Validation Center™

The CDRH branch of the US FDA issued this draft guidance document for comment on October 21, 2009.  This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data.

The CDRH branch of the US FDA issued this draft guidance document for comment on October 21, 2009. 

This draft guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data.

In May 2009, the FDA published this draft guidance document for public review and comment. 

This 2009 Pharmaceutical Inspection Convention provides guidance to GMP inspectors of active pharmaceutical ingredient (API) operations. 

This inspector's guide indicates the following areas of focus for applications:  control room system validation & back-ups, material status control system validation & security,

This 2009 Pharmaceutical Inspection Convention provides guidance to GMP inspectors of packaging operations. 

This inspector's guide indicates the following areas of focus for applications:  electronic devices to establish identity, electronic batch records (especially security and electronic signatures)

In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities.  The annexes provide additional information that is generally applicable for both finished medicinal products and actives substances. 

See section 11 for specifics on computerized systems.

In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities.  Part II explains the principles and expectations for the manufacture of active substances used as starting materials in human and veterinary medicinal products. 

See section 5.4 for recommendations regarding computerized systems.  Refer to section 6.1 for references to electronic documents.  Read section 12 for validation expectations and section 13 for change control.

In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities.  Part 1 explains the principles and expectations for the manufacture of medicinal products.  See section 4.9 for recommendations regarding electronic records.  Refer to sections 4.26 and 5.21-5.24 for validation expectations.

In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities.  This introductory document explains the organization of Parts I-II and the Annexes, the history of PIC/S, and the documents’ revision history.