Secure Files for GMP Compliance: The Need to Manage Isolated Data from Equipment Skids, Instruments, and HMIs
The Problem: When Isolated Data Needs to be Brought into Compliance
Manufacturing equipment produces huge amounts of data each day. In many cases, for newer equipment, data collection is built into the product, and the data produced by the equipment is simple to access. It’s no huge obstacle for engineers to report on the data for quality and compliance purposes. But for legacy equipment and islands of automation, the path to accessing the data may be less clear.
Many manufacturing systems, such as equipment skids, instruments, and HMIs, generate files that can cause data integrity vulnerabilities if not handled appropriately. Oftentimes, this data is in the form of CSV, XML, SQLite, and JSON files. These files can contain valuable operational information that cannot be effectively utilized without additional processing. For example, Rockwell HMIs produce audit trails of user actions, but without a way to access and store these audit trails, the data can fall outside of data integrity compliance guidelines.
It can be prohibitively expensive to replace legacy equipment that produces inaccessible data but that is vital to a manufacturer’s operations. How can manufacturers make the most of the data they have, and most importantly, how can manufacturers ensure that the data they produce is made GMP compliant?
The ETL process provides a solution for the handling of isolated data from equipment skids, instruments, and HMIs. When a manufacturer selects software that uses the ETL process, many of the challenges surrounding accessing this data evaporate.
This blog post will explore what the ETL process is, how it is used in InfoBatch® InfoETL, and how it can be used to make manufacturing data compliant.
What Does “ETL” Mean?
ETL stands for Extract, Transform, Load. Each step of this process is described below. For a briefer overview of ETL, visit this short article.
Access the Isolated Data
The first step of managing isolated data from equipment skids, instruments, and HMIs is to actually access the data. As long as these files remain on the equipment, they not only pose a data integrity issue but also provide no value to the manufacturer. Without a specialized software to acquire the data, accessing the files manually can prove an inefficient and inconsistent process.
The “Extract” step of the ETL process with an ETL-based software like InfoBatch InfoETL allows a manufacturer to easily and dependably extract data from diverse sources.
But once the data is retrieved, what next? It’s not enough to simply access the data. In most cases, these files lack the proper contextualization that would allow manufacturers to get value out of them. The next step of ETL, “Transform,” is essential.
Make Isolated Data Valuable
The “Transform” step of the ETL process allows a manufacturer to transform data contained in files into meaningful information. By using specialized software to access isolated data, the manufacturer is able to seamlessly process and transform it according to specified validation rules. What was once a series of isolated, vulnerable files becomes a useful resource.
Once the data is pulled from isolation and made digestible, it needs somewhere to live so that the manufacturer can access and report on the information. The data can’t be stored on the equipment, where it was a problem before. The last ETL step, “Load,” solves the final piece of the puzzle.
Store Data to Make it Useful & Compliant
The final step of the ETL process is the most important for bringing isolated data into compliance. The “Load” part of the ETL process is used to store transformed data in a secure repository.
At the end of the ETL process, it’s important to ensure the following:
- Security and compliance are prioritized throughout the process
- The original data files are encrypted and stored for future verification, allowing peace of mind for ongoing data validation and audits
- The final, transformed data has been digitized and stored in a manner that supports reporting and integration with other manufacturing and information systems
- The end repository auto-archives to support data retention policies
The Bottom Line
When determining how best to manage isolated data and bring it into compliance, selecting software that uses the ETL process can bring great value to an organization.
InfoBatch InfoETL provides an ETL framework suitable for manufacturing and automation systems. Whereas many ETL solutions are oriented towards cloud-based data warehouses, InfoBatch InfoETL is designed to reside close to the automation infrastructure, immediately processing files without the latency of other approaches. InfoBatch InfoETL and data warehouses are not mutually exclusive. In fact, InfoBatch InfoETL databases can be used to buffer information that is subsequently uploaded to enterprise systems.
Ultimately, it is of vital importance that facilities secure isolated files and bring them into data integrity compliance. By doing so, manufacturers reduce risks on product integrity and release. Manufacturers can protect their processes and their product by gaining an understanding of how to manage isolated data.
For more information on InfoBatch InfoETL, visit the product page or schedule a demo with our team.