Today’s life sciences landscape is saturated with regulatory scrutiny. From price reporting to patient privacy to quality controls, pharma and biotech compliance teams have their hands full these days. But even as companies struggle to keep up with ever-changing industry standards, their IT departments are under tremendous pressure to ramp up digital innovation.
As more and more life sciences firms implement Salesforce and other low-code cloud platforms to accelerate their go-to-market strategies, they encounter a tricky challenge: How do you accelerate digital transformation in a compliant way? In other words — can you scale your DevOps capabilities and ensure GxP compliance with FDA 21 CFR Part 11 at the same time?
What is GxP and FDA 21 CFR Part 11?
In the life sciences industry, GxP is short for “good practice” quality guidelines and regulations. GxP guidelines are regulated by the Food and Drug Administration (FDA) and focus on traceability, accountability and data integrity. Pharmaceutical and biopharmaceutical companies follow them to make sure products are safe, meet their intended use and adhere to quality processes during manufacturing, storage and distribution.
FDA 21 CFR Part 11 compliance enables regulated industries to use e-signatures and other electronic records. It means these digital documents are just as official as paper records and handwritten signatures. By moving to a digital footprint, life sciences organizations can better track their compliance and ensure safe products for their consumers.
Maintain Compliance Across the Software Development Lifecycle
As more pharmaceutical and biotech companies turn to low-code cloud platforms like Salesforce and Veeva, they often struggle to scale their app development in a compliant way. Traditionally, life sciences organizations wait until release day to validate compliance. But a last-minute approach gives you zero visibility. If there’s an issue, teams have no idea who or what caused it. This can lead to sensitive data leaks and release delays.
Copado’s low-code DevOps Platform makes it easy for development teams to maintain compliance across the entire end-to-end development pipeline without compromising quality and speed. Bring no-code, low-code and pro-code teams together to plan, build, test, deploy and monitor software across multi-cloud environments.
Five Ways Copado Ensures 21 CFR Part 11 Compliance
From idea to feature release, having visibility over every step in the software development cycle helps you maintain compliance and improve processes. One key indicator that Life Sciences organizations are lacking visibility into their lifecycle: An over-reliance on manual processes that take a ton of time and are often error-prone.
Another sign you lack visibility is a lack of understanding between teams and how their work fits into the big picture. When developers prioritize work without tying it back to the main project, it can lead to merge conflicts, feature release delays or (shudder) unused features.
With Copado, you can organize your plans, ideas and work requests and tie all activities to a user story. This makes cross-team collaboration easy and fast. You can also integrate existing application lifecycle management (ALM) and DevOps platforms to provide end-to-end visibility when user story changes automatically update JIRA, Azure and more.
Automated Traceability & Accessibility
To ensure 21 CFR Part 11 compliance, every change made to an electronic record must be tracked. Records should show the who, what, and when behind every change. In addition, life sciences organizations need to authorize who can access data, who can change it and who can sign off on electronic records.
Copado helps you understand exactly how your systems change over time. With 100% traceability on user stories, Copado tracks all changes in Salesforce — allowing for easy and automated traceability and reporting. Control who can commit, promote and deploy between environments with ease.
Documentation Sign-offs and Audit Trails
Your lifecycle may include multiple sign-offs that must occur to keep your application development moving forward. These sign-offs need to be time-stamped and tracked for audit trails to help organizations enforce process changes and ensure compliance. This used to be a paper-based process — but with FDA 21 CFR Part 11, digital signatures and tracking are required.
As a cloud-native application, Copado inherits Salesforce’s ability to set up an audit trail and provide electronic signatures. Life sciences organizations can easily view login info and activity history of all users. This data can be integrated with security information and event management (SIEM) and printed as necessary.
You can’t guarantee that every release will meet compliance and quality requirements if you don’t execute testing and enforce guidelines early and often in the development cycle.
As DevOps teams begin to scale, Life Sciences organizations often have a difficult time enforcing consistent compliance controls across the dev cycle – leading to costly and time-consuming fixes on release day.
With Copado, you can easily scale compliance controls across teams. Setup simple configurable rules to manage your requirements without coding. Schedule compliance scans at any stage to build quality gates into every release and monitor all compliance violations and systems in one location — in real-time.
Reduce Cost with Testing
Defects found later in the release cycle are 640X more costly to resolve than those found during an earlier stage. As regulatory requirements shift and release times get shorter and shorter, life sciences organizations need to keep up with rapid-feature development without risking quality in order to stay competitive.
Reduce reliance on manual test scripts and future-proof your dev cycle with Copado Robotic Testing. Easily set up test automation with our no-code Salesforce Recorder. Embed testing within DevOps to build feedback for quality releases. Confidently test end-to-end processes across platforms, orgs and executions with cloneable robots.
Accelerate Low-Code SaaS Delivery Without Compromising Compliance or Quality
The people who build your applications drive your business. The low-code DevOps revolution is underway — 70% of new applications developed by enterprises will use low-code or no-code technologies by 2025. As low-code development teams grow in size, business challenges begin to arise.
Don’t let compliance slow down your software development process. With more opportunities to automate and scale low-code SaaS applications, Copado can help you unleash the power of your low-code SaaS applications.