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ADVANCED CAPABILITIES · 09 — GXP VALIDATION
Verifiable processes.
GxP (GMP, GLP, GCP, GDP) is the quality framework that requires production data to be reliable and traceable. It asks one question: is it clear who created a record, when and why — and can it be reconstructed? BSS systems answer that with technical infrastructure.
WHAT IS GXP?
Four letters, one principle: the record must be trustworthy.
DATA INTEGRITY · ALCOA+
The ten attributes regulators expect of data.
ALCOA+ is the data integrity framework jointly recognised by the FDA, EMA, MHRA and WHO. Click an attribute to see which technical control in BSS systems supports it.
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IN THE BSS SYSTEM
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AUDIT TRAIL
The history of a transaction can be reconstructed step by step.
Every record is stored with a timestamp, the user and its before-and-after values. A change never hides the original; it is not overwritten but appended alongside.
AUDIT TRAIL
Work Order WO-40218 · change history
immutable record
TIMEACTIONUSER · ROLEBEFORE → AFTERSIGNATURE
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* Sample structure — demo data. Every row is stored immutably with its timestamp, user and previous value.
PRODUCTION HISTORY · BATCH TRACEABILITY
The finished product is traced back to its raw material.
For a dispatched batch, the roll it came from, the work in progress, the stations it passed through and the operators involved all sit in one record chain. When a complaint arrives, the root cause is found in minutes.
BATCH TRAIL
Batch LOT-8842 · Kraft bag 28x16x28 · 320.500 units
dispatched · 15 Aug
#STATION · OPERATIONINPUT · MATERIAL / WORK IN PROGRESSOPERATOROUTPUT
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The chain is complete — input lots, stations and operators all tie to the final batch. Traceback: roll → dispatch, with a single query.
AN HONEST FRAME
Compliance is not something software delivers on its own.
Regulators do not look for the presence of "compliant software features"; they look for the organisation's control, understanding and oversight of its data. BSS provides the technical checks needed for an audit-ready process; the quality system, procedures and training remain the company's responsibility. The system becomes trustworthy when the two work together.
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Note: BSS does not claim to be "certified" against any particular regulation (FDA 21 CFR Part 11, EU GMP Annex 11 and so on). This page describes conceptually which technical capabilities support data integrity principles; the exact compliance scope is defined together in each project.