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Testing in Regulated Industries

​​​​​​​​At NNIT we know about regulated industries and GxP

For companies working with clinical drug development, pharmaceutical production, medical devices, or in the healthcare business, it is of the utmost importance to adhere to regulatory requirements.
 
Your IT systems must be in a validated state at all times, and you have to be able to proof how you have planned, tested, qualified, operated, and maintained your IT systems. Everything has to be done with focus on patient safety, product quality, and data integrity. This enables you to pass periodic audits made by the authorities, and hence ensuring your business.
In order to live up to these strict requirements you need deep knowledge and experience in translating current legislation and standards, so you can fulfill the requirements in standardized processes and best practice methods.
 
At NNIT we have test managers and testers with many years’ experience with IT system development, test, and validation in regulated industries from participation on GxP projects delivering testing services based on the principles set forth by for instance GAMP5 and ICH Q10.​
NNIT was born from the pharmaceutical industry and we have more than 20 years’ experience working with Life Sciences and GxP.​

We can

  • Deliver testing to regulated industries covering the full product life cycle (Advise-Build-Test-Operate and Decommissioning).
  • Provide you with test managers and
  • testers with extensive experience in test management, preparation, execution, and reporting on large and complex GxP projects with the level of involvement you choose.
  • Provide industry leading best practice processes and methods that focus on patient safety, product quality, and data integrity.
  • Manage, plan, and integrate all test and qualification activities across the product life cycle with the level of involvement you choose.
  • Undertake your test management and tester responsibilities, enabling you to focus on your own business processes in close cooperation with you.
  • Provide compliance, test, and validation advisory to meet and fulfill requirements from regulatory bodies worldwide (for instance FDA, EMA, cFDA).
  • Deliver testing by integrated near-shore, and/or off-shore teams at competitive and attractive rates.
At the NNIT Test Excellence Center we are dedicated and have a passion for adding business value by working in line with current regulatory requirements. We take pride in meeting our customers’ expectations every time.

 

 


 

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NNIT here+45 7024 ​4242nnitcontact@nnit.com ​​​​​​​​​​​​https://dk.linkedin.com/company/nnitNNIT here

 

 

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