en - CSV CSG

CSG CSV

Computerized System Validation Consulting Services Group

CSV CSG (Computerized System Validation Consulting Services Group) is your trusted partner for driving digital transformation in the

Pharma

Biotech

Medtech

sectors. Our mission is to ensure your business and production processes, along with associated computerized systems, maintain strict compliance and GxP conformity.

With our specialized consulting approach utilizing CSV^apt® and comprehensive training via our dedicated portal CSVAcademy, we empower your team to navigate complex regulatory landscapes seamlessly. Partner with CSV CSG today for sustainable, reliable, and continually validated systems that propel your organization forward in the evolving life science industry.

Digital Transformation

Transformation is an ever-evolving journey that needs to seamlessly integrate with your current business and production protocols. Therefore, any digital transformation, with its innovative processes, necessitates thorough planning and preparation. A tailored digital transformation strategy becomes imperative.

The execution of this strategy demands continuous evaluation to ensure its alignment with existing processes, preserving their integrity and efficacy. This is crucial for upholding

1. patient safety
2. product quality
3. data integrity

thereby ensuring compliance and GxP adherence. This responsibility extends across your entire organization, involving not only the management team but also department heads and every employee, whether directly or indirectly engaged in compliance efforts.

is the product of the CSV Consulting Service Group, with which the digital transformation finds its way into your company and makes it fit for the future.

CSV: Computerized System Validation

Adapted: according to the risk-based approach

Precise: with critical thinking

Tailormade: with AI/LM (artificial intelligence / learning machines)

for your company, in the ongoing business and production processes.

With the CSVAcademy, we train your employees in CSV according to GAMP^® 5 in the 2nd edition to prepare for digital transformation and implement it in your company. CSV CSG offers 4 modules:

Module 1: The world of CSV

We train basic CSV knowledge about compliance and validation in the regulated environment with all directives, norms, standards, and guidelines.

Module 2: GAMP^® 5 SDLC

GAMP^® 5 is an international guideline in the life science industries, published by the ISPE^® (International Society for Pharmaceutical Engineering). We teach the complete SDLC (System Development Life Cycle) including iterative procedures. We also address the new topics of the 2nd edition, such as critical thinking, artificial intelligence / machine learning, and Pharma 4.0.

Module 3: CSV Specialist

Your suppliers, external service providers, and subcontractors are your company’s extended workbench. This module shows you how to integrate them into your company effectively and efficiently, as expected by the regulatory authorities and notified bodies.

Module 4: CSV Auditor

In this module, we teach you how to plan, carry out, and document audits so that you can conduct internal audits in your company or external audits, e.g. with prospective external service providers.

The modules can be booked individually, divided into subject areas, or as a bundle of several modules.

Audits

CSV CSG conducts audits in the area of CSV, GAMP^® 5 in the 2nd edition, and ISMS (Information Security Management Systems). This includes the preparation, execution, and follow-up (audit report, recommendations, and CAPAs), whether it is internal audits, mock audits, external audits for the assessment of external providers, or generally to prepare your employees for situations during audits and inspections by regulatory authorities or notified bodies.