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.

GxP traceability flow — the audit trail across laboratory, production, quality control and distribution

WHAT IS GXP?

Four letters, one principle: the record must be trustworthy.

GMP

Good Manufacturing Practice

Production and quality records: batch records, equipment calibration, quality control results.

GLP

Good Laboratory Practice

Laboratory and test records: analysis, measurement and validation data.

GCP

Good Clinical Practice

Clinical study data and study records; the most tightly audited area.

GDP

Good Distribution / Documentation

Distribution and documentation: how records are produced, retained and retrieved.

DATA INTEGRITY · ALCOA+

The ten attributes regulators expect of data.

ALCOA+ is the data integrity framework jointly recognized by the FDA, EMA, MHRA and WHO. Click an attribute to see which technical control in BSS systems supports it.

A · Attributable

Attributable

It must be clear who created each record and through which action.

IN THE BSS SYSTEM

Every action is tied to the signed-in user and their role; no anonymous records form.

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
08:12:04 Work order createdChromo board 350 g 700×1000 · status: draft M. DemirPlanner — system
08:15:37 Target quantity changedprevious value retained A. YıldızPlanner 19,00019,500 record
08:16:02 Approved and releasedstatus: draft → active Planning Mgr.Executive draftactive e-signature
11:03:18 Output counter readlive from the floor · 8,463 sheets/h BSS AutomationSystem — automatic
13:47:55 Downtime reason entereddie change · 12 min S. KayaOperator — record
* 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.

Finished goods on the conveyor — traceability from raw material to dispatch
BATCH TRAIL Batch LOT-8842 · Kraft bag 28x16x28 · 320,500 units dispatched · Aug 15
#STATION · OPERATIONINPUT · MATERIAL / WORK IN PROGRESSOPERATOROUTPUT
01 Reel WarehouseMaterial issue Kraft liner 90 g · 1400 mmRM-BOB-3391 Warehouse · R. Ateş 15 reels
02 Flexo Printing · W&H Miraflex II4 colors + varnish Ink set + printing plateYM-BSK-5512 M. Demir 330,000 sheets
03 Lamination · L6Cellophane coating Printed sheet + filmYM-LAM-5518 E. Çetin 328,000 sheets
04 Die-cut · Bobst 145Die-cutting Laminated sheetYM-KES-5524 S. Kaya 325,000 cuts
05 Gluing · Omega 165Bag blank + handle Cut blank + handle cordYM-YAP-5531 H. Acar 322,000 units
06 Packing & PalletCarton + pallet strapping Finished bag + cartonFG-LOT-8842 Dispatch · T. Öz 320,500 units
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 organization'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.

What BSS provides — technical controls

  • Immutable audit trail and timestamping
  • Role-based access and electronic signature
  • Centralized, backed-up and versioned records
  • Query and export within seconds

The company's responsibility — the quality system

  • Procedures, SOPs and data governance
  • User training and permission definition
  • A routine for reviewing the audit trail
  • Risk-based validation (IQ / OQ / PQ)

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.

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