Does FSMA 204 apply to my lab?

FSMA 204 applies to facilities that manufacture, process, pack, or hold foods on the FDA's Food Traceability List. Testing labs aren't directly regulated under the rule — they typically support a client's or facility's recordkeeping rather than holding the compliance obligation themselves.

What's the difference between FSMA 204 and FSMA 201?

FSMA 201 covers supplier verification: you must verify that your ingredient suppliers have safe processes. FSMA 204 covers traceability: you must track where ingredients came from and where they went after you received them.

Can I use a spreadsheet for FSMA 204 compliance?

Technically, yes. The FDA doesn't mandate specific software. Practically, spreadsheets fail at scale. They're slow to search, hard to audit, and vulnerable to accidental changes. If regulators request data within 24 hours and you're hunting through multiple spreadsheets, you're already behind.

What happens if we fail a FSMA 204 audit?

The FDA can issue a warning letter, mandate a corrective action plan, or in severe cases, pursue enforcement action against the facility. More immediately, a failed audit damages customer trust and can result in lost business from major retailers or food manufacturers who require supplier compliance.

How long do I need to keep FSMA 204 records?

Two years minimum. The FDA can audit records older than two years if there's a safety investigation underway, so retention practices matter.

About LabKey Archives

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Posted on September 17, 2026 by Tori Highley

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Posted on September 4, 2026September 4, 2026 by Tori Highley

Clinical Sample Tracking for Labs and Researchers

Posted on September 4, 2026September 4, 2026 by admin

Clinical sample tracking helps scientists and research teams know where samples are in the receiving, storage, testing and analysis process. This allows researchers to quickly identify information regarding the patient/study participant, previous assay runs, derivative samples, storage location, history, and more.

When dealing with human-derived samples, tracking the chain of custody and storing sample-related data in a secure environment is vital. Unfortunately, many research groups are still relying on paper trails for clinical sample tracking due to the low cost and familiarity of the approach. These “paper solutions” are highly error-prone, difficult to scale, and difficult to adapt to increasing complexity in the lab. This can greatly reduce productivity, delay execution of a research study, and can pose regulatory compliance risks. For these reasons, selecting a sample management software designed for clinical sample tracking is critical for success.

When looking for a clinical sample tracking system, consider the following:

Is clinical sample data being stored securely with the proper safeguards to ensure regulatory compliance?
LabKey Sample Manager offers CFR Part 11, HIPAA and FISMA compliant software and hosting, used by leading life science organizations and the FDA. This includes built-in methods to restrict PHI/PII data access, and e-Signing data, managing sensitive data in a secure way is easy and transparent.
Is the sample’s chain of custody captured in the system and easy to retrieve?
Not only does Sample Manager create audit-ready logs for all sample events, we have a unique Sample Timeline that allows users to easily browse a sample-centric chain of custody for auditing and troubleshooting.
Can you customize fields and add built-in validation to ensure correct data entry?
Sample Manager allows administrators to add validators to both numeric and text fields to ensure correct data entry. Quality Control tools allow assay data to be reviewed before it’s shared to ensure that only relevant data is displayed to teams.
Can the clinical sample tracking system provide built-in reporting capabilities that create custom reports unique to your lab’s needs?
LabKey has built-in reporting and charting tools to quickly assess the data, as well as many advanced tools such as built in R and SQL reporting, integrations with Tableau, Spotfire, etc.
Can I capture participant clinical data within the same tool to centralize my data?
LabKey has an extensive study module that integrates with our clinical sample tracking system that allows teams to capture all clinical data. We integrate with REDCap and Medidata RAVE as well. Our study publishing capabilities allow teams to share information with collaborators in a secure way including date-shifted and de-identified data.

Want to learn more about our clinical sample tracking solutions?

>LabKey Sample Manager – product overview and tour

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7 Best Practices for a Successful LIMS Implementation

Posted on September 1, 2026September 1, 2026 by Tori Highley

For researchers, clinical data management and reporting has historically included manual curation and compilation of datasets from disparate data warehouses. In today’s data-rich environment, manual processing and integration is becoming more and more of a bottleneck.

In order to keep up with the increasing amount of data collected from clinical research, clinicians and statisticians alike need software tools that will centralize their data and help them quickly recognize errors. LabKey Server provides essential tools to overcome these, and other key clinical research challenges including:

Maintaining Clinical Data Integrity

Having an accurate representation of clinical data helps transform discoveries and understanding into patient care and treatment. Centrally-housing data in a compliant environment that enforces data standardization can help clinicians maintain excellent data integrity and provide an authoritative view of their data landscape.

LabKey Server helps maintain data integrity by providing:

A highly structured data environment with enforceable data fields to ensure data is entered correctly and within range
Quality control measures such as data flags, QC of datasets and built-in QC reports
Role and group-based permission levels that allow users only access to what they need access to
A compliance module, the allows users to set PHI securities, set Terms of Use for users, and provide electronic signatures on data snapshots

Integration of Data from Multiple Sources

Bringing together data from disparate sources into a single system can help clinical research stay on track and on time. Collaborative monitoring of data quality by clinicians, statisticians, and scientists enables quick identification of erroneous data and ensures a reliable, integrated data landscape for comprehensive data analysis.

LabKey Server helps facilitate comprehensive data integration by providing:

Management of lab data together with clinical data in a single system
A study module that can recognize and integrate disparate vendor datasets
Built-in and customizable integration with electronic data capture systems and case report forms
A clinical document abstraction pipeline, which can extract valuable data from legacy documents

Secure Reporting and Collaboration

A key component of effective clinical data management is the ability to share reports and data with collaborators to improve research, innovation, and ultimately patient care. Maintaining compliance and having the ability to quickly share data and reports is an important topic to tackle in clinical research where patient safety and care is the top priority.

LabKey Server improves reporting and collaboration by providing:

Dynamic and static reporting tables and visualizations that can be shared as-needed
Web-based access to a central platform for data sharing
The ability to remove PHI fields or provide randomized IDs when sharing information with collaborators

With the right tools for clinical data management, research teams can eliminate data integration bottle necks and curate reliable datasets for analysis. Explore our example Longitudinal Study or Sign-up for a free trial to see how LabKey Server can help your team overcome these, and other common clinical research challenges.