Wednesday, May 14, 2008
FDA COMPLIANCE SOLUTIONS NEWS AND VIEWS
FDA Compliance Solutions, Inc. is pleased to periodically offer regulatory updates, news and views.
PART 11
Still ticking. Look for Part 11 to be part of the normal inspection process. Distinctions of open and closed systems won’t mean as much, but Part 11 will remain an important regulation.
BAR CODING
Remember, all systems producing bar codes, as part of pharmaceutical product labels must be validated. This might offer unique compliance opportunities for hospitals and pharmaceutical companies.
RISK ASSESSMENT
FDA is expecting that organizations it regulates use Risk/Hazard Assessment for planning and management. Risk Assessment can help define when you are done a validation project and “what is enough”.
ISO 14971 is a recommend approach along with Fault Tree Analysis, FEMA and HACCP.
Risk/Hazard Assessment can really help you plan more efficient use of your resources and time. The USFDA and FDA Compliance Solutions Inc., is confident that these tools will help you manage much more effectively and more efficiently.
SOFTWARE VALIDATION FOR MEDICAL DEVICES
On May 11, 2005, The FDA announced a new Guidance for The Content of PreMarket Submissions for Software Contained in Medical Devices. FDA Compliance solutions is preparing a review and checklist for this new guidance. Contact us at 856-216-1516 or at PhilSax@FDAComplianceSolutions.Com. for information.