21 CFR Part 11 Password Policy
Tips for Creating a Compliant Policy for Your Life Sciences Organization
Password security is one of the most essential parts of data encryption in the online world. When you’re dealing with life sciences, biotech, and electronic records, it’s even more critical to get it right—not just for the protection of your files and company information but for compliance with federal regulations. The 21 CFR Part 11 password policy is a core part of how life sciences organizations can stay in compliance. Download the whitepaper “How to Prepare for a 21 CFR Part 11 FDA Inspection“.
The FDA released Title 21 CFR Part 11 in 1997 as the Internet became a place where more and more electronic business was taking place. Despite the evolution of digital technology since that time, the rule has remained largely unchanged. That’s due, in part, to the fact that the regulation was generalized and nonspecific to begin with, simply outlining that electronic records and signatures required as much scrutiny and protection, if not more than, paper records and signatures.
Part of that comes in password compliance. Keeping your team on board with secure passwords can feel like an insurmountable task – people already have dozens of passwords to remember, and they don’t want them to be any more difficult than necessary. For you, though, difficult means safe, and that’s what you need to impress upon your team when coaching password security as part of your onboarding or ongoing training. Get the validated eLeaP platform to stay in compliance.
What Does Title 21 CFR Part 11 Cover?
In addition to passwords, Part 11 covers all kinds of topics related to electronic records, electronic signatures, and data security. This includes:
- Standard Operating Procedures (SOPs)
- System Features
- Infrastructure Qualification
- System Validation
- Security Standards for Roles, Usernames/Passwords, Restrictions, and Logs
- Data Transfer Standards
- Audit Trail Standards
- Electronic Approval Standards
- SaaS/Cloud Hosting Requirements and Responsibilities
Who can benefit from understanding this regulation? All life sciences organizations using electronic records and systems will need to understand and follow CFR Part 11 in order to remain compliant in their operations. This information is also helpful to regulatory professionals, as well as those in IT, quality assurance, auditing, and positions of management. Software vendors and hosting providers should also be well-versed in this policy and what it entails.
What can you do for your team? This guide is a good start to improving password security and compliance. You can also:
- Address the latest industry standards and provide updated LMS training
- Help employees understand the importance and requirements of working with Saas/cloud-hosted solutions
- Implement a risk-based approach to validation to decrease implementation times and lower costs
- Review recent trends and FDA news to understand how improvements can be made to document authoring, review and revision, and final approval
- Take the course “The GAMP Approach to 21 CFR Part 11 Compliance” to stay up-to-date and relevant.
What are the Password Guidelines?
CFR Part 11 password guidelines require that passwords are clean, not reused, and contain multiple combinations of numbers, letters, and special characters. In keeping compliance with Part 11 and protecting your life sciences organization when it comes to electronic systems, the following concerns need to be addressed in policy.
The first concern is password strength. People need to understand that while they might not want to go the extra mile on their personal accounts, there is no option at work. The first choice you have is to assign passwords that are strong enough to meet the demands of today’s systems. You could also allow people to choose their passwords but require certain guidelines to be followed, such as using a certain number of special characters or not repeating passwords previously used.
Password Hygiene and Housekeeping
Passwords need to be dusted off and changed periodically, just like your favorite jeans or the sheets on the bed. Regularly changing passwords (most security companies, and the 21 CFR Part 11 password policy, recommend every 60-90 days) ensures that there is less risk of a data breach because there is less opportunity for the password to be exposed to hackers or other threats.
Consider including a password policy in your employee handbook that covers things like:
- Credential safety
- Password strength
- Password hygiene/housekeeping
- Violations and consequences
Of course, you can’t punish your employees for a data breach – the “violations and consequences” section is just where you will outline what constitutes an outright violation of password safety and security, as well as what happens if someone compromises passwords or the related security of them by sharing information or otherwise not following the password policy.
Go the Extra Mile Regardless of Policy
When it comes to setting up your company for success, security is a primary concern. You should take the initiative to come up with a premium data security protocol for your life sciences company that includes password protection policies for all employees. Cover things like administrative permissions, levels of access, and other important topics so that everyone is on the same page. Provide your users with the chance to get as much information as they can about why password protection matters and how they can be a part of your company’s first line of defense by being smart. You might also want to see if your software vendors can implement 2 Factor Authentication (2FA) in addition to password security. If not sure, contact eLeaP for assistance on 2FA for your solutions, especially your learning management system.
The FDA requires that all electronic systems are adequately secured and that they have the necessary audit trails to prove that all changes and access points are carefully monitored and tracked. It also requires that all of the information that is protected by and specified in CFR Part 11 is shareable and accessible to all, including being able to be printed.
The idea is to ensure that everyone is informed and making the best decisions about things like data security for their company. When you engage the employees and make them an active part of the process, they will better understand the policies and feel more empowered to help keep the company safe. That’s an employee that any company would be lucky to have.
Take the time to sit down and come up with a Title 21 CFR Part 11 password policy that delivers the protection that your company needs but that also meets all necessary guidelines for regulatory compliance. Get your employees on board, and instead of just telling them how to set passwords, teach them why it matters. Your security will start improving in no time, and you’ll ensure that your electronic records are safe from as many threats as possible.