Computerized System Validation for your company
adapted - precise - tailormade
provided by internet training and internet consulting
Transfer of know-how into your company will be facilitated, minimizing costs for you, and allowing more time explicitly dedicated to training and consulting for your employees.

as interim assignment with short and fast onboarding
for smooth takeover and continuation
of the CSV task
Thomas W. Hoehle

Dipl.-Ing. Thomas W. Höhle

The engineering company® has been providing consulting and training services to pharmaceutical, biotech, and medtech companies since 2004 in the areas of software testing, test management, and quality management. Since 2011, they have also been specializing in Computerized System Validation (CSV) and Compliance,
with all services digitized.

Here are 3 things our customers compliment us:
  • Maximum service: We identify with the companies we train and consult, ensuring compliance.
  • Individual costumized strategy with integrating techniques (IT): We commit ourselfves to the customer and work together to implement the agreed strategy, aided by our service product CSVapt®!
  • Go the extra mileWe are available for our customers at any time, and we can perform tasks such as software tests outside of ordinary business times or on weekends.

Our services

We consult and train our customers online and via our training portal.

Individual consulting

We accompany your organization on the way to secure CSV implementation: apt

  • The regulated company is at the core to ensure patient safety, product quality and data integrity
  • Management will commit to the requirements of the regulated environment.
  • The employees will understand and implement the working world and the working methods of the regulated environment.
  • The service providers will see themselves as an extended workbench of the regulated company and will act accordingly.
  • The computerized systems and processes are validated exactly as it will be required based on risk and must be questioned with critical thinking.
  • The work instructions and process descriptions are formulated precisely and are aimed at the actual regulatory purpose.
  • Coordinated forms contain exactly the information required for the regulatory work environment.
  • The process interfaces to the external and internal service providers are defined precisely.
  • The scope of the documentation is managed according to the regulatory requirements.
  • The service providers are accurately selected and qualified according to the regulatory purpose.
  • The employees are appropriately prepared for the relevant audits.
  • The internal CSV team is trained according to the requirements in a targeted and appropriate manner.
  • The management receives appropriate rules for the control and traceability of the implemented measures.


In our online training portal CSVAcademy you will be trained in our modules in video lessons all about the CSV.

You can choose the place and time when and where you conduct the training. A video covers a lesson. You can decide for yourself how many lessons you want to watch in a row.

The lessons build on each other. Once you finish the current lesson, you will be unlocked for the next one. You can repeat the viewed lessons as often as you like.

After a thematic block, an appointment is made for a consulting session with one of our experienced CSV consultants. You can ask questions in this session about the current learning material or about CSV topics in your work environment.

Module 1: The world of CSV

  • Introduction to CSV
  • Regulatory requirements
  • Implementation of the regulations with the help of norms, standards, guidelines, instructions and guides
  • Part 11 & Annex 11
  • 5 chapters
  • 13 lessons
  • 3 consulting sessions

Module 2: System Development Lifecycle

  • The most extensive module for the complete guide GAMP® 5 in general
  • and the 2nd edition in particular
  • Detailed explanation of all 4 phases of the SDLC and their transitions:
  • 25 chapters
  • 147 lessons
  • 11 consulting sessions

Module 3: CSV Specialist

  • Selection process to assess the knowledge of suppliers, subcontractors and service providers
  • Establishing and maintaining relationships with suppliers, subcontractors and service providers
  • Inclusion of suppliers, suppliers and service providers in your CSV processes
  • Supplier Good Practices
  • Contracts and their attachments such as SLAs and the QAA including suitable KPIs
  • 5 chapters
  • 19 lessons
  • 3 consulting session

Module 4: CSV Auditor

  • Audit forms
  • Audits according to GAMP® 5
  • Preparation, implementation and follow-up of audits
  • Audit specifications according to norms and instructions such as the FDA
  • 8 chapters
  • 23 lessons
  • 3 consulting sessions

Individual training packages

We are able to arrange tailormade packages or solutions for you from the modules, based on your knowledge and experience.

Visit our YouTube channel @CSV-Akademie or simply contact us directly:


We conduct online internal and external audits as well as Mock audits. We prepare your employees for such audits with authorities and notified bodies under realistic conditions.

We instruct suppliers and service providers and show them which requirements they have to fulfill in a regulated industry.

We comply to GAMP® 5 - 2. Edition and the requirements of the FDA with MDSAP and QSIT considering the specific standards as well as the regulatories and directives of the EU.

We also carry out audits in accordance with ISO 27001 with regard to ISMS (Information Security Management Systems).


We consult and train our costumers online in the industries pharmacy, biotechnology, and medical technology.

Pharmaceutical Industry

We train and consult online pharmaceutical customers regarding CSV and GxP based on GAMP® 5 - 2nd Edition. We help you to validate your production and business processes as well as the related systems.

Depending on the systems we coach and consult online your employees regarding the validation of applications and the qualification of IT infrastructures. Even though you outsource your IT Infrastructures to an IT provider i.e., cloud services.

We are glad to support your QA team by reviewing documents, maintaining your document management system (DMS) and creating standard operating procedures (SOPs), forms and templates.


Not all biotechnological companies manage the transition from a GLP to a GMP company. We help you with internet coaching and internet consulting to change from a laboratory view to the mode of operation of a company with Good Manufacturing Practice (GMP).

For example to bring together a LIMS (Laboratory Information System) with a MES (Manufacturing Execution System) and an enterprise resource planning (ERP) system to create an integrated network and ensure effective production in accordance with
GMP requirements.
Medical technology

Customers in the medical technical industry most follow ISO 13485:2016 for quality management systems (QMS) and ISO 14971:2019 for risk management systems (RMS), as well as the directives and regulations of the EWG council regarding MDD (Medical Device Directive) or better yet, MDR (Medical Device Regulation) and IVD (In-vitro Diagnostics) with IVDD and IVDR.

We consult and support our customers
via internet regarding those topics and the verification of medical devices and their software. Thereby the IEC 62304 Edition 1.1 and if applicable the IEC 82304:2016 are the basis. 

Moreover, we can assist you in considering related processes and systems regarding CSV at your company and the related documention.

This is recommended in the GAMP® 5 guide document with the 2nd edition, which was also co-authored by the FDA and European regulatory authorities (EU and UK). Not only the verification of medical devices and their software, but also the validation of the business and operational process and their computerized systems for the procurement of raw materials, production and distribution of medical devices and their software are now in focus.
We also provide the EC REP within the EU and CH REP for Switzerland regarding medical devices.

About us

We are a motivated team of trained staff with many years of experience.

Thomas W. Höhle

Thomas W. Hoehle
Diploma in mechanical engineering at the Technical University of Darmstadt

Projekt manager (Fraport AG)

Principal Consultant (PriceWaterhouse Coopers Unternehmensberatung GmbH)

Founding of the engineering office® as a trainer and consultant for software testing, test management, and quality management (QM)

CSV expert und SME (Subject Matter Expert) for compliance and GxP especially for GMP and GDP

Managing partner GmbH

Service mark CSVapt®

Founding of online training portal CSVAcademy

The foundation of the engineering office CSV CSG - Computerized System Validation Consulting Services Group

Our locations

Our partners

BFMT Group

All from a single source.

"Everything from a single source" is an integral part of the corporate philosophy of the BFMT Group, they take care of you sustainably and are your partner in all corporate matters. BFMT offers you holistic services and solutions - compact and competent. The continuous further training of the experts of the BFMT Group has a high priority in the company culture. Additionally, the BFMT Group has a widespread network of experts.

The employees of the BFMT Group have extensive knowledge in the areas of auditing, tax consulting and management consulting. The experts of the BFMT Group have demonstrated this knowledge, among other things, through subject-specific personal certifications. The BFMT Group supports the engineering office® as a cooperation partner.

QUAREGIA supports manufacturers of medical devices, in-vitro diagnostics, combination products and software in the areas of

  • Quality management
  • Software life cycle processes
  • Cyber security
  • Technical documentation
  • Clinical evaluation / performance evaluation
  • CE marking
  • International product approvals
  • Regulatory Affairs

Our training partner sekulab is a provider of professional training.

  • Mass Spectrometric Non-Target Screening
  • Bioinformatics
  • Analytics: data interpretation mass spectrometry (MS)
  • Biology: Modern methods of isolation
  • GMP, quality and risk management
  • Clean room

Our ecological footprint

CSV Consulting Services Group is an Internet training and Internet consulting organization.
We are aware of our particular responsibility for a clean environment. Therefore, at the end of the business year, we donate a part of our profit to projects and organizations to support tree planting.
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