological innovation, it also becomes more convenient for life science companies to outsource IT services and solutions to focus on their core businesses e.g. Software as a Service (SaaS). However, the greater the dependence on an outsourced supplier, the higher the stakes become in the Supplier Assessment to mitigate risks of the vendor failing to meet the quality and compliance standards demanded. The level of supplier audit should also be consistent with the complexity and criticality of the system to be validated and not the size of the supplier.

Conclusions

Many of the issues arising within a CSV project can be traced back to Initial Assessment. Often, some key stakeholders, especially Quality and Compliance professionals, are excluded from the planning of the project resulting in an inaccurate initial impact and scope determination. These issues usually arise later in the project and can slow down or block progress even more until everything is clarified for everyone and all documentation revised.

Resources

Click on Fundamentals of Computerized Systems Validation (CSV) Initial Assessments: Part 1 to read original blog article.
Click on Fundamentals of Computerized Systems Validation (CSV) Initial Assessments: Part 2 to learn more.

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