For Regulatory Compliance, Automation Matters
For labs operating in highly regulated industries, ensuring compliance is essential. That can involve meeting specific standards, demonstrating reproducibility, and tracking all data for an audit trail. Failing to comply with these requirements can mean product delays, hefty fines, and severe damage to a company’s reputation.
Automation can help scientists avoid these problems by enabling them to run experiments while meeting regulatory compliance criteria. Here’s a look at a few key areas where implementing automation really makes a difference.
Standardizing processes across labs
To meet compliance requirements, scientists need to use the same experimental processes and protocols over and over. This is especially important for pharmaceutical companies where multiple labs might be responsible for making the same products. Besides ensuring that all the company’s labs run the same protocols, standardizing processes through automation can help scientists manage many of the complexities of running experiments in different labs.
Automating manual operations
Automation reduces the risk of compliance failure by providing better process control and management. In cases where labs run afoul of the regulations, sometimes the problem can be traced back to simple human error. While some lab processes may always require human intervention, scientists can improve compliance by automating many tasks, such as dispensing samples and moving plates. They can also implement integrated workstations accessible through a single interface where scientists can schedule and launch experiments using validated protocols. Automation allows for customized user permissions to ensure that only authorized individuals can make changes.
Better data and information capture
With automation, labs can capture data throughout their processes. This makes it easier to identify problems and trace the sources of error. Automated solutions also seamlessly transfer data from instruments to centralized information management systems where it can be reviewed by key decision-makers. Compliance officers in the lab can easily pull data they need to meet transparency and auditing requirements for regulatory submissions.
At Biosero, our team is committed to helping our customers accomplish their business goals. Our Green Button Go® Scheduler with the 21CFR11 Manager extension meets requirements for 21 CFR Part 11 compliance set by the US Food and Drug Administration for highly regulated labs. Reach out to learn more about how we can help.