Ashar Samdani: CEO of Code District, a Washington-based software development firm that focuses on helping businesses incorporate modern tech
“You are only as strong as your weakest link.” I cannot think of a better proverb when it comes to surviving in an industry as regulated and as nerve-wracking as pharmaceuticals or life sciences.
One cannot afford to slack even the slightest bit or have one department or inattentive person on your team. That is why I have immense respect for people working in all the verticals of the healthcare industry; not only is their job demanding, but the impact they have on our lives is immeasurable.
The Quest For Cost-Effective Pharmaceutical Solutions
In my work with leaders in pharmaceuticals, I’ve found they are always on the lookout for advanced solutions to make drugs cheaper and more accessible. That’s why, when computer system validation (CSV) technology was first introduced in the ’70s and ’80s, many recognized its potential to streamline and accelerate good practice (GxP) validation processes.
Today, computer system validation is a crucial component in pharmaceutical manufacturing. Even though CSV technology has come a long way, its core purpose remains the same: “Ensure that each software component involved in the process can perform in a manner consistent with set guidelines laid down by the FDA.”
The Need To Develop Better CSV Solutions
Pretty much everyone in the industry can attest to the need to engineer better and faster CSV solutions. With stringent FDA regulations and increasing competition, manufacturers are fighting many battles at all the different junctures. I find that traditional CSV workflows often face errors and delays due to manual processes, fragmented documentation and system integration issues.
Thankfully, there is a new way that promises to make CSV solutions cheaper, more efficient and more reliable. Yes, I am talking about DevOps, and I am certain that most of you have probably heard of it. That is likely because either you or your pharma manufacturing peers are already leveraging this approach. In fact, according to Help Net Security, 73% of healthcare professionals globally are deploying DevOps.
DevOps And CSV In Pharmaceutical Operations
According to the IBM Systems Science Institute, fixing bugs product’s release is four to five times more than addressing them during the design phase.
I think this highlights the value of integrating DevOps with CSV. Moreover, I think it is becoming crucial to utilize this integration to help ensure software releases comply with FDA regulations. Here are some other areas to take advantage of when looking to integrate DevOps with CSV:
Accelerating GxP Validation And Audit Readiness
DevOps can help speed development by embedding continuous validation into the CI/CD pipeline, ensuring compliance checks happen in real time without disrupting workflows. Moreover, a CSV framework can help ensure version control, audit trails and electronic record validation, simplifying FDA and other regulatory audits.
Cost-Effective CSV Management
DevOps is great for breaking down development into short sprints, minimizing the risk of errors. As Daffodil outlines, “testing occurs at the end of each sprint to discover bugs and architectural flaws and respond by improving the code more quickly.” I’ve seen how this approach can significantly help avoid the financial and time costs of fixing issues post-launch.
Enhanced Test Automation
DevOps emphasizes the automation of build, deployment and testing processes. Automated and AI-powered testing has the potential to revolutionize quality assurance and CSV approaches. Overall, automated regression testing allows for more frequent updates without sacrificing stability.
Implementing DevOps For CSV In Pharmaceuticals
To integrate DevOps into CSV, I think it’s important for companies to take a phased approach and ensure compliance integrity throughout the process.
1. Align cross-functional teams. IT, QA, and compliance teams must collaborate from the start to ensure validation processes meet FDA and GxP standards.
2. Adopt gradual automation. Begin with CI/CD pipeline integration for validation before expanding automation to critical workflows.
3. Leverage AI-powered testing. Automated compliance checks and audit trails reduce human error while maintaining regulatory accuracy.
4. Enable continuous monitoring. Implement real-time compliance tracking with version control and automated logs for audit readiness.
5. Foster a compliance-first culture. Training programs can help teams adapt to automation-driven validation while retaining essential manual oversight.
When To Apply DevOps
DevOps is especially ideal for implementing CSV in uncertain production environments where user requirements can vary over time.
Key concerns when incorporating this system include data integrity, audit trails and real-time compliance tracking. Therefore, it’s important to focus on version control, AI-driven testing and automated documentation when utilizing CSV to maintain accuracy and reduce human error. Make sure you focus on being inspection-ready for FDA, GxP, and 21 CFR Part 11 requirements.
Impact On Overall Operations
Cost savings from efficient CSV management can be reinvested in research and development. On top of this, improved audit readiness ensures continuous compliance, helping protect your company’s reputation and avoid costly penalties.
In conclusion, I think DevOps and CSV form a powerful duo that, with strategic implementation, promises to propel the pharmaceutical industry to new heights and deliver significant value across the entire pharmaceutical value chain.
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