Leaders in Defensible GxP Data
Every batch you release, every result you file, every signature you rely on is only as good as the data behind it. It takes one shared login, one audit trail nobody reviews, one result quietly overwritten, and the inspection stops being about that record and becomes about all of them. A decade of FDA warning letters has been built on exactly this, and the finding is rarely the failure itself; it is the absence of a system that would have caught it. We build the controls, the governance, and the culture that make your data trustworthy by design and defensible under inspection.
ALCOA+ is the framework every major regulator, the FDA, EMA, MHRA, and PIC/S, uses to decide whether your data can be trusted. It is also the lens we assess your systems through, principle by principle, before an inspector does.
From the first gap assessment to the culture that keeps records clean between inspections, we cover the full span of data integrity and Part 11 compliance.
A system-by-system audit of your data against ALCOA+, with findings ranked critical, major, and minor so remediation starts where the risk is.
Electronic records and signatures assessed against 21 CFR Part 11 and EU Annex 11, with the controls that make them defensible.
A risk-based audit trail review program that actually gets done, not a policy that says it should, so manipulation surfaces before FDA finds it.
Risk-based CSV and CSA that validates the controls data integrity actually depends on, without the paperwork that validates nothing.
Prioritized remediation you can defend: the critical fixes first, the CAPA that closes the finding, and the evidence that it stayed closed.
The data governance program, policies, and training that turn integrity from a document you own into a habit your people keep.
A data integrity assessment is only useful if it finds what an inspector would. We walk your systems the way FDA does: mapping how data is created, changed, and stored; watching the work happen; interviewing the people who do it; and testing whether the controls you documented actually hold. Every finding is ranked critical, major, or minor and tied to a specific ALCOA+ failure, so you get a prioritized remediation plan, not a list of everything that could theoretically go wrong.
Making an electronic record equivalent to a signed piece of paper takes real controls: unique identities, secure and reviewable audit trails, signature manifestations that hold up, and copies you can actually produce. We assess your systems against both 21 CFR Part 11 and EU Annex 11, separate the requirements that genuinely apply from the ones that don't, and specify the controls that make your records defensible on both sides of the Atlantic.
An unreviewed audit trail is worse than none: it proves you could have seen the problem and didn't. Yet reviewing every entry in every system is impossible, so most programs quietly stop. We design audit trail review that is risk-based and actually sustainable, focusing effort on the entries that matter, defining what a reviewer looks for, and building it into the batch-release and periodic-review workflows so it happens by default rather than by heroics.
Too much validation documents everything and assures nothing, burning months to produce paper an inspector never asked for while the data-integrity controls go untested. We run risk-based CSV and Computer Software Assurance the way the guidance actually intends: focus the testing where a failure would corrupt data or a decision, lean on vendor evidence where it is credible, and produce a validation record that proves the controls your data depends on actually function.
Once a data integrity problem is on the record, the response is judged as harshly as the problem. Regulators want to see that you understood the true scope, addressed the highest risks first, and put controls in place so it cannot recur. We build the remediation plan and the CAPA behind it, sequence the work for the biggest risk reduction soonest, and assemble the evidence that turns "we fixed it" into something an investigator can verify.
The companies that pass data integrity inspections are not the ones with the thickest SOPs; they are the ones where doing it right is simply how work gets done. We build the data governance program that gives integrity an owner, clear roles, and real oversight, then deliver the training that makes people understand not just the rule but the reason, so the culture holds up on the day nobody is watching, which is the day it matters.
A regulator already at the door, and a technology landscape moving faster than the rules: each demands more than a standard compliance pass.
A data integrity warning letter, or a consent decree, changes the stakes entirely: independent scrutiny, defined timelines, and a burden of proof that sits with you. We help build the response that regulators actually credit, running the independent data integrity investigation, quantifying true scope across affected products and periods, and standing up the remediation program that has to satisfy a skeptical agency, not just an internal reviewer.
The regulation was written for systems that no longer exist, and now has to govern SaaS platforms, shared cloud infrastructure, and instruments older than the standard itself. We bridge that gap: bringing legacy systems into a defensible state without ripping them out, and assessing modern cloud and vendor platforms so you can adopt them with the audit trails, controls, and vendor evidence that keep them compliant.
Our data integrity leads have sat on both sides of the audit: running quality systems that passed FDA and MHRA inspections, and reviewing data integrity from the regulator's chair. They have written the remediation plan that closed a warning letter and validated the systems that never earned one. You get the practitioner who has done it, not a checklist.
Quality and compliance leaders who have carried GxP systems through FDA, EMA, and MHRA data integrity inspections and lived with the outcome.
Practitioners who have evaluated data integrity from the regulator's side and know which gaps become findings and which findings become warning letters.
Validation and computerized-systems specialists fluent in GAMP 5, CSA, and the platforms that run GxP, from LIMS and MES to cloud QMS.
Leaders who have run data integrity remediation against a regulator's clock, where the plan has to be right and the evidence has to hold.
Tell us where you stand: a proactive assessment, a system to validate, or a finding to remediate. We'll match you with a senior data integrity lead and respond within one business day. All inquiries are strictly confidential.
Our team's perspectives on ALCOA+ in practice, audit trail review that actually happens, and Part 11 in a cloud world: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.
How to make risk-based review real instead of a policy nobody can follow.
The difference between a data integrity finding FDA notes and one it escalates.
Applying a 1997 rule to SaaS platforms without pretending they're the same.