Method validation
Each method carries a validation record covering specificity, linearity, range, accuracy, precision, and limits of detection and quantitation. Validation data is available to clients under a confidentiality agreement.
Quality and data integrity
A result is only as good as the record behind it.
Anyone can print a number. What makes it evidence is the method it came from, the instrument that produced it, and whether the record can still be changed afterwards.
Quality system
Built to ISO/IEC 17025
Methods EPL-101 through EPL-104 are in the accreditation process. Every certificate states the accreditation status of the specific method used, on the date it was issued — we do not claim blanket coverage.
System suitability
Every analytical sequence opens with suitability injections. If resolution, tailing, or repeatability fall outside limits, the sequence does not run — the instrument does, and the sample waits.
Reference standards
Quantitation is performed against certified reference material with documented traceability. Standards are logged by lot, stored under controlled conditions, and retired at expiry rather than at convenience.
Independent review
The analyst who produced the data does not release it. A second qualified reviewer checks integration, calculation, and specification before a certificate is signed and published.
Data integrity
Records that cannot be quietly improved.
Data integrity is not a policy statement. It is a set of things the software will not let anyone do.
Audit trails are on and cannot be switched off
The chromatography data system records every acquisition, reprocessing, and integration change with the user and timestamp attached.
Raw data is never overwritten
Reprocessing creates a new version. The original acquisition remains intact and retrievable for the life of the record.
Certificates lock at signature
Once published, a certificate is immutable. A correction is issued as a new certificate that references and supersedes the original, so the revision history stays visible to whoever is reading it.
Retention is measured in years
Instrument data, integration parameters, and calibration records are retained for five years. Certificates themselves resolve permanently.
Chain of custody starts at intake
Samples are barcoded, weighed, and photographed on arrival. Every handoff between storage, preparation, and instrument is logged against that record.
Sample handling
From the courier to the freezer
| Stage | Control | Record kept |
|---|---|---|
| Receipt | Condition check, container integrity, temperature on arrival | Intake photograph, condition note |
| Registration | Barcode assignment against the submission form | Chain-of-custody record |
| Storage | −20 °C and −80 °C with continuous monitoring and alarms | Temperature log |
| Preparation | Calibrated balances, documented diluent lots | Preparation worksheet |
| Analysis | Qualified instruments, system suitability, controls | Instrument audit trail |
| Retention | Remaining material held 90 days from the reported date | Disposal or return record |
If a sample arrives compromised — leaking, thawed, unlabeled, or short of the mass the method needs — you hear from us the same day. We do not run a questionable sample and report the number as if nothing happened.
Ask us for the records.
Validation summaries, control charts, and audit trail extracts are available to clients on request.