Learn why FDA Part 11 compliance is essential for integrity in the pharmaceutical, biotechnology, and medical device industries. Discover the impacts of non-compliance and the importance of secure electronic records.
Knowing how serious the Part 11 of Title 21 CFR regulations of the FDA are, is the best way to ensure integrity and trust in the industry.
Part 11 of Title 21 CFR, Electronic Records; Electronic Signatures, is an essential set of regulations for any company involved in the pharmaceutical, biotechnology or medical device industries and it stems from the U.S. Food and Drug Administration (FDA).
Adherence to these strict regulations is essential in proving the purity, reliability and efficiency of products in these fields. Failure to adhere Part 11 can lead to serious ramifications, such as fines, product recalls and criminal prosecution.
This is an important reminder about seriousness of Part 11 compliance and the repercussions for not complying with it, which is why this needs to be enforced in FDA-regulated industries.
Maintain the Data Authenticity and Integrity
The purpose of Part 11 is to establish the authenticity, integrity, and trustworthiness of electronic records and signatures used in FDA-regulated industries. All electronic records and signatures that are part of the processes under FDA regulations must comply with the requirements in Part 11.
Sustain and assure the quality of the data driving product safety and efficacy in support of this invaluable standard
Impact of Not Complying:
a. Financial Penalties and Reputational Damage:
Companies that do not implement good security practices in the interests of protecting electronic records and signatures are vulnerable to fines, financial penalties etc. All of those can cause the company to lose a lot, sometimes more than just money, but also users and investors.
b. Product recalls and legal ramifications:
Should non-compliance occur, products can be recalled after the FDA finds inaccuracy, incompleteness/ unreliability in electronic records and signatures. Product recalls can result in significant financial loss, lawsuits and irreparable brand damage which can take years to recover from in the market.
c. Delays in Regulatory Approvals:
Not adhering to Part 11 could lead to FDA rejecting important submissions which could delay the new product approval process. Delayed approvals can make or break the market entry of products that could potentially save lives. It deprives patients treatments that are vital for their health.
Setting in Place Sturdy Compliance Regulations
Invest in the installation of rigorous checks and balances, policies, and security in order for companies to be compliant and avoid facing hefty consequences
These controls consist of strong security measures such as dentification of users, adequate safeguards for preventing unauthorized access to electronic records, Identification measures, Safeguards to prevent misuse of individual authentication features which ensure that their electronic record and signature cannot be unlawfully tampered.
Such aspect of keeping electronic records is important in remaining Part 11 compliant as they cannot be stored for safe and easy recall unless the accuracy, completeness, and retrievability are ensured.
Conclusion: Safeguarding Integrity in Regulated Industries
Part 11 compliance is not just a regulatory requirement, it is also the most important line of defense that ensures the safety and reliability of products in FDA-regulated industries.
This means that companies working in these spaces must make sure that their security protocols are as airtight as possible to protect not only their own reputation but also avoid fines by performing due diligence for Part 11 requirements.
Businesses knowing what is on the line and installing aggressive compliance checks, will secure electronic records and signatures to uphold reputable business practices that prioritize integrity and professionalism in their field.
Get in touch with BioBoston Consulting now or visit our website to discover how we can be of support to your organization.
