Achieving FDA Compliance: Best Practices for Implementing 21 CFR Part 11 on the Niagara Framework

Today’s market is highly regulated and in the automation industry, the stakes are high. A minor malfunction can cause immense losses. This is why regulations are highly crucial for maintaining standards, safety and ensuring smooth functioning with reduced collateral damage. The Food and Drug Administration (FDA) in the United States declare certain regulations to ensure that safety, quality and effective measures are maintained throughout a product lifecycle and the factory and industrial spaces. Among these regulations, the 21 CFR Part 11 pertains to electronic records and signatures. Implementing 21 CFR Part 11 for automation companies like Messung is essential to streamline their compliance procedures. Let’s find out what 21 CFR means.

Compliance with Messung

Messung’s products are built on the Niagara Framework and follow 21 CFR Part 11 compliance. The FDA 21 CFR Part 11 regulations establish the acceptance criteria for the use of electronic records and signatures. Under these stringent guidelines, our products are considered equivalent to convenient paper records and handwritten signatures. Among the many aspects of the FDA compliance, electronic records and signatures, audit trails, alarms and archives come into play. We maintain the highest standards when it comes to data integrity and security. Configurable and customized report formats help us provide safe and secure transactions with our industrial clients.

What is 21 CFR Part 11?

21 CFR Part 11 compliance lists down certain rules for organizations based on research, maintenance and manufacturing. It ensures that the digital records are reliable and trustworthy and are equivalent to the physical records. The regulation is divided into three subparts. 

Subpart A: General Provisions

  1. Digital signature
  2. Electronic record
  3. Electronic signature

Subpart B: Electronic Records

  1. Printed name of signer
  2. Date and time of signature
  3. Review, approval, responsibility, or authorship

Subpart C: Electronic Signatures

21 CFR Part 11 Subpart C mandates that electronic signatures must be unique to individuals and may not be reused by, or reassigned. 21 CFR Part 11 Subpart C compliance urges organizations to protect their electronic signatures with either biometrics or a user ID and password combination.

Leveraging Niagara Framework

The Niagara Framework is a holistic software that elevates the creation of device-to-enterprise applications. Serving as the central core, it connects real-time data to the developers and team that are behind workflow management in building automation, connected enterprises and other industrial setups.

Niagara Framework is an ideal choice to accommodate scalability and flexibility, enabling teams and people to collaborate seamlessly across various locations. Integrating diverse systems within an enterprise becomes much easier. Messung uses Niagara Framework to integrate HVAC, lighting, security and other elements to create smart buildings and automated architectures.

Best practises

21 CFR Part 11 compliance implemented on the Niagara Framework comes with several best practices. So how does Messung ensure impeccable compliance with 21 CFR Part 11 while working on the Niagara Framework?

  1. Risk assessment: 

We validate the current records regularly and flag any points where risks of non-compliance may arise. These areas are prioritized based on their impact on our product’s quality, safety and regulation requirements.

  1. Records availability:

 We validate our systems to ensure our electronic records are up to date and accurate at all times. We also check for any unauthorized access and changes. We are on our toes and keep complete documentation of records readily available throughout the record retention period.

  1. Security: 

We ensure that passwords are secure and no two individuals share the same ID. Passwords are changed periodically and stolen or lost passwords are safely deauthorized to prevent unsolicited entries.

  1. Access control:

 A crucial part of security is to control who has access within the Niagara Framework. Sensitive electronic records and functionalities have restricted access based on role. User authentication mechanisms are in place with access reviews.

Compliance means excellence

Messung India is the leading industrial automation company chosen by a number of businesses for their needs and not without reason. At Messung, we make it a point to provide the best service to our clients. And to ensure that, we take compliance very seriously. 

FDA compliance for implementing 21 CFR Part 11 on the Niagara Framework requires systematic steps and every day effort to maintain the stringent guidelines. Maintaining compliance allows us to keep our high standards of delivery excellence.