GMP Consulting Service

Every system that touches GxP data must be validated.

In a GxP environment, every system that creates, processes, or stores regulated data has to stand up to inspection. Entourage delivers risk-based CSV programmes aligned to GAMP 5, 21 CFR Part 11, and EU Annex 11, so your systems are compliant, your data is trustworthy, and your inspections are passed.

Request CSV Assessment → Explore the Challenges

Senior CSV expertise on every engagement. No off-the-shelf templates.

GAMP 5
Risk-Based Validation Framework
GxP
Full GMP, GLP & GCP Coverage
0
Data Integrity Observations at Inspection
On-time
System Go-Live & Validation Closure
The Challenge

Reactive, ad-hoc CSV is no longer defensible.

Pharmaceutical companies operate dozens to hundreds of computerised systems touching GxP data. Without a structured, risk-based validation approach, each system becomes a potential observation: untraceable data, missing audit trails, unvalidated changes, no evidence of testing. Regulators have sharply increased scrutiny of data integrity across all GxP systems, from lab instruments to cloud-hosted SaaS.

01.

No system inventory or risk classification.

GxP-critical systems are undocumented, unclassified, and inconsistently managed across the site.

02.

Data integrity gaps across the audit trail.

Missing, incomplete, or manipulable audit trails are the single most common cause of FDA warning letters and EMA findings.

03.

Cloud, SaaS & vendor-managed systems.

Validation responsibility stays with the pharma company, yet most lack a structured approach for vendor-managed systems.

04.

Uncontrolled changes to validated systems.

Updates, patches, and configuration changes without validated change control compound risk over time.

GAMP 5 Framework

Validation effort scaled to system risk.

We classify every system by GAMP 5 category and criticality, then scale the validation effort to match. No over-validation. No gaps.

Cat 1

Infrastructure

Qualification, not validation. Operating systems, networks, and platforms verified as fit for purpose.

Cat 3

Non-Configured

Off-the-shelf software used as supplied. Standard IQ/OQ against intended use.

Cat 4

Configured

LIMS, MES, ERP and similar. Full IQ/OQ/PQ covering configuration against requirements.

Cat 5

Custom / Bespoke

Custom-developed systems. Full SDLC documentation across the build lifecycle.

AI/ML

Emerging Tech

Adaptive and machine-learning systems. Continuous validation plus change management.

How We Work

A defensible validation lifecycle, end to end.

We execute systematic validation workflows that ensure inspection readiness and system safety at every stage.

01

System Inventory, Risk Classification & Validation Master Plan.

Strategic

Establish complete visibility of every GxP computerised system and a defensible validation rationale.

Operational / Business Impact

Build the full GxP inventory, classify by GAMP 5 category, and author the Validation Master Plan (VMP). Full visibility, defensible rationale, and inspection-ready from day one.

02

Validation Lifecycle Execution.

Strategic

Prove each system is fit for its intended GxP use through documented, traceable testing.

Operational / Business Impact

Execute IQ/OQ/PQ and UAT with URS, FS, DS, configuration specs, protocols, and summary reports scaled to category. Traceable validation packages and no open deviations at go-live.

03

Data Integrity, Audit Trail & 21 CFR Part 11 / Annex 11.

Strategic

Design data integrity into the validated state rather than bolting it on afterwards.

Operational / Business Impact

Run ALCOA+ assessment, audit trail review, access control, e-signature, and backup/recovery as integral protocol components. Zero data integrity observations and demonstrable ALCOA+ compliance.

04

Change Control, Periodic Review & Validated-State Maintenance.

Strategic

Keep systems in a validated state long after go-live and prevent compliance drift.

Operational / Business Impact

Implement change control, periodic review schedules, validated-state registers, and post-validation support. A maintained validated state with no compliance drift between inspections.

Scope of Services

Every GxP system, across the site.

We validate computerised systems across your entire operations, ensuring absolute compliance.

Manufacturing IT

  • MES
  • EBR
  • SCADA / DCS
  • BMS
  • EMS

Laboratory Systems

  • LIMS
  • CDS
  • ELN
  • Standalone instruments
  • Spectroscopy

Enterprise Platforms

  • ERP (SAP, Oracle)
  • QMS / eQMS
  • DMS
  • LMS
  • CAPA / deviation / change modules

Cloud & SaaS

  • Vendor assessment (SOC 2, ISO 27001)
  • Shared-responsibility planning
  • IaaS / PaaS qualification
  • SaaS validation
  • Data migration validation
Regulatory Framework

Built on the standards inspectors apply.

Our validation approaches align directly with the core regulations that auditors look for.

01

GAMP 5 (2nd Ed.)

The risk-based framework for computerised system validation across the GxP lifecycle.

02

21 CFR Part 11

FDA requirements for electronic records and electronic signatures.

03

EU GMP Annex 11

Computerised systems in EU GMP: supplier assessment, backup, and business continuity.

04

FDA / EMA Data Integrity (ALCOA+)

FDA (2018) and EMA (2016) data integrity guidance: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

Case Study

From Warning Letter risk to zero observations in 12 weeks.

A real, anonymised remediation case study showing how structural sequence outperforms ad-hoc actions.

0
Data Integrity Observations at FDA inspection.

Follow-up inspection result after a 12-week remediation cycle.

The Challenge

A mid-size pharma manufacturer faced Warning Letter risk after an FDA inspection found data integrity gaps across multiple GxP systems, with no validated change control and incomplete audit trails. Unvalidated changes had been made to LIMS and MES without impact assessment, audit trails were disabled or incomplete on three critical lab data systems, and there was no GxP inventory, no VMP, and no consistent validation approach.

The Scope

Full GxP inventory across manufacturing, QC, and QA. Risk-based GAMP 5 classification with a prioritised remediation roadmap. Retrospective and prospective validation of LIMS, CDS, MES, QMS, and EBR. ALCOA+ remediation across the affected systems.

The Execution

IQ/OQ/PQ for all priority systems within a 12-week remediation window. Validated change control implemented, with retrospective impact assessments. UAT with key users. Full documentation per system (URS, FS, DS, configuration, plan, summary) and a traceability matrix, with zero open deviations at go-live.

Data Integrity Remediation

Audit trails enabled with formal review procedures. Access control and e-signature validation against 21 CFR Part 11 and Annex 11.

Lifecycle Governance

VMP and GxP register embedded as site governance. First periodic review cycle completed. Training delivered to IT, QA, and system owners.

The Result

The follow-up FDA inspection closed with zero data integrity observations. All systems in a validated state, audit trails operational, and governance embedded in site procedures.

CSV Assessment

Ready to validate with confidence?

Whether you are building a CSV programme from scratch, facing a data integrity finding, preparing for a system implementation, or approaching an inspection, we will assess your validation landscape together.

Wojciech Drzazgowski
Wojciech Drzazgowski
Senior CSV Consultant
Lena Pauli
Lena Pauli
Principal Sales Consultant

Senior CSV expertise on every engagement. No off-the-shelf templates.