The Montana Bioscience Alliance, founded in 2004, is almost 20 years old. It came from a study identifying life sciences and pharmaceuticals as a potential growth industry in Montana. One of the Alliance’s findings was that the entities in Montana that made up the industry needed to be better networked. Companies would seek partners in other states before turning locally for many of the products and services they needed. Thanks to the Alliance, things have gotten better.
FICO, based in Great Falls, Montana, plays an essential role for these Montana-based companies by providing systems and services that help to meet compliance with Title 21 CFR Part 11 of the US code. This is the FDA regulation defining the requirements for electronic validation for companies involved in life science–including pharmaceutical, biotech, and medical devices.
What’s inside this blog post:
- What is Title 21 CFR Part 11, and how is FICO involved?
- How seriously does the FDA take these pharmaceutical regulations?
- Where does BAS fit into Title 21 CFR Part 11?
- The importance of bringing in experts.
What is Title 21 CFR Part 11, and how is FICO involved?
Let’s turn that question around.
FICO designs, installs, and services building automation systems (BAS) in office buildings, hospitals, schools, universities, and other business entities. These systems are also often called building management systems (BMS). Building automation systems control and optimize HVAC, electrical systems, building access, security, and other operations that, when choreographed, allow for optimum function and comfort for building occupants, also saving money and energy.
BAS systems can also meet the needs of bioscience companies, specifically pharmaceutical manufacturers. The manufacturing processes for these companies have strict guidelines for temperature, humidity, and air pressure in their critical manufacturing zone. FDA’s Title 21 CFR Part 11 specifies how pharmaceutical companies must electronically document and validate their environments and other aspects of their manufacturing processes.
Schneider Electric, a partner company of FICO, developed Compliance Pak, a software package that combines environmental controls with electronic validation, allowing pharmaceutical companies to meet the requirements of Title 21 CFR Part 11. This is the system that FICO uses when working with bioscience and pharmaceutical companies.
“Adhering to FDA regulations is important,” says Mitch Andrus, an account executive at FICO, “and guaranteeing the integrity of that data is important, but there is a secondary benefit. These systems are also a vital part of quality control. Monitoring the electronic data capture means improved product quality and less waste from batches that fall out of tolerance. So not only do these systems verify compliance, but they minimize risk and improve the financial bottom line.”
How seriously does the FDA take these regulations?
Glenn Chin, a supervising pharmacist for New England Compounding Center, received a sentence of eight years in prison and two years of supervised release. According to the FDA Office of Criminal Investigations, Chinn ignored drug formulation worksheets, conducted improper sterilization processes, failed to verify processes, and conducted improper testing, along with numerous other violations. The tainted drugs caused almost 800 cases of fungal meningitis, of which 64 were fatal.
Chinn’s case is egregious, but it illustrates the importance of audit trail requirements and regulatory compliance with Title 21 CFR Part 11 and how seriously the FDA takes them.
Where does BAS fit into Title 21 CFR Part 11?
The previously mentioned Compliance Pak is used in unison with EcoStruxure Building Operation software, also from Schneider Electric. The EcoStruxure system regulates building temperature and humidity. Together, the two systems help companies meet their electronic validation requirements. Features include:
- Restricted access to authorized individuals
- Electronic time stamping of notations (time of day and day of week)
- Operator location
- Complete system scheduling
- Maintenance of a complete archive of all system events
- Electronic signature and audit trails
- Long-term archiving
While the ExoStructure Building Operation software and the Compliance Pak are standalone systems, they are often part of a larger BAS system that governs building HVAC, electrical distribution, access control, and security. These are critical functions for a bioscience or pharmaceutical company.
FICO brings expertise in system implementation
FICO engineers and designers work with bioscience and pharmaceutical companies to determine how to design their facilities properly. Offices, warehousing, and other parts of the operation require an effective BAS to operate efficiently and provide a comfortable environment for employees. They don’t demand the same level of monitoring as those areas involved in manufacturing and production, though. FICO helps companies determine these critical zones and recommends the most appropriate BAS system. These systems might involve physically separated networks, combined systems on the same network, or customized solutions.
“There is a good deal of specialized knowledge for compliance with Title 21 CFR Part 11,” said Mitch Andrus. “Additionally, technological changes and new research are always happening in bioscience and pharmaceuticals. Nothing is static. FICO’s BAS systems operate on open networks, meaning updating a system with new data and verifying it is typically a seamless process.”
“Most of the pharmaceutical companies we work with are national and international companies with a part of their operations in Montana,” he added. “Much of our work is in Montana, but FICO can work anywhere in the US.”
Andrus also added that FICO regularly works with third-party commissioning engineers and experts to ensure that the system meets all the requirements of FDA guidelines.
