Smart cameras have become a go-to solution for many industries looking to streamline visual quality control. They’re compact, easy to set up, and relatively inexpensive. But when it comes to using them in the medical industry, particularly in regulated environments like pharmaceutical or medical device manufacturing, the equation changes significantly.
At JLI, we’ve worked with a number of companies in this space who started with off-the-shelf smart cameras, only to find that the “quick and simple” approach came with compliance headaches and costly limitations. If you're considering smart cameras in a validated production environment, here are the key issues you need to be aware of, and how we can help navigate them.
1. Audit trail
One of the most basic yet critical requirements in regulated environments is the presence of a secure and readable audit trail. Unfortunately, most commercial smart cameras do not provide audit trails that meet compliance standards.
Even if logs exist, they may not be human-readable or protected from tampering, which makes them unsuitable for environments where traceability and documentation are essential. This lack of audit integrity can jeopardize your entire validation process.
At JLI, we can equip your smart camera setup with a custom-built audit trail system that stores logs in a readable format, ensures they’re tamper-proof, and meets the traceability requirements outlined in GAMP and FDA guidelines.
2. Version control
Proper version control is often overlooked in smart camera implementations. Configuration files tend to be a mix of setup parameters and logic, which makes it difficult to maintain a clear baseline or track changes over time.
This becomes a real issue in medical applications, where any change to the vision system must be documented and reproducible. Without robust version control, you risk failing audits or losing track of which configuration was in use for a specific batch.
JLI addresses this by adding tools that separate and manage different configuration elements, enforce version control practices, and enable clear baselining of the system, making it possible to maintain the vision system with confidence.
3. Password and user management
Medical environments often require strict user access controls and password policies. Strong passwords, limited access, session timeouts, and role-based permissions. However, many smart cameras offer little more than a basic login screen.
Worse, in some cases, users can exit the vision application and access the underlying operating system, introducing serious compliance and cybersecurity risks. JLI can customize your smart camera environment to enforce your organization’s password policies, restrict user access appropriately, and lock down the system to prevent unauthorized interaction with the underlying OS.
This ensures the device remains compliant with IT and regulatory standards.
4. Logging of data and image storage
Data logging and image storage are essential for traceability and batch documentation, but native support for these features is often missing or insufficient in smart cameras. If the system cannot reliably store inspection results and associated images, or if it stores them in unsecured or inaccessible locations, you could be exposed to data integrity issues or lose key documentation needed for audits.
JLI solves this by implementing custom solutions that log relevant data and store inspection images securely on your network. These data stores can be integrated into your batch reporting systems, ensuring full traceability and compliance.
5. Performance monitoring and diagnostics
Even a well-calibrated system can fail if it overheats, loses a network connection, or suffers a hardware fault. Yet many smart cameras offer little or no built-in diagnostics or performance monitoring.
JLI adds a diagnostics layer to the smart camera system that continuously monitors health metrics like temperature, hardware status, and connection integrity. We also set up alerts for critical failures, so issues can be addressed in due time.
6. Network compatibility and security
Smart cameras must operate within secure network environments, but most are not designed with IT compatibility in mind. They may lack support for virus scanning, firewall rules, and whitelisting protocols.
IT departments are increasingly unwilling to allow such unprotected devices on internal networks. While some companies try to isolate smart cameras on their own subnets, this often proves impractical.
At JLI, we work closely with your IT department to ensure the smart camera can function within your network security framework. If needed, we create secure network configurations or encapsulate the camera within a protection layer that satisfies IT and compliance standards.
7. Operating system maintenance and patching
Some smart cameras run on embedded versions of Windows, but do not support regular patching or system updates. This can lead to security vulnerabilities and disqualify the system from being used in a regulated environment.
Without a strategy for maintaining the OS, your system may quickly become non-compliant. JLI has deep experience managing smart camera platforms over time, including deploying update mechanisms and long-term maintenance strategies that align with medical industry requirements. This ensures your vision system remains secure, functional, and compliant well after installation.
When to use smart cameras—and when not to
Smart cameras can be a practical and efficient solution in many applications, and sometimes also within the medical industry, but only if the necessary layers of functionality are added to meet compliance standards. In some cases, we can retrofit these features. In more complex environments, the better long-term approach will be to implement a custom-built vision system designed for regulatory compliance.
Whichever path you choose, one thing is clear: smart camera vision systems in medical environments require more than plug-and-play installation. At JLI, we help you assess feasibility early, involve your IT and quality teams, and implement the right level of control to make sure your solution doesn’t just work, but works within the rules.
