What is gxp compliance is a phrase that gets searched by two people: the one who wants a definition for a memo and the one who has to sign an attestation about it next quarter. This page is written for the second. For a pharma, biotech or laboratory business under good practice rules, what is gxp compliance comes down to a record and a set of figures: the record is the validated systems, the SOPs, the training records, the deviations and the CAPAs, kept with an owner, a date and a status; the figures are the evidence load that record puts on its reviewers, the days an audit of it takes, the gaps an audit will find and what they cost, the incidents and cases it produces, and the training it requires. The sections below explain what is gxp compliance in those terms, say what it is not, and show where the free sheets on this site work each figure from the programme's own numbers with no account.
Why the search is what is gxp compliance
The words in what is gxp compliance are the words a pharma, biotech or laboratory business under good practice rules uses when the obligation has a name and the programme does not yet have a number. The name is the regulator's, linked below; the number is the programme's own, and it is the count of obligations, controls and evidence items behind GxP turned into reviewer hours on the obligations register sheet and into audit days on the audit scope sheet. A programme that searches what is gxp compliance and comes away with those two figures has done the first day of the work, and the paid plan on this site keeps what follows: the record, with owners, dates and the attestation that closes each period.
What what is gxp compliance means in practice
For a pharma, biotech or laboratory business under good practice rules, it means being able to show, for each obligation, which control satisfies it, what evidence proves the control operated, who reviewed the evidence and who attested to the result. The record is the validated systems, the SOPs, the training records, the deviations and the CAPAs. The regulator's own material, linked below, says what the obligations are; this site publishes none of that and no legal advice. What it publishes is the arithmetic: the obligations register sheet turns the count of obligations, controls and evidence items into reviewer hours and the months to a full attestation.
The figures behind what is gxp compliance
Evidence items and reviewer hours; audit samples, days and coverage; expected gaps, remediation hours and cost; incident hours; case backlog months; training seats outstanding. Each is a free sheet on this site and each computes from the programme's own inputs. For GxP the sheet to start with is the IT control-testing sheet, which works the figure a pharma, biotech or laboratory business under good practice rules is examined on first. A programme that knows those numbers has stopped estimating its own compliance.
What what is gxp compliance is not
It is not a certificate, a piece of software or a consultant's memo, although all three are sold under the name. It is a record and the figures that follow from it, kept by the business that owes the obligations. The guide this page supports covers sizing compliance management consulting from the audit scope, the help a small business buys around that record. Attestvio Pro keeps the record at one flat price; the sheets are free with no account.
Questions people ask about what is gxp compliance
What is what is gxp compliance?
For a pharma, biotech or laboratory business under good practice rules: keeping the validated systems, the SOPs, the training records, the deviations and the CAPAs as a record with an owner, a date and a status, and being able to show for each obligation the control, the evidence and the attestation. The regulator's own material, linked below, defines the obligations; the free sheets on this site work the arithmetic.
Who is responsible for what is gxp compliance in a small business?
The compliance officer, or the owner wearing that hat, who signs the attestation. The sheets on this site are written for that person and need no account.
Does Attestvio make a business compliant with GxP?
No. The business meets the obligations; Attestvio keeps the record and works the figures, and publishes no rule and no advice. Counsel and the regulator's own material say what the obligations are.