Role of Continuous Monitoring Systems in Meeting Regulatory Requirements

How Continuous Monitoring Systems Help Pharmaceutical Companies Meet Compliance 

In the highly regulated biopharmaceutical and life sciences industries, the margin for error is virtually non-existent. Compliance with the Food and Drug Administration (FDA) regulations, Good Manufacturing Practice (GMP), and Good Documentation Practice (GDP) is not just about meeting standards—it's about safeguarding human life. Continuous monitoring of environmental conditions, which directly influence the quality and efficacy of pharmaceutical products, is central to this goal.

Navigating the Complex Landscape of FDA and GMP Regulations 

The FDA's regulatory framework is designed to ensure the safety and effectiveness of drugs distributed within the United States. This encompasses a vast range of criteria from drug development to post-market surveillance. GMP guidelines, which fall under this regulatory umbrella, specifically dictate the operational conditions under which biopharmaceutical products must be produced and stored. They ensure that products are consistently produced with quality in mind, preventing risks such as cross-contamination, incorrect labeling, and deviations from formula. 

21 CFR Part 11 Requirements: The Keystone of Electronic Record-Keeping 

A special focus is placed on 21 CFR Part 11, which sets forth the FDA's criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. The regulation mandates that: 

• Systems that manage electronic records must be validated to demonstrate accuracy, reliability, and consistent intended performance. 
• The ability to generate accurate and complete copies of records for inspection is essential. 
• Protection of records to ensure their authenticity and integrity is critical, as is limiting system access to authorized individuals. 
• Secure, computer-generated, time-stamped audit trails are required so that the sequence of activities concerning the electronic record can be accurately reconstructed. 

Continuous Monitoring Systems and Regulatory Compliance 

Continuous monitoring systems are at the forefront of compliance technology, providing the ability to monitor critical environmental parameters such as temperature, humidity, and pressure around the clock. These systems are invaluable for: 

The latest environmental monitoring equipment, like the ViewPoint® VPx Pro 6 Sensor, boast features that significantly enhance reliability and compliance: 

1. Ensuring that storage and manufacturing conditions remain within specified limits, an essential aspect of GMP compliance. 
2. Providing a full, auditable trail of environmental conditions, crucial for GDP and meeting the stringent documentation requirements of 21 CFR Part 11. 
3. Offering real-time alerts and notifications, which facilitate prompt corrective actions, a requirement under GMP to maintain product quality and safety. 
4. Furthermore, advanced continuous monitoring systems are equipped with features that support 21 CFR Part 11 compliance. They offer secure data logging, user-level access controls, and audit trails that detail when records were made, who made them, and what changes were made, along with the original data. This creates an environment where data integrity is paramount, and compliance is woven into the fabric of daily operations. 

The Role of Technology in Upholding Compliance 

As pharmaceutical companies navigate the complexities of FDA, GMP, and 21 CFR Part 11 compliance, the technology they choose plays a pivotal role.  

The integration of robust continuous monitoring systems, including Mesa’s ViewPoint® software, into biopharmaceutical operations supports compliance goals. The ViewPoint Continuous Monitoring System, including the VPx Pro 6 Sensor, helps biopharma, clinical diagnostics, biotechnology, and life science companies meet the rigorous standards set forth by the FDA.  

Getting Started with Mesa’s Precise, Compliant Continuous Monitoring Solutions 

At Mesa Labs, precision and compliance are at the forefront of everything we do. Explore our Continuous Monitoring solutions and learn how to achieve highly accurate ongoing data collection for key factors like temperature, differential pressure, and humidity monitoring to protect your critical assets and processes.