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How CSV, GxP, and QS nowadays are provided by internet coached and internet consulted,

the transfer of know-how will be enforced, whereas costs will be minimized and it will be explicitly more time for coaching and consulting ...
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. 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.
  • Individual costumized strategy: We commit ourselft to the custumer and realize together with the costumer the agreed strategy .
  • 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.

Auf Bewerbungen wird in der Regel innerhalb von 1-2 Werktagen geantwortet.
Our costumers
We consult and coach our costumers online in the industries pharmacy, biotechnology, and medical technology.
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pharmacy
Source: Steve Buissinne

Pharmaceutical industry


We coach and consult online pharmaceutical customers regarding CSV and GxP based on GAMP5. 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.
biotechnology
Source: Ann San
medical technology
Source: Thomas G.

Medical technology


Customers in the medical technical industry most follow ISO 13485:2016 for quality management systems (QMS) and ISO/IEC 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).

We consult and support our customers
via internet regarding those topics and the validation of computer software (VoCS), which supports a medical technical product.

Moreover, we support you if you consider related processes and systems regarding CSV at your company and the related documention.

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 also instruct suppliers and service providers and show them which requirements they have to fulfill in a regulated industry. We comply i.e., to GAMP5 and the requirements of the FDA with MDSAP and QSIT.

audits and inspections

Source: Gerd Altmann

sustainability by tree planting

Source: Umut AVCI

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
Foto of 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.

I am coaching and consulting freelancers, entrepreneurs and desider of small and mid-sized companies on the areas software testing, test management, QA and CSV as well as audits according to GAMP5, ISO 13485 and ISO 14971.

I consult and coach companies long-ranging and lasting. This shows my consulting periods of one to seven years so far.
How does the application process look like?

1. You make an application to the first interview at no charge.
Within a consulting interview of about 45 minutes we identify which services you, your company and your employees need and which way we shall take and which strategy we shall follow to transfer the know-how to you, to your company and to your employees. 
2. A team member will call you and make a short interview.
We offer our cooperation if we are absolutely sure that we can help you.
The internet coaching and internet consulting is suitable for every company but it could be that it does not fit to your current situation. But we will tell you as well when this service will be appropiate to you.
3. We will coordinate an appointd time together.
We are looking for a date for the first interview at no charge. The date shall be prompt so that the information you provide and the problems you name are up-to-date and can be approached as fast as possible.
Our location

You find us at the industrial park Hechtsheim via the junction of Autobahn A60 Mainz-Hechtsheim-West.

Cathedral of Mainz Germany
Make an application for a first interview at no charge now!
Please note: straight physically it is not possible for us unfortunantely to take care of a handful costumers and to deliver at once strong results.
Our services are asked strongly. To work with us together an application is necessary. During the first interview at no charge we find out together which strategies for our company and your employees are suitable best.
Click the button below to be directed to the application: