Computerized systems play a key role in today’s pharmaceutical and biotech industries. From data recording to equipment control, they help maintain quality and consistency. But with more use of digital systems comes closer inspection by the U.S. Food and Drug Administration (FDA).
If you’re working under current Good Manufacturing Practices (cGMP), your computerized systems must follow certain legal and regulatory rules. This article explains how the FDA inspects these systems, what laws apply, and what companies should prepare for.
Key Laws and Regulations That Apply
There are three main areas of regulation the FDA uses during inspections of computerized systems:
21 CFR Part 11
This rule covers electronic records and electronic signatures. It applies when:
- Records are kept electronically instead of on paper
- Signatures are captured or stored digitally
- Electronic data is used to meet any FDA requirement
The goal is to confirm that digital data is reliable, accurate, and secure.
21 CFR Part 210/211
These are the general cGMP rules for manufacturing, processing, packing, or holding of drugs. They require that all records and processes support product safety and quality, including electronic systems.
Examples include:
- Batch production records
- Lab controls
- Equipment logs
Any computerized system used for these purposes must follow cGMP rules.
FDA Guidance Documents
While not legally binding like a regulation, FDA guidance gives insight into what inspectors expect. One of the most referenced is:
- “Data Integrity and Compliance With Drug cGMP” (2018)
This document explains how the FDA views data handling, especially with computerized systems.
What FDA Inspectors Look for
When FDA inspectors review your computerized systems, they focus on:
- Data integrity
- Access controls and user roles
- Audit trails
- Validation records
- Backup and recovery
- System security
Here’s how each of these areas may be reviewed:
Data Integrity
Data integrity means that the data is:
- Complete: Nothing is missing
- Accurate: True to what was measured or done
- Consistent: Recorded in the same way each time
- Reliable: Can be trusted for decision-making
FDA inspectors want to see that data is not edited or deleted without a record. They may ask:
- Are raw data files available and unchanged?
- Are records automatically time-stamped?
- Is data entered directly into the system, or copied later?
Access Controls and User Roles
Inspectors check who has access to systems and what they are allowed to do. Questions may include:
- Are user roles defined clearly (e.g., Operator, Supervisor, Admin)?
- Can unauthorized users access the system?
- Can users delete or change data without approval?
The goal is to prevent tampering, whether by accident or on purpose.
Audit Trails
Audit trails are automatic logs that track every action within the system. This includes:
- Who accessed the system
- What was done (e.g., record added, deleted, or changed)
- When it happened
FDA wants audit trails to be:
- Turned on and always running
- Locked so they cannot be edited
- Reviewed regularly
If your system doesn’t have audit trails, or if you can’t show them, inspectors may view that as a red flag.
Validation Documentation
Computer system validation is the process of proving that a system works as intended.
FDA will ask for documents such as:
- User Requirement Specifications (URS)
- Functional Specifications
- Validation Protocols and Reports
- Test Scripts with Pass/Fail Results
They want to confirm that the system:
- Was tested properly before use
- Still performs as expected
- Has been re-tested after any major change
Lack of validation can lead to warning letters or even shutdowns.
Backup and Disaster Recovery
Systems that store data electronically must have ways to back up and restore that data.
During inspections, FDA may ask:
- How often is data backed up?
- Where are the backup files stored?
- Has the company tested the recovery process?
Losing data during a system crash can be a major compliance failure, especially if the data can’t be recovered.
System Security
Security protects systems from unauthorized access, hacking, or malware.
Inspectors may check:
- Password policies (e.g., complexity, expiration)
- Use of firewalls and antivirus software
- Physical security of servers or terminals
- Whether USB ports or external drives are blocked
They also want to know what happens when an employee leaves the company, are their accounts disabled immediately?
Common Mistakes That Trigger Warnings
Several FDA warning letters in recent years have included findings related to computerized systems. Common issues include:
- No validation of systems used for production or testing
- Shared usernames and passwords
- No backup of test data
- Audit trails turned off
- Employees able to delete records without trace
- Incomplete or late entries
These problems often lead to citations under 21 CFR Part 11, Part 211.68, or Part 211.180.
Best Practices to Stay Compliant
Here are a few practical steps companies can take to prepare for FDA inspections:
- Use systems with built-in audit trails
- Create unique logins for all users
- Review access logs and audit trails regularly
- Validate every system before using it
- Update validation after software or hardware changes
- Back up data daily and test recovery often
- Limit admin rights to trained personnel only
- Keep training records for all system users
- Document every step, if it’s not written down, it didn’t happen
Final Thoughts
FDA inspections of computerized systems are becoming more detailed and more frequent. With the growing shift toward electronic records and automated systems, these reviews are now a regular part of cGMP audits.
Companies that follow simple habits, such as validating systems, limiting access, and keeping records clean, will have fewer issues during inspection. It’s not about expensive tools or complex upgrades. It’s about keeping your system trustworthy, your data accurate, and your documentation complete.
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