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 that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining [...] Read More

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it’s critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could [...] Read More

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

April 22nd, 2014 by

Computer Systems ValidationComputerized systems play critical roles in helping GxP firms improve their operating standards and production capabilities. In order to maintain compliance and product marketability within [...] 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 use software designed to implement and maintain valid quality controls.

Naturally, such software must [...] Read More

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by

CAPA InspectionIn order to go public in the USA with a medical device, developers must pass FDA medical device compliance audits / inspections. Equipment falls into one of three categories based upon the [...] Read More

Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by

Cloud Services ValidationAlthough currently seldom used, cloud services are increasingly popular for life sciences firms that want to keep up with their competition. These firms use distributed computing architectures to [...] Read More

Life After An FDA Form 483

April 7th, 2014 by

FDA Form 483 Warning LetterFDA inspections don’t always end smoothly. Field agents may decide that the deficiencies they observed were significant enough to issue letters detailing outstanding issues. For firms [...] Read More