Manufacturers may find themselves without the resources and processes needed to effectively and efficiently...
Audits
Non-Conforming Material Reports
A Non-Conforming Material Report or NCMR is the standard way to report a material that does not meet the...
Proctor & Gamble Cosmetic Recall
On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo and...
FDA Establishment Types
When registering a medical device with the FDA the type of product influences the method of pre-market application...
Statistical Techniques for Medical Devices
One of the more ambiguous parts of the Quality System Regulations, 21 CFR 820, is making judgments based on...
510K Submission Tips
Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow for...
Making a Change to a QMS
A Quality Management System (QMS) is often designed well before a company starts the development of its...
What to Do with a Bad QMS
For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) is...
5 Reasons Why Internal Auditing is Important
An internal audit program is vital for proper monitoring and assurance of products. It is also essential to...
Audit Readiness
Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur getting...
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