How to Implement a Chain of Custody Program in Your Lab

A chain of custody (CoC) program is critical to ensure the accuracy, reliability, and integrity of your lab. 

At its core, a chain of custody program is a documented system to track and maintain records in your lab. This will vary based on your lab’s industry and size, but the process should be similar from lab to lab. In this guide, we’ll share the exact steps to follow to implement a proper chain of custody program in your lab and share the best tools to set you up for success.

What is a Chain of Custody Program?

A chain of custody program is nothing more than a documented system to track and maintain detailed records of your lab.

This record should include the handling, movement, and location of samples and materials in your lab from the moment they are collected to the second they are disposed of. A chain of custody program records who had possession of an item at any given time, when they had it, where it was, and what was done with it.

Think of it like a detailed tracking system, a bit like when you order something via UPS. 

A chain of custody program must include the following:

• Documentation of every person who handles the item
• Time and date stamps for each transfer
• Purpose of each transfer
• Storage locations and conditions
• Any testing or processing performed
• Security measures to prevent tampering
• Signatures or authentication from authorized personnel

Why Your Lab Needs a Chain of Custody Program

Beyond the obvious fact that any organized lab should know where samples and materials are being stored and how they are used, there are a few other reasons why your lab needs a chain of custody program. 

Those reasons include:

• Legal requirements and defensibility: Your lab must comply with regulatory requirements for documentation, prove its results are based on properly handled samples in legal cases, provide evidence for court proceedings, and ensure test results cannot be challenged due to improper documentation.
• Quality assurance: Chain of custody ensures sample integrity throughout testing. This prevents contamination or mix-ups, documents handling procedure deviations, and helps identify the source of problems if results come into question.
• Accountability: A CoC creates clear responsibility for samples at every stage. It also identifies all handlers and timing, prevents unauthorized access, and provides complete traceability if issues arise.
• Regulatory compliance: Chain of custody is essential for compliance. If you want to meet FDA, EPA, or ISO standards or GMP compliance, then it is a necessity. 
• Risk management: Chain of custody protects labs from liability claims, reduces handling and processing errors, creates documentation for insurance purposes, and helps defend against accusations of negligence or misconduct.

A good chain of custody program is not just a matter of keeping your records in order, it’s a core competency of a compliant and reliable lab. Read on as we share the steps to follow to implement one in your lab

How to Implement a Chain of Custody Program: Step-by-Step

Implementing a chain of custody program does not need to be a daunting process. Simply follow the steps below:

1. Initial planning and assessment
2. Policy development
3. Documentation
4. Security measures
5. Staff training
6. Validation and testing
7. Quality control 
8. Continuous improvement

Initial planning and assessment

Before implementing any chain of custody program, your lab must thoroughly evaluate its current workflows and identify critical points where custody documentation is essential. 

This involves analyzing the following:

• Existing processes
• Determining which samples require chain-of-custody tracking
• Understanding applicable regulatory requirements
• Assessing your lab's readiness for implementation. 

A careful review of current gaps and pain points will help shape a more effective program.

Policy development

Next, it’s time to create comprehensive and well-documented policies. 

These policies should clearly outline standard operating procedures, define roles and responsibilities, establish documentation requirements, and specify handling protocols for different types of samples. The policy documentation needs to address every aspect of the sample lifecycle, from collection through disposal, ensuring compliance with relevant regulations and industry standards.

Documentation

Documentation is a key component of a good chain of custody program (and often a centerpiece in passing regulatory compliance requirements).

Whether your lab uses physical paper, Google Drive, or a LIMS, your documentation must capture all essential information such as dates, times, personnel involved, sample details, and any actions taken. To “level up” your documentation and reduce human data entry errors, we recommend relying on barcode labels for each sample. This allows technicians to simply scan a code rather than type out sample IDs, saving time and reducing errors. 

Note that some regulatory requirements, such as ISO 17025, will have specific documentation requirements. It’s important to review the standards you wish to meet to ensure compliance. 

Security measures

Next comes security. Proper security controls protect the integrity of samples in your lab and their associated documentation.

This includes physical and electronic security measures, such as access logs and electronic signatures, to ensure that only authorized individuals can access key data. Many LIMS come with a host of security features, including role-based access for users, regular data backups, and more. 

Staff training

A properly structured chain of custody is one thing, but implementing it is another. 

The success of your chain of custody program will depend on how your staff follows it. To ensure that it is properly implemented, regular comprehensive training is advised. This ensures that your staff knows their roles, especially as your lab's systems and processes change. 

If your lab uses software or automation features like barcode scanners, ensure that your staff is properly trained to use these tools and follows set procedures. Standardizing how labels are printed and attached will make the CoC process faster, more intuitive, and less prone to human error. 

Validation and testing

Before full implementation, the chain of custody program must be thoroughly tested to ensure it works as intended. 

Validation and testing involve conducting trial runs, testing different scenarios, and validating that all documentation methods and security measures function properly. Validation helps identify potential weaknesses or gaps that need to be addressed before the program goes live.

Quality control 

Regular monitoring and oversight ensure the chain of custody program maintains its effectiveness. 

This includes conducting periodic audits of documentation, reviewing compliance with established procedures, and addressing any discrepancies or breaks in the chain of custody. Quality control measures help maintain

Continuous improvement

No matter how much effort you expend, no chain of custody program is perfect from the start. 

Regular evaluation and refinement based on user feedback, audit results, and changing requirements help the program evolve and improve over time. This ongoing process ensures the program remains effective, efficient, and compliant with current standards and regulations.

Common Mistakes Labs Make When Implementing a Chain of Custody Program

If you are implementing a chain of custody program for the first time in your lab, let us warn you of the following common pitfalls to watch out for:

• Inadequate training: Many labs rush through initial training or fail to provide ongoing education, leading to inconsistent documentation and procedural errors. Staff members might not fully understand the importance of each step or the legal implications of improper documentation.
• Overcomplicated Procedures: Some labs create unnecessarily complex documentation requirements that bog down workflow efficiency. This often leads to staff taking shortcuts or making mistakes because the process is too cumbersome to follow consistently.
• Poor Technology Integration: Labs often try to do everything manually with pen and paper or spreadsheets. This is a big mistake, and we strongly recommend avoiding it by using software like a LIMS. By centralizing your data in a LIMS and automating data capture through features like barcode scanning, you can reduce errors, save time, and improve compliance. 
• Insufficient security controls: Many labs focus on documentation but neglect physical and digital security measures. This might include weak access controls, inadequate sample storage security, or insufficient audit trails for electronic systems.
• Incomplete documentation standards: Some labs fail to establish clear standards for what information must be recorded, leading to inconsistent or insufficient documentation that wouldn't hold up to legal scrutiny. Again, this is a common problem for labs not using software for document storage and management.
• Inadequate quality control: Some labs don't implement regular audits or reviews of their chain of custody procedures, allowing small issues to develop into significant problems over time.

Leveraging software in your lab to automate tasks, integrate instruments, and standardize data can avoid many of these problems. Read on as we share the best software for establishing a CoC program. 

The Best Software to Help You Implement a Chain of Custody Program

While you can certainly get by with pen and paper or spreadsheets (after all, labs have been doing it for decades), we’d advise considering software to help implement your chain of custody program. 

Physical records and spreadsheets are brittle. They are easily lost or over-written and can lead to data capture errors or security breaches, among other compliance risks. 

Software like a LIMS provides a cloud-hosted and secure solution to all your woes. A LIMS (laboratory information management system) centralizes the data in your lab, integrates with and monitors instruments, helps you meet compliance requirements and more. 

Which is the best LIMS on the market? We’d suggest QBench!

According to G2’s Top LIMS Rankings, QBench is the best LIMS in 2025. QBench is flexible enough to adapt to any workflow without being overwhelming or requiring custom code.

QBench offers:

• A built-in QMS
• Extensive audit trails for every action taken by users
• Regular data backups, ensuring your data is secure and available no matter what
• Barcode generation and scanning integrations to log sample movement at every stage throughout your lab
• A RESTful API
• Unparalleled flexibility through no-code automations
• Numerous software and instrument integrations

And much more. QBench laps the competition on the pace of product improvement by releasing product updates every three weeks, many of which contain new features that customers requested. 

When you choose QBench, you're not just choosing a LIMS but a partnership that will grow with your lab. Partner with QBench to keep your lab at the forefront of innovation.

Download the Chain of Custody Program Checklist

A chain of custody (CoC) program ensures the accuracy, reliability, and integrity of your lab. 
Whether you are trying to meet compliance standards or simply wish to standardize your processes, it’s never too late to improve your lab. To help you, we created a free checklist as you set up and implement your chain of custody program. 
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Click the button below to download your free guide.