Looking for a company providing software validation services 21 CFR part 11 compliant

[JulienV]

Hello everybody,

I've developed an application in .NET C# 2.0 for pharmaceutical industry, and I'm looking for a company specialized in software validation (21 CFR PART 11 compliant), preferably in France or Belgium, to complete the validation of the software.

Have you had good or bad experiences with this kind of companies in Europe?

Thank you,

Julien V.

[Ofni]

Greetings JulienV:

Ofni Systems is your source for validation services and solution tools to meet
FDA compliance on 21 CFR Part 11. Ofni Systems also has experience with ANNEX11 validation compliance aspects.

We are located in North Carolina, USA and are able to provide services and tools via WebEx to anywhere in the world.

We invite you to take a look at our website for more information about the various Validation services, solutions and more that Ofni Systems can provide by going to this url:
http://www.ofnisystems.com/Validatio...Validation.htm

We welcome talking with you at any time to answer any questions.
Best regards,
Ofni Systems, Inc.
www.OfniSystems.com

[JulienV]

Dear,
Thanks for your message, that's exactly what I'm looking for. I'll send you a message today throught the "Request a quote" link of your website.
Best Regards,
Julien V.

[dnettleton]

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects.

David Nettleton
FDA Compliance Specialist
Computer System Validation
916-773-1470 phone
dnettleton@computersystemvalidation.com
www.computersystemvalidation.com

[soluoma]

Originally Posted by JulienV

Hello everybody,

I've developed an application in .NET C# 2.0 for pharmaceutical industry, and I'm looking for a company specialized in software validation (21 CFR PART 11 compliant), preferably in France or Belgium, to complete the validation of the software.

Have you had good or bad experiences with this kind of companies in Europe?

Thank you,

Julien V.

Hello Julien,

CTG Regulatory Compliance Service is your solution partner to deliver validation & QA services to meet regulatory requirements (21 CFR Part 11, EU GMP Annex 11, EU GMP Annex 15). CTG has more than 40 years experience in IT and has qualified and experienced pool of consultants.

CTG has offices in Belgium, Luxembourg, UK, and USA.

More information available on http://www.ctg.com/lifesciences/compliance.htm

Kind regards,
Stanley Oluoma
Regulatory Compliance Manager
CTG Belgium N.V./S.A.
Mobile : +32 (0)496 598 586
E-mail: stanley.oluoma@ctg.com