November 11, 2026
About LabKey
An environmental LIMS supports NELAP/TNI and ISO 17025 audits by keeping an audit trail of every change to a result and by controlling who can make those changes. When an assessor picks a result and asks how it was produced and whether anyone altered it, the LIMS should be able to answer from its own records.
How do ISO 17025 and TNI relate?
ISO 17025 is the international standard for the competence of testing and calibration laboratories. TNI, The NELAC Institute, runs NELAP, the National Environmental Laboratory Accreditation Program. They publish the laboratory standard that its accreditation bodies use to accredit environmental labs in the U.S. The 2016 edition is the current one, though each accreditation body decides which edition it applies.
The TNI standard carries the ISO 17025 text and adds TNI’s own requirements for environmental testing. One of those additions is a documented data integrity system.
Why audit-ready records matter to environmental labs
Environmental data feeds decisions with legal and financial consequences. A discharge monitoring report and a drinking water compliance decision each rest on a lab result that someone may later challenge.
Commercial labs feel this directly. Their clients, such as consulting firms and utilities, use the lab’s results in their own regulatory submissions. When a regulator questions a result, the lab has to show how it was produced and that nobody altered it afterward.
Accreditation is how a lab demonstrates that. Under NELAP, assessors from the lab’s accreditation body review its records and quality system, and what they find affects whether the lab keeps the accreditation its clients rely on.
The 2016 TNI standard also addresses what a lab does when it suspects a data integrity problem: it investigates and documents what happened. That work depends on records that show who changed what, and when.
A spreadsheet has no built-in way to require a reason for each change to a result.
What do assessors look for in electronic records?
ISO 17025:2017 requires that amendments to technical records can be traced to the original observation. Both the original and the amended data stay on file, along with the date, what changed, and who made the change. An assessor can pick any result and ask for that history. The table pairs each expectation with what LIMS software should do and what an assessor can ask to see.
| Expectation | What a LIMS should do | What an assessor can ask to see |
|---|---|---|
| Traceable edits | Capture every change to a result with who made it, when, what changed, and the previous value. Require a reason for each change. | The change history of any result the assessor selects. |
| Original records preserved | Keep the original value when a record is amended, so both versions stay retrievable. | The original and amended values of the same result, side by side. |
| Periodic data review | Let the lab query the audit trail by date range or by record, and export it in full. | Every change to results over a chosen period, such as the last quarter. |
| Controlled access | Limit by role who can enter, edit, or approve records. | Who holds edit rights, and what each role permits. |
| Documented review | Record sign-off with electronic signatures on method and analysis notes, including who signed and when. | The signed entries for a given analysis. |
| Result-to-sample link | Tie every result to the sample it came from. | A trace from a reported result back to its sample record (chain of custody). |
How LabKey LIMS keeps your records ready for an assessor
When an assessor picks a result, LabKey LIMS shows its full history: who changed it, when, the previous value, and the reason. You open the audit trail and read it.
- A reason for every change: the audit trail requires one before an edit saves, and it captures the previous value.
- Review on your schedule: query the audit trail by date range or by record, and export all of it.
- Read-only access for auditors: an assessor reviews the records directly, and nobody else’s work changes while they do.
- Edit rights that match job roles: role-based access controls who can enter and edit.
- Signed notebook entries: ELN entries carry electronic signatures.
- A system that follows your methods: change a metadata field or workflow when a method changes, without code.
When a client or regulator questions a result, the history is already there, living in your LIMS software.
What should you ask a LIMS vendor about audit trails?
Ask these questions before you commit to a LIMS vendor for an accredited lab, and ask to see each answer in the software.
- Can you show me the audit trail for a single result, including the previous value and the reason for the change?
- Is a reason required before a user can save an edit?
- Can I query the audit trail by date range and by record, and export all of it without the vendor’s help?
- Can I limit by role who enters, edits, and approves results?
- Can I give an assessor read-only access to the records?
Common questions about LIMS and NELAP/TNI audits
No. ISO 17025 sets requirements for technical records and for the control of data and information systems, and a lab can meet them on paper or electronically.
The 2016 TNI standard requires a lab to maintain a documented data integrity system, and to investigate and document suspected data integrity problems.
No. Accreditation is granted to the lab. An accreditation body assesses the lab against the standard, and a LIMS is one of the systems the lab can use to support the record requirements.
A LIMS supplies the records. The lab still writes its data integrity procedures and trains its staff on them. An audit trail makes periodic data review practical, and someone on the lab’s team still has to do the reviewing.