See what a validation package looks like when it builds itself
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demoALCOA+ is a set of principles regulators use to judge whether a GxP record can be trusted. The letters stand for attributable, legible, contemporaneous, original, and accurate, with complete, consistent, enduring, and available added on as the plus.
Attributable means a record shows who created or changed it. Legible means it can actually be read, by a person and often by a system, years later. Contemporaneous means it was recorded at the time the activity happened, not reconstructed afterward from memory. Original means it is the first capture of the data, not a copy someone typed up later. Accurate means it reflects what actually happened.
Complete means nothing relevant was left out, including failed attempts and repeat tests. Consistent means the sequence of events makes sense and timestamps line up. Enduring means the record survives for as long as it is required to, not just until someone's laptop gets replaced. Available means it can be retrieved and reviewed when someone, an auditor included, needs to see it.
Excel is the usual offender. A spreadsheet with no audit trail, editable by anyone with the file, saved over the previous version, fails attributable and original almost by design, no matter how carefully someone fills it in. The problem is rarely the person. It is the tool having no structural way to enforce these nine principles.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
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