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Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by Henry Macartney

As all medical device manufacturers know, life sciences firms are bound by GxP. [...] Read More

Posted in Supply Chain Management

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by Zuhdi Hussein

When GxP firms take actions to maintain compliance with recommendations from. [...] Read More

Posted in Quality Systems Regulation

Do You Know Enough About EU Annex 11 For Computer Systems Validation?

April 22nd, 2014 by Zuhdi Hussein

Computerized systems play critical roles in helping GxP firms improve their. [...] Read More

Posted in Medical Device Consultants

Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by Zuhdi Hussein

Companies which must work in a GxP environment rely on a range of different. [...] Read More

Posted in IT Systems Software Validation

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by Zuhdi Hussein

In order to go public in the USA with a medical device, developers must pass. [...] Read More

Posted in mock audits

Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by Zuhdi Hussein

Although currently seldom used, cloud services are increasingly popular for. [...] Read More

Posted in Information Security Architecture Design

Life After An FDA Form 483

April 7th, 2014 by Zuhdi Hussein

FDA inspections don't always end smoothly. Field agents may decide that the. [...] Read More

Posted in Notice of Inspectional Observations

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