Blog

News

Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by

Compliance ConsultingAs all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms [...] Read More

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with [...] Read More

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

April 22nd, 2014 by

Computer Systems Validation[...] Read More

Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by

IT Software ValidationCompanies which must work in a GxP environment rely on a range of different technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also [...] Read More

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by

CAPA Inspection[...] Read More

Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by

Cloud Services ValidationAlthough currently [...] Read More

Life After An FDA Form 483

April 7th, 2014 by

FDA Form 483 Warning LetterFDA [...] Read More