Computerized System Validation

for your company

adapted - precise - tailormade

provided by internet coaching and internet consulting

Transfer of know-how into your company will be enforced, whereas costs for you will be minimized and it will be explicitly more time for coaching and consulting for your employees.
Thomas W. Hoehle

Dipl.-Ing. Thomas W. Höhle

The engineering company IT-Testing.de® consults since 2004 on the areas of software testing, test management and quality assurance, and coaches on the area  of comuterized system validation and the verification of medical devices. For more audit-secureness!
And all if that digitilized.
Here are 3 additional things our costumers compliment us:
  • Maximum service: We identify with the company we are coaching and consultung. Ensuring compliance!
  • Individual costumized strategy with integrating techniques (IT): We commit ourselft to the custumer and realize together with the costumer the agreed strategy. Just with help of our service product CSVapt®!
  • Go the extra mile: We are reachable for our custumers at any time and if tasks like software tests can be performed out of odinary business times or on weekends only.

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

Pharmaceutical industry


We coach and consult online pharmaceutical customers regarding CSV and GxP based on GAMP® 5 - 2. 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.

Biotechnology


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 effective production completely according to 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 the directives and regulations of the EWG council regarding MDD (Medical Device Directive) or better 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 support you if you consider related processes and systems regarding CSV at your company and the related documention.

Our Services

We consult and consult our clients online and with our training portal.

Individual consulting

Our experienced consultants and coaches support you individual according to your needs as:

  • GxP Specialist
  • CSVapt® Consultant
  • Projekt manager
  • Team lead
  • Team member
  • Interim director

Audits

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.

CSV Academy

With our training portal you will be trained on CSV generally and CSVapt® in particular.

Basic knowledge CSV
With this Basic Module you will receive the entry to the world of CSV, GxP and compliance as well of CSVapt®.

GAMP® 5 SDLC
With the GAMP® 5* Module System Development Lifecycle (the basic module included) you will receive the advanced insights to CSV, GxP und Compliance sowie CSVapt®.
We train the 2. Edition of GAMP® 5.

CSV Specialist
With this Specialist Module (the basic and GAMP®* module are included) you receive the overall view and learn how to embed external service provider as extended workbench.

CSV Auditor
With the Audit Module you learn how you behave at at an audit, how to prepare, conduct and complete it professionally.

*: GAMP® is trademark by the international Society for Pharmaceutical Engineering ISPE®.

Our ecological footprint

 IT-Testing.de® is an internet coaching and internet consulting engineering company. 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.
About Thomas W. Hoehle
Thomas W. Hoehle
I am consultant since 2000 and established 2004 the engineering company IT-Testing.de®. There I worked as coach and consultant for software testing, test management, and quality assurance (QA).

Additionally I am specialized as expert for computerized system validation (CSV) since 2011.

Since 2021 I am CEO of IT-Testing.ch GmbH.

I am coaching and consulting freelancers, entrepreneurs and desider of companies on the areas CSV, GxP, Compliance, QA, software testing, test management and verification of medical devices as well as audits according to GAMP® 5 - 2. Edition, ISO 13485 and ISO 14971.

I consult and coach companies long-ranging and long-lasting. I set value on customer satisfaction and customer loyalty.
About Holger Greis
I am managing dirctor for marketing at IT-Testing.ch GmbH.

After some managing positions in industries like aviation and media, I assume this managing position to provide services of IT-Testing.ch GmbH to our swiss costumers.

Relevant at all my occupation was and is the analysis of and the communication with my customers. There are many ways but it is important to attain the goal.
Our locations

Cathedral of Mainz Germany

computerized system validation apt adapted precise trailormade qualification QA quality assurance good practices guidelines medical device invitro diagnostics directive test management system development life cycle software testing MOCK audit inspection regulated regulatory authorized notified bodies IT infrastructure application supplier service provider sustainability ecological footprint