Gone are the days of having to manually record and document critical points of a product throughout its lifecycle. In this modern day and age, technology can verify that a controlled environment has been consistently maintained to preserve and protect sensitive products from manufacturing through distribution. To accommodate these technological advances, government agencies have established regulations to supervise a world that’s gone paperless.
What is 21 CFR Part 11 Compliance?
The Code of Federal Regulations (CFR) are rules and regulations published by departments and agencies of the federal government. The CFR is divided into 50 titles that represent different topics, with Title 21 governing food, pharmaceuticals and medical devices. Part 11 defines the law under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records.
Audit Trails
Under 21 CFR Part 11, the Food and Drug Administration (FDA) implements other requirements including audit trails to provide a chronological record of activities that may influence an operation or product. Just think of an audit trail as the computer-generated, time-stamped “who, what, when, and why” of a record.
Audit trails ensure quality control and regulatory compliance. For example, the credibility of clinical trials is dependent on the audit trail that proves the stability of the research and storage environment. Fluctuations in temperature and humidity can significantly affect potency, so without proof of environmental stability, it’s impossible to guarantee the effectiveness or safety of a product.
Current Good Manufacturing Practice
Defined by the FDA, 21 CFR Parts 210, 211 and 212 highlight the Current Good Manufacturing Practice (CGMP) for drugs. A main component of CGMP is data integrity, which is the assurance of accuracy and consistency of data. Since it is the industry’s responsibility to ensure safety, efficacy, and quality, the FDA expects that data to be reliable in order to protect public health.
Medicines and Healthcare Regulatory Agency
Similar regulations have been implemented in the United Kingdom through the Medicines and Healthcare Regulatory Agency (MHRA). The MHRA requires organizations to comply with Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) to ensure medicines are consistently stored, transported and handled under suitable conditions.
GDP guidelines state, “An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions.”
Following a mapping exercise, the MHRA suggests temperature monitoring devices be strategically placed according to results, especially in areas that experience extreme fluctuations. Ambient products are also temperature sensitive, so conducting a mapping exercise will help establish proper and unsuitable storage areas for perishables.
Monitoring Solutions
Let’s face it, manual monitoring is time consuming and susceptible to human error. That’s why wireless data logging systems have become an industry must-have. Wireless data loggers provide an efficient way to constantly monitor temperature controlled facilities, storage rooms and coolers. MadgeTech’s line of wireless data loggers provide real-time monitoring and configurable alarm notifications, including email and text message.
MadgeTech data loggers used in conjunction with the MadgeTech 4 Secure Software aid in compliance with 21 CFR Part 11 requirements. The software meets standards in which electronic files are considered equivalent to paper records and contains criteria such as electronic signatures, access codes, secure data file and an audit trail.
To learn more about how MadgeTech data loggers can be beneficial for your facility, click here.
