Massimo Crudeli
Pharmaceutical companies, biotech firms, and other life sciences organizations are all too familiar with the term Computer System Validation (CSV). It’s an important regulatory requirement that helps ensure product quality and patient safety.
As businesses in the life sciences sector increasingly go digital and eliminate paper-based processes, adhering to CSV requirements set forth by the U.S. Food and Drug Administration (FDA) is an absolute imperative.
Great emphasis is placed on documentation to satisfy auditors—a time-consuming, costly task that ironically inhibits the adoption of technological innovations that have been proven to increase quality and safety. Life sciences companies that want to reduce errors, automate processes, and optimize human resources through technology have demanded—and deserve—greater clarity on the FDA’s expectations for software validation and a more agile process to support CSV.
To fulfill this need, the FDA has been providing guidance for an easier approach to validation known as Computer Software Assurance (CSA).
CSA is “a risk-based approach for establishing and maintaining confidence that software is fit for its intended use,” according to an FDA guidance report called Computer Software Assurance for Production and Quality System Software.
Using this approach, life sciences companies can prioritize risk and eliminate the need for documenting test activities that pose little risk to critical outcomes.
The CSA method involves the following steps:
- Identify the intended use of all system features
- Determine the relative risk of each feature: 'High-process risk' applications require full testing and documentation, while 'not high-process risk' applications can undergo a streamlined validation process.
- Apply the appropriate validation activities: Traditional Scripted Testing is used for high-process risk applications, while Unscripted Testing activities, such as ad-hoc testing, error-guessing, and exploratory testing, are used for applications that are not high-process risk.
- Establish appropriate records: While the FDA requires evidence that proper testing steps have been performed and that software features work as intended, the documentation burden is significantly less using the CSA approach.
How Can STAEDEAN Lower the Validation Effort?
The CSA approach led to a new role for suppliers, who began contributing to the strategic and targeted reduction of the validation effort. It is indeed true that life sciences organizations can and should leverage documentation provided by their suppliers as an assurance activity. Supplier evaluations help determine the risk associated with each supplier and their associated software.
To meet its requirements for features related to life sciences enterprise resource planning (ERP), STAEDEAN conducts ongoing internal testing and makes all documentation available to its customers.
The validated state of the STAEDEAN Life Sciences solution is derived from adhering to an ISO 9001:2015 certified System Development Lifecycle that reflects the CSA approach. By focusing on the critical thinking needed to manage risks during all phases—design, development, testing, build generation, build release, and maintenance—STAEDEAN provides the right level of assurance and documentation to satisfy FDA requirements.
To explore how the STAEDEAN Life Sciences Validation Toolkit can help you validate your ERP
Massimo Crudeli