The FDA has brought new light to its mission to focus on data integrity in the pharmaceutical industry. Thomas Engineering has always made it our prime directive to make the lives and work of manufacturers easier to conduct. We bring the same level of attention to assisting in ensuring your data integrity.
The Meaning of 21 CFR Part 11 and Data Integrity
At Thomas, we’ve learned time and time again that it pays to pay attention to the trends in the pharmaceutical industry. In recent years, there has been a surge from the FDA to focus on the integrity of data throughout all sectors of drug manufacturing. Data integrity itself has become a bit of a catch-all term for the act of maintaining complete records in their original context of data and their relation to other data records.
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In simpler terms, you’ve achieved data integrity when your data records offer validation of necessary services and compliance with the appropriate regulatory bodies that govern your industry. So, how do we judge compliance and validation across so many different manufacturers with so many different products?
Title 21 of the CFR of the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: the FDA, DEA, and ONDCP.
There is a gap between the ideal conditions of data integrity and the reality of the industry. The 21 CFR and compliance teams around the world are working to fill that gap. The 21 CFR part 11 compliant system, in part, pertains to regulating how electronic records should be applied, managed, and recorded.
Are You Prepared to Meet 21 CFR Part 11 Security Requirements?
Thomas has been in the pharmaceutical manufacturing industry for over 60 years. We’ve witnessed the growth of regulatory bodies and adapted the Compu Coat Controls to meet the increasingly stringent data security requirements. Currently, the Food and Drug Administration (FDA) expects your data to be reliable and accurate. Current Good Manufacturing Practice (CGMP) regulations and professional guidance allows for you to take on flexible, risk-based strategies to prevent and identify any data integrity issues.
The FDA also requires the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that initiate, alter, or delete electronic records. They do not want changes to those records to obscure any previously recorded data. It might sound complicated, but all of these precautions and safeguards are there to protect your organization as much as they protect the consumer.
Don’t Let the Complications of Compliance Wear You Down
A positive inspection or review from governing bodies like the FDA speaks to the quality of your products and advertises how much work goes into your process. Electronic documentation like this might not always be exciting, but it’s part of the foundation of the pharmaceutical industry. The experts at Thomas are here to make compliance easier to reach for manufacturers like you.
We design it into every tablet coater, support service, and Compu-Coat control system. Worried about changing regulations in the modern era of technology? That’s not a problem for us, we’ve thought ahead and built our operating systems to be easily upgradeable. This adaptability protects your investment and compliance for the life of your machinery.
Trust Our Quality Control and Compu-Coat Control Systems
In the modern world of electronic controls and paperless systems, ensuring the safety of data is becoming more crucial than ever before. Thomas has been committed to providing the highest level of data integrity possible since our pioneering release of the first automated tablet coating system. That legacy continues today through our latest Compu-Coat systems.
Thomas Compu-Coat control systems excel at meeting all industry standards for CSV, CFR 21 part 11, and protecting customers’ intellectual property. We routinely encourage customers to visit us and audit to the highest level needed to provide complete assurance, along with necessary documentation, that all requirements and expectations are being met.
This comprehensive approach virtually guarantees that regulatory compliance will never be an issue and FDA inspections will have a very positive outcome. To learn more about how we can help with 21 CFR compliance and your data integrity, reach out to Thomas today.