INSIGHT

FDA 21 CFR Part 11 compliance through managed IT services 

Michael Sellai • October 15, 2025

Services: Managed IT Services Industries: Financial Services

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Your life sciences organization likely deals with constant pressure to maintain FDA 21 CFR Part 11 compliance while managing increasingly complex IT infrastructure. Electronic recordkeeping requirements, audit trail documentation, and electronic signature validation create technical demands that can overwhelm even well-resourced internal teams. A single compliance gap during an FDA audit can halt operations, damage your reputation, and cost millions in remediation. 

Managed IT services give life sciences companies a practical way to achieve and maintain 21 CFR Part 11 compliance without building internal infrastructure from scratch. This article explores how managed IT service providers can help you implement compliant systems, maintain security controls, and prepare for FDA audits.  

Understanding the IT infrastructure demands of 21 CFR Part 11 

FDA 21 CFR Part 11 sets strict requirements for electronic records and electronic signatures in life sciences industries. Your organization must prove that digital records are trustworthy, reliable, and equivalent to paper documentation. This means specific IT infrastructure requirements that need specialized knowledge and continuous monitoring. 

Your systems have to validate user identities and restrict unauthorized access. They must maintain comprehensive audit trails that track every change to electronic records. You need encrypted data storage and secure backup systems. You also need the ability to produce complete, accurate copies of records in human-readable formats when the FDA asks. Each requirement demands robust IT architecture, ongoing system validation, and careful documentation. 

How managed IT services address compliance challenges 

Managed IT service providers bring capabilities that directly support your 21 CFR Part 11 compliance work. They design and implement IT systems with built-in controls that meet FDA requirements. This takes the guesswork out of your compliance strategy. 

Managed IT service providers configure access controls so only authorized personnel can view, modify, or sign electronic records. They set up automated audit trail systems that capture time-stamped records of all user activities. When your team makes changes to electronic records, the managed IT system automatically logs who made the change, when it happened, and what they modified. 

Managed IT services also handle the validation requirements that 21 CFR Part 11 demands. They document how your systems should work and test them to verify that controls function as intended. This validation process creates the evidence you need during audits. 

Security controls and data integrity through managed services 

Your electronic records need protection against external threats and internal vulnerabilities. Managed IT service providers implement multi-layered security controls that protect data integrity. At the same time, they keep records accessible for authorized users. 

Managed IT service providers use encryption protocols that protect data whether it’s stored or being transmitted. They configure firewalls, intrusion detection systems, and monitoring tools. These systems identify and respond to potential security breaches before they compromise your records. 

Password management is another area where managed IT services deliver value. They enforce password complexity requirements and implement regular password changes. They configure systems to lock out users after failed login attempts. These controls prevent unauthorized access while documenting security events in your audit trail. 

Preparing for FDA audits with managed IT support 

FDA audits can happen with little notice. Your ability to quickly produce compliant documentation often determines how the audit goes. Managed IT service providers keep your systems audit-ready so you can demonstrate compliance whenever needed. 

They organize electronic records in formats that meet FDA accessibility requirements. This includes PDF, XML, and other standard formats. They verify that your audit trails are complete, accurate, and immediately available. When auditors request historical records, your managed IT provider can locate and produce the documentation quickly. 

Managed IT services also help you stay compliant between audits. They conduct regular system reviews and spot potential compliance gaps. Then they implement fixes before issues become audit findings. This keeps your organization continuously compliant instead of scrambling when auditors show up. 

Scaling compliance as your organization grows 

When your life sciences organization expands operations, launches new products, or enters new markets, compliance gets more complicated. Managed IT services scale with your business. They adapt systems and controls to meet changing needs without requiring you to build more internal IT capacity. 

Your managed IT provider can quickly deploy new validated systems. They extend access controls to additional users and maintain compliance across multiple facilities or locations. In other words, growth opportunities won’t create compliance vulnerabilities. 

Partner with BPM for comprehensive managed IT support 

BPM understands the challenges life sciences organizations face with FDA 21 CFR Part 11 compliance. Our managed IT services team works with your organization to implement systems that meet regulatory requirements while supporting how you actually operate. We configure compliant infrastructure, maintain security controls, and get your systems ready for successful FDA audits. 

We combine technical implementation with ongoing support to help your compliance stay strong as regulations change and your business grows. We help you turn compliance from a burden into something that actually works for you. This gives you confidence that your electronic records meet the standards they need to. To find out how our managed IT services can strengthen your 21 CFR Part 11 compliance strategy and protect your operations from regulatory risk, contact us.