When an FDA inspector asks to see your records, you need to be ready. If you’re using electronic systems, that readiness depends entirely on your adherence to 21 CFR Part 11. This regulation is the foundation of trust for all digital data in regulated industries, covering everything from secure audit trails to legally binding electronic signatures. It ensures that every action is traceable and every record is protected. Feeling unsure where to begin? You’re in the right place. This guide provides a clear and straightforward 21 cfr part 11 compliance checklist to help you systematically address each requirement, ensuring your operations are not just efficient but also fully prepared for any regulatory scrutiny.
Key Takeaways
- Implement essential technical controls: Your electronic systems must have built-in safeguards like validation to prove they work correctly, unchangeable audit trails to track all activity, and strict access controls to protect data integrity.
- Document your processes and train your team: Technology alone isn’t enough. Create clear Standard Operating Procedures (SOPs) for every task involving electronic records and ensure every team member receives and documents role-specific training to follow them correctly.
- Make compliance a continuous habit, not a one-time project: Integrate your Part 11 strategy directly into your Quality Management System (QMS). Maintain compliance by performing regular internal audits, system reviews, and risk assessments to catch and correct issues before they become problems.
What is 21 CFR Part 11?
If your business operates in an FDA-regulated industry, you’ve likely come across the term “21 CFR Part 11.” It sounds technical, but the concept is actually pretty straightforward. This regulation is the FDA’s official set of rules for using electronic records and signatures instead of traditional paper documents and handwritten signatures. In short, it provides the framework to ensure that your digital records are just as trustworthy, reliable, and legally binding as their paper counterparts. It’s the FDA’s way of saying, “Yes, you can go paperless, but here’s how you do it right.”
Think of it as the bridge between old-school record-keeping and modern digital systems. For companies in life sciences, food and beverage, and cosmetics, managing mountains of paperwork is a huge operational challenge that can slow down production and introduce errors. Part 11 allows you to streamline your processes by going digital, but it comes with a critical responsibility: you must prove your electronic systems are secure, traceable, and valid. The regulation isn’t about forcing technology on you; it’s about setting clear expectations for how to use it correctly so that product quality and consumer safety are never compromised. Understanding these requirements is the first step toward building a compliant, efficient, and modern quality system for your business.
Defining the Regulation and Its Scope
At its core, 21 CFR Part 11 establishes the criteria for when the FDA will consider electronic records and signatures to be authentic and valid. It doesn’t force you to use electronic systems, but if you choose to, you must follow these rules. The regulation applies to any electronic records that are created, modified, maintained, archived, retrieved, or transmitted under any FDA regulations. This includes everything from lab results and manufacturing batch records to training documentation and quality control data. The goal is to ensure that your digital data has the same level of integrity and cannot be easily altered without a trace, just like a signed paper document.
Understanding the Key Components
To achieve compliance, Part 11 focuses on a few key areas. First, it requires system validation to prove your electronic system does what it’s supposed to do accurately and consistently. Another critical piece is the audit trail, which must be a secure, computer-generated, time-stamped log that independently records all actions related to creating, modifying, or deleting electronic records. You also need strong operational and security controls to limit system access to authorized individuals and ensure data integrity. Finally, the regulation sets strict standards for electronic signatures, ensuring they are as legally binding as a handwritten signature.
Who Needs to Comply?
Any company that falls under FDA regulations and uses electronic systems to manage records must comply with 21 CFR Part 11. This includes a wide range of industries, from pharmaceutical and medical device manufacturers to biotech companies and clinical research organizations. If your business produces drugs, biologics, dietary supplements, or even certain cosmetic products for the US market, these rules apply to you. Essentially, if you are required to maintain records by the FDA and you choose to do so electronically, you need a solid plan for Part 11 compliance to avoid regulatory issues and ensure your data stands up to scrutiny.
Meet the Requirements for Electronic Records
When you move from paper to digital, the FDA wants to know your electronic records are just as trustworthy. 21 CFR Part 11 lays out the ground rules for ensuring your digital data is authentic, secure, and reliable. Think of these requirements as the foundation of your compliance strategy. Getting your electronic records in order isn’t just about passing an audit; it’s about building a robust system that protects your data, your products, and your customers. It all starts with validating your systems and ensuring every piece of data has a clear, traceable history.
Validate Your Systems
System validation is the process of formally documenting that your computer systems consistently do what they are supposed to do. You need to prove that your systems are accurate, reliable, and perform as intended every single time. This isn’t a one-and-done task; it’s an ongoing commitment to maintaining a controlled environment. A key part of this is security. You must restrict access to critical files to authorized personnel only and have a way to detect and report any unauthorized access attempts. The FDA provides detailed guidance on software validation to help you establish the right procedures for your operations.
Create Compliant Audit Trails
An audit trail is a secure, computer-generated log that chronicles every action related to an electronic record. It answers the critical questions: Who created, modified, or deleted a record? When did they do it? What exactly was changed? According to 21 CFR Part 11, these audit trails must be automatically generated and impossible to alter or delete. This creates an unchangeable history for every record, providing the traceability and accountability that regulators need to see. A robust audit trail capability is non-negotiable for any system that manages GxP-regulated data, as it serves as the definitive record of your data’s lifecycle.
Ensure Data Integrity
Ultimately, the rules for validation and audit trails are all in service of one core principle: data integrity. This means ensuring your electronic data is accurate, complete, and secure throughout its entire lifecycle. Adhering to these regulations is essential for maintaining product quality and ensuring consumer safety. When your data is reliable, you can make confident decisions about your products and processes. The FDA takes this very seriously, as compromised data can have significant consequences. Following the principles of data integrity is fundamental to building a culture of quality within your organization.
Follow Record Retention Rules
Creating compliant records is only half the battle; you also have to store them properly. Your company must maintain accurate copies of all electronic records and ensure they are easily accessible for their entire required retention period. If an inspector asks for a record from three years ago, you need to be able to pull it up quickly and in a readable format. This requires a clear and consistent record retention policy that outlines how long different types of records are kept and how they are stored. Your systems should make it simple to archive and retrieve data without compromising its integrity.
Handle Electronic Signatures and Authentication
When you move from paper to digital records, you need a reliable way to show approval and accountability. That’s where electronic signatures and user authentication come in. Think of an electronic signature as the digital equivalent of a handwritten one—it’s a legally binding mark that shows a specific person reviewed and approved a record at a specific time. Authentication is the process of verifying that the person signing is exactly who they claim to be.
Under 21 CFR Part 11, these two elements are non-negotiable. They form the backbone of a trustworthy electronic system, ensuring that every action is traceable to an authorized individual. Without robust signature and authentication controls, your electronic records lack the integrity required for regulatory scrutiny. The FDA’s guidance makes it clear that these measures are essential for ensuring product quality and safety in a digital environment. Getting this right is fundamental to your compliance strategy.
Meet Electronic Signature Standards
For an electronic signature to be compliant, it can’t just be a typed name. It must contain several key components that link it directly to the signer and the record. Each signature needs to include the signer’s full printed name, the exact date and time it was applied, and a “signing statement” that explains its meaning—such as “Reviewed,” “Approved,” or “Authored.” Most importantly, the signature must be securely linked to its specific electronic record, making it impossible to copy, move, or apply to any other document. This ensures the signature’s context and intent are always clear and unchangeable.
Authenticate Your Users
Before your system accepts an electronic signature, it must first confirm the user’s identity. This is authentication. The goal is to ensure that only authorized individuals can access the system and perform specific actions, like approving a document. Every user must have a unique ID and password to log in. These credentials act as the first line of defense, proving that the person at the keyboard is who they say they are. Your system should also enforce password security rules, such as minimum complexity and periodic changes, to protect against unauthorized access and maintain the integrity of your records.
Document Your Processes
Having compliant technology is only half the battle; you also need to document your procedures for using it. This means creating and maintaining clear Standard Operating Procedures (SOPs) that outline how you manage electronic signatures and user authentication. Your documentation should cover everything from how you issue and retire user accounts to the steps employees must follow when signing a record. These written procedures demonstrate to auditors that you have a controlled, consistent process in place and that your team is trained to follow it correctly. Without this documentation, it’s difficult to prove your system is operating in a compliant manner.
Implement Best Practices
The most effective way to handle electronic signatures and authentication is by using software designed for compliance. An Enterprise Quality Management System (eQMS) can simplify the entire process. These platforms come with built-in features that meet 21 CFR Part 11 requirements, including secure, multi-component electronic signatures and role-based access controls. An eQMS automatically creates unchangeable audit trails that track all activities, providing a complete history of every record. By implementing a quality management system, you can centralize your compliance efforts and ensure your processes are consistent, secure, and always ready for an audit.
Implement Security and Access Control
Protecting the integrity of your electronic records is a cornerstone of 21 CFR Part 11. This means building a secure environment where data is safe from unauthorized access, alteration, or deletion. Think of it as creating a digital fortress around your most critical information. Implementing strong security and access controls isn’t just about checking a box for the FDA; it’s about ensuring the reliability and trustworthiness of your data, which is the foundation of your product quality and safety. A well-designed system limits access to only those who need it and tracks every action, creating a clear and defensible record of your operations. This section walks you through the essential layers of security you need to put in place to protect your records and your business.
Secure Your Systems
Your electronic records must be protected by robust security measures. This starts with the basics, like enforcing strong, unique passwords for all users and implementing multi-factor authentication wherever possible. But true system security goes deeper. You should ensure your systems are protected by firewalls and that sensitive data is encrypted both when it’s stored and when it’s being transmitted. The goal is to create a layered defense that makes it difficult for unauthorized individuals to access information. Regularly review and update your security protocols to address new threats and vulnerabilities, ensuring your cybersecurity framework remains effective over time.
Control User Access
Not everyone in your organization needs access to every file or system function. Part 11 requires you to limit system access to only authorized individuals. The best way to manage this is through role-based access control (RBAC), where permissions are assigned based on a person’s specific job responsibilities. For example, a lab technician might have permission to enter data, while a quality assurance manager has rights to review and approve it, but neither can alter the system’s core programming. This principle of “least privilege” is critical for preventing accidental or malicious changes to records. Documenting these roles and permissions clearly demonstrates to auditors that you have full control over user access.
Manage System Changes
Any change to a validated system—from a software update to a configuration tweak—can impact its compliance status. That’s why you need a formal change control process. This procedure ensures that all modifications are properly documented, tested, and authorized before they go live. Your change control process should outline the steps for proposing, reviewing, and implementing changes, as well as the validation activities required to confirm the system still works as intended. Keeping a detailed log of all system changes provides a clear history for auditors and proves that you are maintaining your systems in a constant state of control and compliance.
Assess Your Risks
A proactive approach to compliance involves regularly assessing the risks to your electronic records. This means identifying potential vulnerabilities in your systems and processes and evaluating their potential impact on data integrity and regulatory compliance. The FDA encourages a risk-based approach, as it allows you to focus your resources on the areas of highest concern. Your risk assessment should be a living document, updated periodically or whenever significant changes occur. This ongoing process helps you find and fix potential issues before they become major problems, ensuring your systems remain secure and compliant over the long term.
Validate Your System and Keep Records
Having compliant systems is one thing, but proving they work correctly and consistently is another. This is where validation and record-keeping come in. Think of it as creating a detailed history for your electronic records that can stand up to scrutiny. It’s about showing, not just telling, regulators that your processes are under control.
This involves regularly testing your systems to confirm they meet their intended use, documenting every action taken on a record, and establishing clear procedures for your team to follow. Proper validation and documentation build a strong foundation for your compliance efforts, ensuring that your electronic records and signatures are trustworthy and reliable. It’s a critical step that demonstrates your commitment to quality and regulatory adherence. At J&JCC Group, we can help you establish a robust quality management system that makes this process straightforward.
Follow the Validation Process
System validation is the process of confirming that your electronic systems do exactly what you expect them to do, every single time. You need to prove that your software is reliable for its intended tasks. This starts with creating detailed documentation, like a user requirements specification, that outlines precisely how the system is supposed to work. Then, you must perform rigorous tests to show that it actually performs those functions correctly and consistently under various conditions. It’s not a one-time check; validation is an ongoing activity. You’ll need to re-validate whenever you implement significant system updates or changes to ensure continued compliance. This documented evidence is your ultimate proof to the FDA that your systems are fit for purpose and your data is trustworthy.
Prepare the Necessary Documentation
Your systems must create secure, computer-generated audit trails for every electronic record. An audit trail is a detailed, time-stamped log that tracks the entire lifecycle of a record: who created it, when they modified it, and what specific changes were made. Crucially, these audit trails must be un-editable and generated automatically by the system, independent of any operator action. This creates an unchangeable history that ensures the integrity of your data. Think of it as a permanent digital footprint for every action. This documentation is essential for demonstrating accountability and transparency during an FDA inspection. It allows an auditor to reconstruct any event, showing exactly what happened to a record and who was responsible at every step.
Develop Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) are the backbone of consistent operations and a key part of your quality system. You need to create and maintain clear, written instructions that define how your team uses electronic systems and handles electronic records. These procedures should cover everything from data entry and record modification to user access controls, data backup, and system maintenance. For example, your SOPs must detail the exact process for reviewing and approving documents before they are put into use. It’s also important to have procedures for version control and ensuring that only the current, approved SOPs are accessible to staff. Having well-defined SOPs ensures everyone performs their tasks in a standardized, compliant manner, reducing the risk of human error and process deviations.
Train Your Team Effectively
A compliant system is only effective if your team knows how to use it correctly. Every person who interacts with your electronic record systems must receive adequate training for their specific role and responsibilities. This training should cover the relevant SOPs, the technical aspects of the system, and the importance of following Part 11 regulations. It’s not enough to just hold a session; you must also document this training thoroughly. Keeping detailed records for each employee—including dates, topics covered, and assessments of understanding—demonstrates to regulators that your team is qualified and competent. Ongoing or refresher training is also crucial, especially when procedures or systems change. We offer specialized employee training services to ensure your staff is fully prepared to meet and maintain compliance standards.
Integrate with Your Quality Management System (QMS)
Think of your Quality Management System (QMS) as the central hub for your compliance efforts. Integrating your 21 CFR Part 11 strategy directly into your QMS isn’t just a good idea—it’s the most effective way to ensure consistency and control across all your electronic records and signatures. A well-integrated system helps you manage everything from document control to employee training under one cohesive framework, making your processes much easier to manage and audit.
Using a modern, cloud-based QMS can simplify things even further, especially when it comes to handling digital signatures and maintaining accessible records. By weaving Part 11 requirements into your existing quality processes, you create a sustainable compliance culture rather than treating it as a separate, one-off project. This approach helps you stay organized, reduces the risk of non-compliance, and makes it easier to demonstrate control to FDA inspectors. The goal is to make compliance a natural part of your daily operations, not an extra burden.
Select Compliant Software
Choosing the right software is one of the most critical steps you’ll take. To meet 21 CFR Part 11 rules, you need to use reliable software that was specifically built for regulated environments. Generic tools that are retrofitted for compliance often have gaps that can put you at risk. Investing in a dedicated electronic quality management system is a smart move because it’s designed with these regulations in mind. This software helps you meet compliance rules, makes document management more efficient, and significantly reduces the chance of human error. Look for systems that have built-in features for audit trails, electronic signatures, and access controls right out of the box.
Manage Your Documents
Your QMS must ensure that all electronic records are properly managed throughout their lifecycle. According to the regulation, you must keep accurate copies of your electronic records, and they need to be easy to find and access whenever required. This means your system should allow you to create, keep, and store electronic records in a way that guarantees they are accurate, readable, and readily available for review. Think about version control, secure storage, and straightforward retrieval processes. Your document management strategy should be robust enough to protect data integrity while making it simple for authorized personnel to access the information they need to do their jobs.
Implement Audit Trails
Audit trails are the backbone of data integrity under 21 CFR Part 11. They are non-negotiable. Your systems must create secure, computer-generated, time-stamped records that document every single action related to an electronic record. This includes creating, modifying, or deleting any data. These clear, time-stamped records must show who made a change, what the change was, and when it was made. The audit trail needs to be automatically generated and impossible to alter or turn off. This provides a complete, unbiased history of your data, which is essential for demonstrating compliance and investigating any discrepancies that may arise.
Organize Team Training
Even the most advanced QMS is only as effective as the people who use it. That’s why comprehensive team training is a core requirement of 21 CFR Part 11. Everyone who uses your electronic systems, from the lab technician entering data to the quality manager approving documents, must receive the necessary training to perform their specific roles correctly. The FDA is clear that ensuring people are properly trained and experienced is a key responsibility. Your training program should cover not only how to use the software but also why compliance is so important. Document every training session, and make sure your team understands their responsibilities in maintaining data integrity.
Build Your 21 CFR Part 11 Compliance Checklist
Tackling 21 CFR Part 11 can feel like a huge undertaking, but breaking it down into a checklist makes the process much more manageable. Think of it as your roadmap to compliance. A well-structured checklist helps you organize your efforts, assign responsibilities, and track your progress without getting overwhelmed. It ensures you don’t miss any critical steps, from initial system assessments to ongoing maintenance. This systematic approach not only prepares you for an FDA inspection but also strengthens your internal processes, leading to better data integrity and quality management overall.
Creating this checklist is the first actionable step toward building a robust compliance framework. It transforms a complex regulation into a series of concrete tasks. Below, we’ll walk through the key areas your checklist should cover. Each step is designed to build upon the last, creating a comprehensive plan that addresses every major component of the regulation. Whether you’re implementing a new system or bringing an existing one into compliance, this framework will guide you through the essential activities needed to meet the FDA’s requirements for electronic records and signatures.
Assess Your Current Systems
First things first, you need to know where you stand. Start by taking a complete inventory of all the electronic systems you use to create, modify, maintain, or transmit records governed by the FDA. This includes everything from laboratory information management systems (LIMS) to your document control software. For each system, you need to evaluate its current capabilities against Part 11 requirements. The regulation states, “You must regularly check your electronic systems to make sure they work correctly and consistently.” This process starts with a thorough gap analysis to identify where your systems fall short, giving you a clear picture of the work ahead.
Define System Requirements
Once you know what you have, you can define what you need. This step involves creating a clear set of requirements for your systems to ensure they are Part 11 compliant. Your requirements should cover access controls, audit trails, and electronic signature functions. According to compliance guides, “Companies must have ways to make sure only approved people can look at, change, or approve electronic records.” This means your systems must be able to enforce user permissions, create secure audit trails that can’t be altered, and link electronic signatures to their specific records. Documenting these requirements is crucial for both system validation and future procurement decisions.
List Documentation Needs
Compliance isn’t just about having the right technology; it’s about proving it. You need comprehensive documentation to demonstrate that your systems and processes meet Part 11 standards. This includes policies, standard operating procedures (SOPs), validation plans, test records, and training logs. A key principle is that “You must keep copies of your electronic records, and they need to be easy to find and access.” Your documentation plan should outline what needs to be documented, where it will be stored, and how it will be maintained. Following Good Documentation Practices is essential for keeping your records organized, accessible, and inspection-ready.
Outline Training Plans
Your team is your first line of defense in maintaining compliance. Even the most sophisticated system can fail if users don’t know how to operate it correctly. That’s why a detailed training plan is a non-negotiable part of your checklist. The regulation is clear: “All people who use these systems must get the necessary training to do their jobs correctly.” Your plan should identify who needs training, what topics will be covered (including their specific duties and the Part 11 requirements), and how often training will occur. Remember to document every session, as training records are a key piece of evidence for auditors. Our expert employee training services can help you develop a program tailored to your team’s needs.
Detail Validation Steps
System validation is the process of proving and documenting that your system works as intended and meets all regulatory requirements. It’s a critical step that demonstrates your system’s reliability. Your checklist should include a clear plan for validation, starting with a Validation Plan that outlines the scope, approach, and responsibilities. The goal is to “Make sure your computer systems are accurate, reliable, and work consistently.” This involves rigorous testing to challenge the system’s functions, security, and data integrity. The results are then compiled in a Validation Summary Report, which serves as the official record that the system is fit for its intended use.
Plan for Maintenance
Compliance doesn’t end after validation. You need a plan for ongoing maintenance to ensure your systems remain in a compliant state over their entire lifecycle. This includes procedures for change control, periodic reviews, and data backup and recovery. As experts often note, “Using advanced document management software or an Enterprise Quality Management System (eQMS) is the best way” to manage these ongoing activities. An eQMS can help automate reviews, manage changes, and maintain a clear audit trail. Your maintenance plan should also cover how you’ll handle system updates, patches, and eventual retirement, ensuring you remain compliant through every phase. We can help you implement effective quality management systems to streamline this process.
Maintain Ongoing Compliance
Achieving 21 CFR Part 11 compliance is a significant milestone, but the work doesn’t stop there. Think of it less like crossing a finish line and more like adopting a new fitness routine—it requires consistent effort to maintain. Ongoing compliance is a continuous process of monitoring, reviewing, and adapting to ensure your systems and procedures remain effective and aligned with FDA regulations. As your business grows, introduces new technology, or refines its processes, your compliance strategy must evolve alongside it.
Building a culture of compliance means integrating these practices into your daily operations. It’s about making sure that every team member understands their role in protecting data integrity and that your electronic records are always secure, accurate, and ready for an inspection. A proactive approach not only keeps you on the right side of the FDA but also strengthens your quality management system, reduces risks, and builds trust with your customers. The following steps will help you create a sustainable framework for maintaining compliance long-term, turning a regulatory requirement into a business asset.
Conduct Regular System Reviews
One of the most important habits to develop is conducting regular reviews of your electronic systems. This goes beyond a simple check to see if everything is running. You need to verify that your systems are functioning correctly and consistently, just as they were intended to when you first validated them. Maintain clear documentation that outlines how each system is supposed to operate. During your reviews, compare the system’s actual performance against this documentation. This process helps you catch any deviations or performance issues early before they can become larger compliance problems.
Perform Internal Audits
Regular internal audits are your secret weapon for staying inspection-ready. These audits act as a health check for your compliance program, allowing you to verify that your electronic records and processes meet all established standards. By proactively examining your own systems, you can identify and address any gaps or discrepancies on your own terms. This practice ensures your systems are working as intended and that your team is consistently following the correct procedures. Think of it as a dress rehearsal for an official inspection—it helps you find and fix issues before an auditor does.
Keep Your Systems Updated
Technology is always changing, but even your older, legacy systems need to remain compliant. It’s common for critical processes to rely on established software, and these systems are not exempt from 21 CFR Part 11 requirements. It’s essential to maintain proper documentation for every system, regardless of its age. This documentation should detail the system’s operational status, track any changes or updates made over time, and clearly explain how it continues to meet regulatory requirements. Proper management ensures that even your most trusted systems remain secure and compliant.
Monitor Your Compliance Continuously
Manually tracking every single action across all your systems isn’t practical. The most effective way to ensure ongoing compliance is to use software designed for the job. An Enterprise Quality Management System (eQMS) or a specialized document management solution can automate much of the monitoring process for you. These platforms can automatically generate secure, computer-generated, and time-stamped audit trails that are impossible to alter. This creates an immutable record of all actions related to your electronic records, simplifying monitoring and making it much easier to demonstrate compliance during an audit.
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Frequently Asked Questions
Does 21 CFR Part 11 apply to my small cosmetics or dietary supplement company? Yes, it absolutely can. The regulation isn’t based on the size of your company but on your activities. If you are required by the FDA to keep records (like batch records or quality control data) and you choose to manage them electronically, then Part 11 applies to you. It ensures that your digital records are just as reliable and secure as paper ones, which is crucial for any regulated product.
What’s the real difference between a simple digital signature and a compliant electronic signature? Think of a compliant electronic signature as a much more secure and detailed version of a handwritten one. It’s not just your typed name. A Part 11-compliant signature must include your full name, the date and time you signed, and the specific meaning of the signature, such as “Reviewed” or “Approved.” Most importantly, it must be permanently linked to that specific document, making it impossible to copy or alter.
Do I need to throw out all my current software to become compliant? Not necessarily. The first step is to perform a gap analysis to see how your current systems measure up against the regulation’s requirements. Some software may already have compliant features that just need to be configured correctly, while others might need procedural controls built around them. While sometimes investing in a new system designed for compliance is the easiest path, you should always assess what you have before making any big changes.
What is an audit trail, and why is it so important? An audit trail is essentially a secure, behind-the-scenes log that automatically records every action taken on an electronic record. It answers the questions of who, what, and when—who made a change, what exactly was changed, and when it happened. This log must be computer-generated and impossible to edit. It’s so important because it provides undeniable proof of your data’s history, ensuring complete traceability and accountability for regulators.
Is system validation a one-time event, or is it ongoing? System validation is definitely an ongoing process, not a one-and-done task. You perform the initial validation to prove the system works as intended before you start using it. However, you must re-validate the system any time you make a significant change, like a major software update or a change in its configuration. This ensures the system remains in a constant state of control and continues to meet regulatory requirements throughout its entire lifecycle.