[ SYSTEMS & TECHNOLOGY ]

GxP Systems & Technology

The 18 system classes regulated work actually runs on — what each one is, the records it holds, what crosses its boundaries, how it is validated, and what an inspection probes when it is in scope.

This catalog describes system classes, not products. For named commercial platforms, see the software directory.

How to use this library

Start with the domain you work in, then read what each class IS — and, on its page, what it is not, which is where scope failures actually come from. Every number on a card is a live count from the catalog.

A system class is not a product. SPEQ describes what a CTMS or a LIMS is; the vendor directory at /tools lists the products that implement one, and a GAMP category is a property of an implementation, not of a class.

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18 systems

Presentation order

eQMSQualityElectronic Quality Management SystemThe system of record for the quality processes themselves — deviations, CAPA, change control, complaints, audits, and training.10standards5systems it feedsQMSGMPCSV+17 record types

CTMSClinicalClinical Trial Management SystemThe sponsor's operational system of record for trial conduct — sites, milestones, enrolment, monitoring visits, and the oversight trail.6standards4systems it feedsGCPCSVGDocP+16 record types

eTMFClinicalElectronic Trial Master FileThe system of record for a trial's essential records — the filed evidence that lets the conduct of the trial and the integrity of its data be verified.7standards3systems it feedsGCPGDocPCSV7 record types

EDCClinicalElectronic Data CaptureThe clinical database — where site-entered subject data is captured on eCRFs, edit-checked, queried, cleaned, and locked for analysis.8standards3systems it feedsGCPCSVGDocP7 record types

eCOA / ePROClinicalElectronic Clinical Outcome Assessment / Electronic Patient-Reported OutcomeCaptures outcome assessments — patient-, clinician-, and observer-reported — directly from the respondent, on provisioned or personal devices, as source data.7standards3systems it feedsGCPCSVGDocP6 record types

IRT / RTSMClinicalInteractive Response Technology / Randomisation and Trial Supply ManagementRandomises subjects, assigns blinded investigational product, manages depot-to-site supply, and controls emergency unblinding for a trial.7standards4systems it feedsGCPGMPCSV7 record types

Safety / PV DatabaseClinicalPharmacovigilance Database (Safety Database)The pharmacovigilance system of record — where individual case safety reports are processed, assessed, submitted on the regulatory clock, and aggregated.8standards3systems it feedsGVPGCPCSV+17 record types

MES / EBRManufacturingManufacturing Execution System / Electronic Batch RecordExecutes the master batch record on the shop floor and produces the electronic batch record that a batch-release decision rests on.8standards5systems it feedsGMPCSVGDocP+17 record types

Historians, SCADA & PLCAutomation & DataData Historian, Supervisory Control and Data Acquisition, Programmable Logic ControllerThe plant's control and data layer — PLCs execute, SCADA supervises and alarms, and the historian keeps the time-series record of what the process did.9standards4systems it feedsGMPGEPCSV+17 record types

Serialization & Track-and-TraceManufacturingSerialization and Track-and-Trace (unit-level product identification and tracing)Assigns, applies, and verifies the unique identifier on every saleable unit, and exchanges the tracing data that DSCSA and the EU FMD require.7standards3systems it feedsGMPGDPCSV+17 record types

PATManufacturingProcess Analytical TechnologyIn-line and at-line measurement of critical quality attributes during processing — the measurement layer that makes real-time release testing possible.9standards4systems it feedsGMPGEPCSV+16 record types

Continuous Manufacturing SystemsManufacturingContinuous Manufacturing (integrated continuous processing systems)Integrated processing where material flows through connected unit operations without interruption — governed by ICH Q13 and defined by its control strategy.9standards4systems it feedsGMPGEPCSV+17 record types

Digital TwinsAutomation & DataDigital Twin (a synchronised virtual representation of a process, asset, or facility)A process or asset model kept synchronised with its physical counterpart — advisory today, and a regulated system the moment its output informs a GxP decision.7standards4systems it feedsGMPGEPCSV+16 record types

LIMSLaboratoryLaboratory Information Management SystemThe laboratory's system of record for samples, specifications, and results — from login through review to the reportable value a batch decision rests on.9standards4systems it feedsGMPGLPGCLP+27 record types

Lab Instruments & CDSLaboratoryChromatography Data SystemThe analytical instruments and the data systems that acquire and process their signals — where the laboratory's raw data is born, integrated, and reprocessed.9standards3systems it feedsGMPGLPGCLP+26 record types

ERP & Warehouse ManagementEnterpriseEnterprise Resource PlanningThe transactional backbone for materials, batches, and inventory — where batch status physically gates what can be dispensed, picked, and shipped.8standards4systems it feedsGMPGDPCSV+17 record types

RIMEnterpriseRegulatory Information ManagementThe system of record for what is registered where — product licences, submission plans, commitments, and the registered details manufacturing must match.7standards3systems it feedsQMSGMPCSV+16 record types

AI/ML Systems in GxPAutomation & DataArtificial Intelligence / Machine LearningMachine-learning capability embedded in regulated processes — behaviour learned from data, not specified in code, so validation must follow the model.8standards3systems it feedsCSVGMPGVP+17 record types

COMPLETE INDEX — ALL 18 SYSTEM

Every count on this page is derived at render from each system’s standardIds, dataFlows and coreRecords — none is authored as a number.

[ SYSTEMS FABRIC ]

What crosses between these systems

A regulated record set is not held in one place. It is distributed across 18 system classes, and most of the hard questions in an inspection are about the 66 hand-offs between them — which system raised the deviation, which one holds what was actually done, and which one the regulator was told about it in.

The second table is the more useful one. 55 statements of what each system is not the system of record for — the boundaries that stop one platform being believed to own everything.

RECORD FLOWS BETWEEN SYSTEMS (66)
From	To	What crosses
eQMS	MES / EBR	Deviations raised from an in-process exception, and the change control that authorises a master batch record revision
eQMS	LIMS	Out-of-specification and out-of-trend results escalated into a laboratory investigation
eQMS	RIM	Approved changes whose impact assessment concludes a regulatory variation or notification is required
eQMS	ERP & Warehouse Management	Quality holds, batch status decisions, and approved-supplier status that gate material movement
eQMS	Safety / PV Database	Complaints that meet the adverse-event criteria and must be handled as safety cases
CTMS	eTMF	Finalised monitoring visit reports, follow-up letters, and other operational essential records routed to filing
CTMS	IRT / RTSM	Site activation decisions that gate whether a site may randomise subjects and receive investigational product
CTMS	EDC	Site and staff status used to provision, and — on deactivation — retire, access to the clinical database
CTMS	eQMS	Serious breaches and systemic site or vendor issues escalated into deviation and CAPA handling
eTMF	RIM	Final essential records — protocols, approvals, and report appendices — drawn into the clinical modules of a submission dossier
eTMF	CTMS	Completeness and filing-timeliness metrics that feed the sponsor's oversight of sites, CROs, and the trial itself
eTMF	eQMS	Systemic filing failures — a site or vendor whose records are chronically missing or late — escalated as quality events
EDC	Safety / PV Database	SAE data reconciled field-by-field against the safety case, with discrepancies queried back to the site
EDC	CTMS	Enrolment, visit, and data-entry status metrics that feed monitoring triggers and sponsor oversight
EDC	eTMF	Archived casebooks, data-management deliverables, and build documentation filed as essential records at closeout
eCOA / ePRO	EDC	Assessment data integrated into the clinical database by validated transfer, with reconciliation back to the eCOA source
eCOA / ePRO	CTMS	Compliance and completion rates by site, feeding monitoring triggers and oversight of struggling sites
eCOA / ePRO	eTMF	Instrument version records, equivalence documentation, and study-build evidence filed as essential records
IRT / RTSM	EDC	Randomisation numbers and kit identifiers written to the clinical database — never the treatment assignment itself while the trial is blinded
IRT / RTSM	ERP & Warehouse Management	Resupply demand and shipment requests driving physical picking, distribution, and depot inventory movements
IRT / RTSM	CTMS	Screening, randomisation, and enrolment counts by site, feeding oversight and projection
IRT / RTSM	eTMF	End-of-trial randomisation documentation, unblinding logs, and IP accountability records filed as essential records
Safety / PV Database	RIM	Case listings and summary tabulations feeding aggregate safety reports, and the submission tracking of those reports
Safety / PV Database	eQMS	Cases indicating a possible product-quality defect routed into complaint investigation — and complaint-sourced adverse events received back
Safety / PV Database	EDC	Reconciliation output on trial SAEs — discrepancies between the safety case and the clinical database queried back before lock
MES / EBR	eQMS	Execution exceptions that meet the deviation threshold, raised with their batch, step, and equipment context attached
MES / EBR	ERP & Warehouse Management	Material consumption, yield, and batch status that release or hold inventory movements
MES / EBR	LIMS	In-process and finished-product sample requests, with the batch and step identity the result must land against
MES / EBR	Historians, SCADA & PLC	Recipe parameters and phase commands issued down to the control layer for automated steps
MES / EBR	Serialization & Track-and-Trace	Batch, lot, and expiry master data that the packaging lines encode into each unique identifier
Historians, SCADA & PLC	MES / EBR	Process values, phase completion status, and equipment states consumed into the electronic batch record for automated steps
Historians, SCADA & PLC	eQMS	Alarm excursions and cycle failures that cross the deviation threshold, escalated with their time-series context
Historians, SCADA & PLC	Digital Twins	Historical and live time-series data used to build, calibrate, and synchronise process models
Historians, SCADA & PLC	Continuous Manufacturing Systems	Real-time process signals feeding the continuous line's control strategy and residence-time tracking
Serialization & Track-and-Trace	ERP & Warehouse Management	Aggregation hierarchies and unit status that shipping transactions must reference before product moves
Serialization & Track-and-Trace	eQMS	Verification-failure alerts and suspect-product notifications escalated into investigations with statutory timelines
Serialization & Track-and-Trace	MES / EBR	Packaging-line reconciliation counts — commissioned, rejected, sampled, destroyed — consumed into the packaging batch record
PAT	Continuous Manufacturing Systems	Real-time attribute predictions feeding the control strategy — accept, adjust, or divert decisions on flowing material
PAT	MES / EBR	RTRT and in-process results consumed into the electronic batch record as release-supporting evidence
PAT	LIMS	Paired in-process samples and predictions for reference-method comparison during model building and ongoing verification
PAT	Historians, SCADA & PLC	Predicted attribute values written as process tags alongside the measured variables they contextualise
Continuous Manufacturing Systems	MES / EBR	Batch definition, material genealogy, diversion records, and state-of-control summaries assembled into the electronic batch record
Continuous Manufacturing Systems	eQMS	Diversion events and disturbances exceeding the expected envelope, escalated as deviations with their process context
Continuous Manufacturing Systems	LIMS	Samples and data packages for reference testing, stability, and attributes outside the real-time control strategy
Continuous Manufacturing Systems	Digital Twins	High-resolution process data used to build and refine predictive models of the line
Digital Twins	Continuous Manufacturing Systems	Soft-sensor estimates and model-predictive outputs consumed by the continuous line's control strategy
Digital Twins	Historians, SCADA & PLC	Computed and estimated values written back as derived tags alongside the measured data that produced them
Digital Twins	AI/ML Systems in GxP	Training datasets, model artefacts, and performance telemetry exchanged with the ML lifecycle platform for learned components
Digital Twins	eQMS	Model performance excursions and retraining proposals routed into change control and, where warranted, deviation handling
LIMS	Lab Instruments & CDS	Sample identities, test assignments, and worklists pushed to instruments and the chromatography data system for acquisition
LIMS	eQMS	Out-of-specification and out-of-trend results escalated into a formal laboratory investigation
LIMS	MES / EBR	Approved release-testing results and certificate-of-analysis data feeding batch record review and disposition
LIMS	ERP & Warehouse Management	Usage decisions and testing status that move a material or batch between quarantine and released in the inventory system
Lab Instruments & CDS	LIMS	Processed, reviewed results transferred against the sample worklist, with units and significant figures preserved
Lab Instruments & CDS	eQMS	Aberrant-result and audit-trail-review findings escalated into laboratory investigations and data-integrity events
Lab Instruments & CDS	AI/ML Systems in GxP	Historical chromatographic and spectral data supplied as training and monitoring input for anomaly-detection models
ERP & Warehouse Management	MES / EBR	Process orders, bills of material, and batch-managed material identities for dispensing and execution
ERP & Warehouse Management	LIMS	Inspection lots raised at goods receipt and batch creation, triggering sampling and testing against specifications
ERP & Warehouse Management	Serialization & Track-and-Trace	Delivery and shipment events providing the transactional context for aggregation and regulatory reporting
ERP & Warehouse Management	eQMS	Goods-receipt discrepancies and supplier-performance data feeding supplier complaints and requalification
RIM	eQMS	Regulatory impact assessments, per-market approval status, and commitment deadlines gating change-control implementation
RIM	ERP & Warehouse Management	Market authorisation and variation-approval status determining which markets a batch made under a change may ship to
RIM	Safety / PV Database	Product, licence, and market master data underpinning case processing and per-market reporting obligations
AI/ML Systems in GxP	eQMS	Performance degradation and drift alerts raised as quality events, and model changes routed through change control
AI/ML Systems in GxP	Safety / PV Database	Auto-classified and triaged adverse-event cases handed to the safety workflow with confidence context for human review
AI/ML Systems in GxP	MES / EBR	In-line classifications and predictions — inspection results, anomaly flags — surfaced into execution and review-by-exception

BOUNDARIES — WHAT EACH SYSTEM DOES NOT OWN (55)
System	Owned instead by	The boundary
eQMS	MES / EBR	Not the batch record. The eQMS holds the deviation raised against a batch; the electronic batch record holds what was actually done to make it.
eQMS	RIM	Not the regulatory submission system. A change control may conclude that a variation is required, but the variation itself is planned and tracked in RIM.
eQMS	LIMS	Not the laboratory system of record. An out-of-specification result originates in the LIMS or the chromatography data system; the eQMS holds the investigation of it.
CTMS	EDC	Not the clinical database. Subject data — the eCRFs, queries, and locked datasets — lives in the EDC; the CTMS holds the operational status of the sites and visits that produced it.
CTMS	eTMF	Not the trial master file. A monitoring visit report is drafted from CTMS activity, but the finalised, approved report is an essential record and the eTMF is where it is filed and inspected.
CTMS	IRT / RTSM	Not the randomisation or supply system. The CTMS tracks that a site is activated; the IRT enforces whether that site can actually randomise a subject and receive investigational product.
CTMS	Safety / PV Database	Not the safety system. A CTMS may count SAEs for oversight metrics, but the individual case safety report is processed, assessed, and submitted from the pharmacovigilance database.
eTMF	CTMS	Not the operational tracking system. The eTMF files the evidence that a monitoring visit produced; the visit itself — scheduling, findings, follow-up — is managed in the CTMS.
eTMF	RIM	Not the submission publishing system. Essential records may support a marketing application, but the dossier is compiled, published, and tracked in RIM.
EDC	eCOA / ePRO	Not the outcome-assessment platform. Patient- and clinician-reported outcomes are captured in the eCOA system, which holds their source and audit trail; the EDC receives them by validated integration.
EDC	Safety / PV Database	Not the safety case processor. An SAE recorded on an eCRF triggers reporting obligations, but the individual case safety report is built, assessed, and submitted from the pharmacovigilance database, and the two are reconciled.
eCOA / ePRO	EDC	Not the clinical database. Assessment data flows into the EDC by validated integration, but the eCOA system holds the source record and its audit trail — the EDC copy is downstream, and reconciliation runs between the two.
eCOA / ePRO	Safety / PV Database	Not the safety intake channel. An alarming response can trigger an alert to the site, but the clinical assessment of the subject and the processing of any resulting case belong to the site and the pharmacovigilance system.
IRT / RTSM	EDC	Not the clinical database. The IRT records the randomisation transaction and kit assignment; the subject's clinical data lives in the EDC, which receives the randomisation number — never the treatment arm — by integration.
IRT / RTSM	ERP & Warehouse Management	Not the warehouse or ERP. Physical inventory, GMP batch status, and release of investigational product are owned by manufacturing and distribution systems; the IRT holds the trial's logical view of kits and drives demand against it.
IRT / RTSM	Safety / PV Database	Not the safety system. Emergency unblinding is executed through the IRT, but the clinical event that prompted it is assessed by the investigator and processed through pharmacovigilance workflows.
Safety / PV Database	EDC	Not the clinical database. An SAE captured on an eCRF is clinical data; the safety case built from it is a separate record of record in the PV database, and the two are reconciled field by field before database lock.
Safety / PV Database	eQMS	Not the complaint system. A product-quality complaint lives in the eQMS; when a complaint carries an adverse event — or a case suggests a quality defect — the record must flow both ways, and the interface between the two is a classic inspection probe.
Safety / PV Database	RIM	Not the aggregate-report author. PBRERs and PSURs draw their case listings and summary tabulations from the database, but the documents are authored, reviewed, and submission-tracked outside it.
MES / EBR	eQMS	Not the quality-event system. The MES flags the exception; the deviation raised from it, the investigation, and the CAPA live in the eQMS.
MES / EBR	ERP & Warehouse Management	Not the ERP. Inventory valuation, procurement, planning, and the financial view of a batch belong to Level 4; the MES consumes material lots and reports back what was used.
MES / EBR	Historians, SCADA & PLC	Not the raw process-data archive. Second-by-second process values live in the historian; the EBR carries the values and summaries the batch record requires, not the full time series.
MES / EBR	LIMS	Not the laboratory system of record. The MES requests an in-process sample and consumes the result status; the analytical record itself belongs to the LIMS.
Historians, SCADA & PLC	MES / EBR	Not the execution layer. The MES orders the phase and records the batch context; the PLC runs it. Recipe enforcement and operator signatures belong one level up.
Historians, SCADA & PLC	MES / EBR	Not the batch record. The historian holds everything the process did; the EBR holds what the batch record requires. A trend supports an investigation — it does not substitute for the reviewed record.
Historians, SCADA & PLC	PAT	Not the analytical measurement layer. PAT analysers and their chemometric models are a distinct system class, even when their outputs land in the historian as tags.
Historians, SCADA & PLC	Digital Twins	Not a model. The historian records what happened; a digital twin predicts what will. Feeding one from the other does not merge their obligations.
Serialization & Track-and-Trace	ERP & Warehouse Management	Not the inventory system. The ERP owns stock, orders, and shipment planning; serialization owns the identity and status of each unit inside those movements.
Serialization & Track-and-Trace	MES / EBR	Not the batch record. The EBR proves the batch was made and packaged as intended; serialization proves which identified units that batch became and where they went.
PAT	LIMS	Not the QC laboratory. The LIMS owns the reference methods, specifications, and release results; PAT measures in the stream and must be reconciled to the lab, not substituted for it by assertion.
PAT	Historians, SCADA & PLC	Not the control system. PAT measures and predicts; the decision to adjust or divert is executed by the control layer acting on those signals.
PAT	Lab Instruments & CDS	Not the chromatography data system. CDS instruments run the laboratory's reference and release methods; a PAT analyser lives in the process with a fundamentally different qualification context.
PAT	Digital Twins	Not a digital twin. A chemometric model converts today's spectrum into today's attribute; a twin simulates the process itself. The two can cooperate, but their claims and validation differ.
Continuous Manufacturing Systems	MES / EBR	Not the batch record system. The continuous line generates diversion, tracking, and state-of-control data; the electronic batch record that assembles it into a releasable record lives in the MES.
Continuous Manufacturing Systems	PAT	Not the measurement layer. PAT analysers and their chemometric models are their own system class; the continuous line is their most demanding customer, not their owner.
Continuous Manufacturing Systems	Historians, SCADA & PLC	Not just the control layer. PLCs and SCADA run the equipment; the continuous-manufacturing system adds material tracking, RTD-based diversion logic, and batch definition on top of them.
Continuous Manufacturing Systems	Digital Twins	Not a process model in itself. RTD and control models serve the line, but a predictive twin of the process is a distinct class with distinct validation claims.
Digital Twins	Historians, SCADA & PLC	Not the historian. The historian records what the plant did; the twin estimates and predicts. Feeding the twin from historised data does not make the two interchangeable as evidence.
Digital Twins	PAT	Not the PAT layer. A chemometric model converts a measured spectrum into an attribute; a twin models the process itself and may estimate states no instrument measures. Their validation frameworks differ accordingly.
Digital Twins	AI/ML Systems in GxP	Not the ML platform. Where a twin embeds machine-learned components, the model development and lifecycle tooling belong to the AI/ML system class; the twin is the consumer of those artefacts.
LIMS	Lab Instruments & CDS	Not the raw-data system. The chromatogram and its integration live in the chromatography data system; the LIMS holds the reportable result derived from them.
LIMS	eQMS	Not where the OOS investigation lives. The LIMS flags the out-of-specification result; the investigation, its root cause, and any CAPA are quality records in the eQMS.
LIMS	ERP & Warehouse Management	Not the inventory system. The LIMS tracks samples and reagents for testing purposes; material stock, batch status, and warehouse movements are ERP records.
Lab Instruments & CDS	LIMS	Not the sample's system of record. Sample lifecycle, specifications, and the reportable result live in the LIMS; this class produces and processes the raw data behind that result.
Lab Instruments & CDS	Historians, SCADA & PLC	Not the process historian. In-line process instrumentation and its time-series data belong to the automation layer; this class is the analytical laboratory's measurement estate.
Lab Instruments & CDS	eQMS	Not where an aberrant result is investigated. Reprocessing history is evidence for the investigation, but the investigation itself is a quality record in the eQMS.
ERP & Warehouse Management	MES / EBR	Not the batch record. The ERP knows a process order exists and what it consumed; the electronic batch record holds the evidence of how the batch was actually made.
ERP & Warehouse Management	eQMS	Not where the release decision is made. Quality decides disposition in its own records; the ERP executes the resulting status change and gates transactions on it.
ERP & Warehouse Management	Serialization & Track-and-Trace	Not the serialisation repository. Serial number generation, aggregation, and regulatory reporting events belong to the dedicated serialisation layer, exchanging shipment context with the ERP.
RIM	eQMS	Not the change control system. The change is assessed and approved in the eQMS; RIM plans and tracks the regulatory actions the change requires per market, and holds the approval status each market returns.
RIM	Safety / PV Database	Not the safety system. Pharmacovigilance cases, signal management, and expedited reporting run in the safety database; RIM supplies the product and licence facts those processes depend on.
RIM	eTMF	Not the clinical trial master file. Trial conduct records belong to the eTMF; RIM tracks the applications and authorisations surrounding the trial, not its execution evidence.
AI/ML Systems in GxP	Digital Twins	Not the digital twin. A twin is typically a mechanistic or hybrid simulation of a physical process; ML models may feed it, but the twin's claim rests on process understanding, not learned classification.
AI/ML Systems in GxP	PAT	Not the measurement layer. PAT instruments and their chemometric models produce the in-process signal; this class covers learned models consuming such data to classify, predict, or decide.
AI/ML Systems in GxP	Historians, SCADA & PLC	Not conventional automation. PLC logic, SCADA, and historians execute and record deterministic, specified behaviour; the distinct obligations here begin where behaviour is learned rather than programmed.

These are system CLASSES, not vendor products, and the flows describe how the classes conventionally divide the record set rather than how any particular site has integrated them. SPEQ models the relationships; the records themselves stay in the systems that own them.

[ HOW THE FABRIC FAILS ]

Where the joins actually give way

This catalog describes system classes as designed. The Systems and Data Fabric describes how a landscape behaves — when each interface transfers and how it fails, what each control does not prove, what a role cannot do and the shortcut that defeats it, where the authoritative copy of each evidence category lives, and what happens when a system is simply unavailable. It works a synthetic site spanning utilities, process equipment and computerised systems, so it covers the two kinds this catalog does not.

Open the Systems and Data Fabric →