What sits behind a lims database: why the schema is the vendor's rather than yours, what read access to it is worth and what writing to it destroys, how laboratory information management system lims software handles versions and archives, and where iso 17025 software obligations land in the data

What to ask about the data layer

1. Ask for read access, and expect it through a view or an API. A read-only view or a documented interface gives you your data for analysis without exposing the internal schema you would then depend on. A vendor unwilling to provide any read route is a vendor whose data you cannot analyse, which is a real cost over a decade.
2. Never write directly to the tables. Direct writes bypass validation, the audit trail and any business logic the application enforces, which means the record no longer reflects what the system believes happened. In a regulated laboratory that is a data integrity finding; in any laboratory it is a corruption waiting to be discovered.
3. Establish how the audit trail is stored and whether it can be read. The audit trail is the part of the record an inspector reads, and its usefulness depends on whether it can be queried rather than only displayed a row at a time. Ask to see an audit trail extract for a real change.
4. Ask what happens to old data on upgrade and on archive. Schemas change between major versions, and archived data that can only be read by a retired version is data you have lost. Ask specifically how historical records are migrated and whether an archive remains queryable.
5. Confirm the export before you sign. A full export including the audit trail in an open format, tested during the evaluation, is the single most useful hour of a software trial. It decides whether you can ever leave, and therefore what every renewal conversation looks like.

Reporting against a copy rather than the live system

A nightly extract into a reporting store gives analysts freedom without putting query load on the system the laboratory depends on. It costs a little freshness and removes both the performance risk and the temptation to query production directly.

Define the extract's contents and its refresh with the people who will use it. An extract that omits the field somebody needs gets worked around, usually by asking for the access this page warns against.

Validation and the data layer

Where the work is regulated, the system is validated for its intended use and the validation covers the data it holds. A change to the data outside the application is a change outside the validated state, which is why direct writes are a finding rather than a shortcut.

Keep the validation documentation current through upgrades. A system validated at go-live and upgraded twice since is, on paper, an unvalidated system holding regulated records.

Common questions

Should I have direct access to the lims database?

Read access, yes, ideally through a documented view or interface. Write access, no: direct writes bypass validation, business logic and the audit trail, and leave a record that does not describe what the system thinks happened.

Who owns the schema?

The vendor, in practice, and it changes between versions. That is why analysis should run against a stable view or an interface rather than against the internal tables, which can be reshaped by an upgrade without warning.

What does the audit trail have to do?

Record who changed what, when and why, be protected from alteration, and be readable. Under 21 CFR Part 11 it also has to be reviewed rather than merely enabled, which means it has to be queryable in practice.

How do I get my data out at the end?

Test the export during the trial, including the audit trail, in an open format. An export that turns out to be a set of screen reports is not an export, and discovering that at the end of a contract is the worst moment to discover it.

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