Industries
Laboratories
Contract, QC and nonclinical laboratories generate the data behind regulated decisions. We help laboratory organizations demonstrate that their data is complete, contemporaneous and defensible.
xFDA supports GMP and GLP laboratories with laboratory quality systems, analytical method validation and transfer, instrument qualification, chromatographic data system controls, OOS/OOT investigation practice and data integrity remediation.
How we support this sector
Where engagements typically focus
- Laboratory quality systems for GLP and GMP operations
- Study director and QA unit responsibilities under GLP
- Analytical method validation, transfer and stability programs
- Instrument qualification, calibration and maintenance controls
- Chromatographic data systems, audit trails and access controls
- OOS/OOT investigations and laboratory error prevention
We also support laboratories responding to data integrity findings, including full remediation programs.
When companies call us
Situations we are asked into
- An OOS investigation was closed as laboratory error without supporting evidence.
- Audit trail review is a documented requirement that nobody actually performs.
- A method transfers poorly between sites and no one can explain why.
- Instrument qualification records predate the current software version.
- A data integrity finding requires a defensible remediation program.
Laboratory practice
Laboratories: how we work in this sector
xFDA works inside regulated laboratories — QC, analytical, microbiology and contract — on GMP compliance, data integrity, investigations, method validation and transfer, laboratory quality systems and remediation. This is consulting to improve and repair a laboratory operation, not laboratory sourcing or testing procurement.
Laboratory GMP & quality systems
The system around the analysis: procedures, review practice, qualification, and the records that support a release decision.
- QC laboratory compliance assessment
- Laboratory quality system and procedure redesign
- Second-person review and release practice
- Analyst qualification and competency programs
- Instrument qualification and calibration governance
Data integrity
System configuration, audit trail review and the working culture that determines whether records are complete.
- Data integrity assessment across instruments and systems
- Audit trail review process design and evidence
- User access, permissions and account controls
- Computerised system data lifecycle mapping
- Data governance remediation plans
Investigations: OOS, OOT & CAPA
Investigations that reach an assignable cause and address batch impact rather than closing on a retest.
- OOS/OOT procedure redesign and investigator training
- Retrospective review of closed investigations
- Batch impact and scope assessment practice
- Laboratory CAPA and effectiveness verification
- Trending and recurrence analysis
Methods, transfer & stability
Method work sized to the way the method is actually used in routine operation.
- Analytical method validation strategy and protocol review
- Method transfer protocols and acceptance criteria
- Method lifecycle and revalidation triggers
- Stability program design and management
- Microbiology laboratory compliance
Typical engagements
Laboratory data integrity assessment
System-by-system review of configuration, audit trail practice and review evidence, with a prioritised remediation plan.
QC laboratory compliance review
A working review of procedures, records, qualification and investigation practice, conducted on the bench rather than from the conference room.
Investigation program remediation
Retrospective analysis of closed OOS and CAPA records, corrected procedures, and investigator training that changes how the next one is handled.
This practice is about improving and remediating regulated laboratories. We do not operate a testing marketplace and do not place testing work.
Laboratory GMP & Data Integrity Review
Have a senior laboratory compliance specialist review your QC laboratory: data practices, investigations, method lifecycle and quality system, with findings you can act on.
Expert Answers
Laboratories: answered by our consultants
- What are the most common laboratory data-integrity failures?Unreviewed audit trails, shared analyst logins, and sample or injection sequences that were repeated without a recorded reason. In most cases the underlying cause is a laboratory under schedule pressure with system configuration that permits shortcuts.
- What goes wrong most often in OOS investigations?Retesting before the laboratory phase is complete, invalidating an original result without identifying an assignable cause, and closing the investigation without deciding whether other batches are affected.
- What is the difference between method validation and method transfer?Validation demonstrates that a method is suitable for its intended purpose. Transfer demonstrates that a second laboratory can execute that validated method and obtain equivalent results. They answer different questions, and one does not substitute for the other.
Questions we are asked
Laboratories: common questions
Direct answers from the consultants who do this work.
- What makes an OOS investigation defensible?
- A documented hypothesis-driven laboratory phase performed before any retesting, evidence supporting or excluding laboratory error, a production-phase investigation where laboratory error is not confirmed, and a conclusion that follows from the data. Invalidating a result requires evidence, not a plausible narrative.
- How often should audit trails be reviewed?
- At a frequency justified by risk and documented in procedure — commonly with each batch or analytical record review for GMP-critical data, plus periodic system-level review. What matters is that the review is defined, performed by someone competent and evidenced.
- What does data integrity remediation involve?
- Scoping the affected data and time period, assessing product and decision impact, correcting the technical controls (accounts, privileges, audit trails, backups), fixing the workload or design conditions that drove the behavior, and demonstrating sustained corrected practice.
- Is method validation different from method transfer?
- Yes. Validation demonstrates the method is fit for purpose; transfer demonstrates a second laboratory can execute it to the same standard. Transfers fail most often on equipment differences, sample handling and analyst technique rather than on the method itself.
- Do you support contract laboratories?
- Yes, both contract laboratories building their own quality systems and sponsors qualifying and overseeing them.
Technical guidance for this sector
- Data IntegrityLaboratory data integrity is a question of whether every reported result can be reconstructed from complete, attributable, contemporaneous records.
- GLP ComplianceGood Laboratory Practice under 21 CFR Part 58 governs nonclinical safety studies intended to support applications.
- GMP Laboratory ComplianceA GMP quality control laboratory is judged on laboratory controls: qualified instruments, validated methods, controlled reference standards, complete records and investigations that reach a conclusion.
- Method ValidationMethod validation demonstrates that an analytical procedure is suitable for its intended purpose.
- ANDA SupportGeneric applications are decided as much on manufacturing quality and data credibility as on bioequivalence.
Newsletter
Insights from Former FDA & Industry Experts
Practical perspectives on GMP, quality systems, validation, manufacturing and development — written by the consultants doing the work. No newsletter-only sales pitches.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.