Biotech and pharmaceutical companies are required to comply with regulations enforced by the US Food and Drug Administration (FDA). Among these regulations is the Current Good Manufacturing Practice (CGMP) which governs the quality control of not just manufacturing practices and facilities but also the technology components of the drug production process.
Software used in the pharmaceuticals industry must help with the planning, manufacture, and tracking of the stock of goods, maintaining patient records, and management of sales data over the cloud.
Point of Sale (POS), Electronic Signature Capture (ESC), and Enterprise Resource Planning (ERP) are examples of the kinds of software involved. But how do we ensure that these technology components comply with FDA regulations?
What is the need for Computer System Validation (CSV)?
In the pharmaceutical industry, quality control is the most important step in the production process because the smallest failure in compliance could have far-reaching and potentially fatal consequences.
So companies use Computer System Validation (CSV) to ensure that each software component involved in the process can perform in a manner consistent with set guidelines laid down by the FDA.
The Software Development Life Cycle (SDLC) of CSV software traditionally operated in the waterfall model. In this model, the testing takes place at the end of the software product's release but leads to high costs and a slow delivery speed.
What could DevOps do for pharmaceutical CSV software?
The IBM Systems Science Institute reported that the fixing of bugs after the release of a product is 4-5 times more expensive than getting them fixed during design.
With DevOps-integrated CSV, you can ensure that pharma software complies with FDA regulations and can integrate with the required SDLC tools seamlessly. The DevOps methodology integrates all the software development functions from development to operations within the same cycle.
This integration lets you judiciously utilize your technology investment and improve efficiency. Beyond the scope of compliance, DevOps could help set up a validation framework to help the business move quickly and release builds and updates more often.
Specific ways in which DevOps optimizes CSV are:
Faster GxP Validation Operations
GxP is the acronym that encompasses a series of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP) that a life sciences organization must implement.
A CSV ensures that software passes these compliances and DevOps is integral to making this process faster and reproducible. DevOps can help in cutting down on internal GxP approval processes for pharma software by creating a Continuous Integration/Continuous Delivery (CI/CD) pipeline.
This pipeline helps with regular monitoring to keep a track of whether ongoing work on software meets GxP goals without having to halt the development cycle at any point. By embedding verification and validation into the SDLC, it is easier to automate workflows so that the software gets to the go-live stage faster.
Cheaper CSV with DevOps Project Management
The FDA has realized that a strict focus on compliance rather than the quality of the technology components may divert a large chunk of the pharmaceutical organization's resources and funding towards the former.
The regulatory authority has therefore embraced the implementation of DevOps project management strategies in expediting CSV and also cutting down costs involved.
By breaking down the pharmacy software's development into short sprints, DevOps can effectively reduce the overall risk of introducing errors at the end of a lengthy development process.
If these errors were to remain undetected till the software's launch, it would be costly in terms of time and capital investment to resolve them. With the DevOps model, testing occurs at the end of each sprint to discover bugs and architectural flaws and respond by improving the code more quickly.
Test Automation to Achieve Regulatory Goals
DevOps lays great emphasis on the automation of build, deployment as well as testing. Test automation and AI-powered testing can assist pharmaceutical companies to enhance their quality assurance, incrementally evolving their CSV approach.
By automating software tests to verify compliance, the frequency of software testing at each SDLC stage increases. Automated regression testing, where data files are reprocessed and the result is compared with the previous result, is a strong testing method for CSV.
Based on these tests, the CSV assigns Performance Qualification (PQ) to software, which boosts an organization's ability to regularly update it. This helps reduce damage to its reliability or stability, vastly reducing costs on improving CSV software.
Improving Audit Readiness
DevOps helps life sciences organizations stay ready for surprise FDA audits of both pharmacy software and the CSV software by automating manual regulatory compliance processes.
This helps the CSV framework maintain a regular check on record versions and audit history, while itself serving as a reliable system of keeping records. It also verifies the validity of electronic records, electronic signatures, bills, and documents beforehand, so that the audit process is seamless.
When to Apply DevOps?
An iterative approach such as DevOps is most suitable for implementing CSV with optimum results, especially in situations of great uncertainty. This uncertainty can manifest itself in a production environment where the user requirements for pharmaceutical software are not well-defined from the start. Traditional project management practices do not address this issue quite as well as DevOps.
If the primary focus of your POS or ERP software is user engagement and satisfaction, DevOps facilitates transparency and proper collaboration in CSV. The resultant software is then compliant with FDA regulations and frameworks, while at the same time top quality and free from end-of-the-line bugs and architectural flaws.
Implementing DevOps in Pharma CSV
Both CSV and DevOps have the same end goal when it comes to software development; improve the delivery quality for end-users, while adhering to regulatory guidelines. You can keep your risks in check and provide better visibility for planning your communications or escalations with every stakeholder in the software development process.
Usually, pharmaceutical companies have long software development timelines, which raises issues around resource allocation and planning for each update or bug resolution. If you wish to leverage DevOps in optimizing CSV, you can get in touch with our DevOps experts through our consultation form and our team will get back to you.