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Entourage

Area of expertise

Quality Management & Compliance

A quality system is judged in the inspection, not in the manual. We build and remediate QM systems under ISO 13485 and the EU GMP Guide, prepare for FDA and EMA inspections and close the most common sources of findings: CAPA and deviation management, computer system validation and data integrity under Annex 11 and 21 CFR Part 11, process validation and audit readiness.

  • Biotech
  • IVD
  • MedTech
  • Pharma

All topics

24 topics in Quality Management & Compliance

21 CFR Part 11 (FDA, Electronic Records; Electronic Signatures)

21 CFR Part 11 & Data Integrity →

Consulting on 21 CFR Part 11 and data integrity for GxP-regulated pharma, biotech, MedTech and IVD systems: Part 11 gap analysis, ALCOA+ data integrity audit, audit trail and e-signature design, plus GxP IT supplier assessment, aligned with EU GMP Guide Annex 11 and validation in line with GAMP 5.

EU-GMP Guide Annex 1 (Manufacture of Sterile Medicinal Products, Revision 2022)

Annex 1 (Sterile Manufacturing) →

Annex 1 consulting for sterile manufacturing: building and implementing the Contamination Control Strategy (CCS), gap analysis against the revised EU-GMP Annex 1, RABS and isolator strategies, aseptic process simulation (media fill) and inspection readiness, risk-based in line with ICH Q9.

ICH Q10 (Pharmaceutical Quality System), Corrective Action and Preventive Action (CAPA) System

CAPA Management →

Building and remediating CAPA systems for Pharma, Biotech, MedTech and IVD: structured root-cause analysis, scheduled action planning, effectiveness verification and backlog clearance in line with ICH Q10, EU GMP Guide Part I, 21 CFR Part 820 and ISO 13485:2016.

ISO 14644-1 (classification of air cleanliness by particle concentration)

Cleanroom Qualification →

Cleanroom qualification for regulated production: classification and HVAC concept, IQ/OQ/PQ to ISO 14644-1 and ISO 14644-2, setup and validation of environmental monitoring, and requalification, embedded in the contamination control strategy under EU GMP Guide Annex 1.

EU 2017/745 (MDR)

Complaint Management →

Complaint management consulting for pharma, biotech, MedTech and IVD: process setup in line with ISO 13485:2016 clause 8.2.2, coupling to the vigilance reporting obligation under MDR (EU 2017/745), systematic trending for early signal detection, and the remediation of open complaint backlogs with complete investigation documentation.

EU-GMP-Leitfaden Annex 11 (Computerised Systems)

Computer System Validation (CSV) →

Computer system validation for regulated IT systems: risk-based classification under GAMP 5, a complete validation package from URS to PQ, data integrity and audit trail under EU GMP Annex 11 and FDA 21 CFR Part 11, and change control and revalidation across the lifecycle - for LIMS, ERP, MES, eQMS and control systems.

ISO 13485:2016 (QM system for medical devices, management review)

Continuous Improvement Programs →

Continuous improvement consulting for life sciences: building CIP systems with idea management, prioritization and KPI-based performance measurement, Kaizen and rapid improvement workshops, training of internal CIP coaches and integration into management reviews under ISO 13485:2016 as well as into the change control system in the GMP environment.

ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)

Data Integrity Assurance →

Data integrity consulting in line with ALCOA+ for manufacturers in pharma, biotech, MedTech & IVD: gap analysis of critical GxP data systems, audit trail review in LIMS, MES and chromatography systems, data integrity procedures and training, plus remediation following inspection findings, aligned with PIC/S PI 041, the EU GMP Guide Annex 11 and 21 CFR Part 11.

EU GMP Guide (EudraLex Volume 4)

Deviation Management →

Deviation management for pharma, biotech, medtech and IVD: system design and SOP in line with EU GMP (EudraLex Volume 4) and ICH Q10, structured root cause analysis, OOS investigation process, clearing deviation backlogs and embedding the process in the quality management system.

Next step

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  • 100% life sciences
  • 500+ projects completed
  • Reply usually within one working day

Case Studies

Projects in this area

All case studies →
Case StudyPharma

Annex 1 Compliance in Sterile Manufacturing

An international pharmaceutical company specializing in sterile products had to align its processes and systems with the new requirements of Annex 1 of the EU GMP Guidelines.

International pharmaceutical company for sterile products

Case StudyPharma

Audit Software Integration for Improved Production Quality under GMP

An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor production processes in line with GMP and reduce regulatory risk.

International software provider in the regulated life sciences environment

Case StudyPharma

Audit Support: Securing Reliable Audit Results

Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.

Life sciences company with its own internal and external value chain

Insights

Current articles

All insights →
Article

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

ISPE GAMP 5 (2nd Edition, 2022)

Article

AI-Driven Inventory Optimisation: Consolidating Redundant Stock Without Touching the ERP

In pharma and MedTech warehouses, duplicated, technically identical items tie up capital and space without showing up in the ERP. How feature-based consolidation with AI makes redundant stock visible, without any intervention in the validated system.

EU GMP Guidelines Annex 11 (Computerised Systems)

Whitepaper

MDR Meets the EU AI Act: The Trilemma for AI Software

AI software that qualifies as a medical device must satisfy the MDR and the EU AI Act at the same time. The costly mistake is not the second regulation, but running two separate worlds of documentation. Where MDR classification and AI Act high-risk status interlock.

Regulation (EU) 2024/1689 (EU AI Act)

Other areas

Product Development & Regulatory Strategy

From classification and regulatory strategy through to development and study planning.

Market Access, RWE & Reimbursement

Market access, health economics, real-world evidence and pricing and reimbursement strategy.

Regulatory Affairs

Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.

Supply Chain & Technical Operations

Supply chain, manufacturing, shortage management and technical operations optimization.

Your project

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info@theentourage.it

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  • 4 offices: DE · CH · IT · US
  • 100% life sciences