Entries with Keyword whitepaper
The 5 Essential Elements of a CAPA System
Using a compliant quality management system (QMS) with a CAPA subsystem, your company will be ahead of the 465 companies with CAPA-related FDA 483s.
5 Tips to Pass Your FDA or ISO Audit with Con ...
An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device manufacturers the first audit of your processes can be as nerve-racking as the first time you defended your business plan before venture capitalists, submitted your first 510(k) application, or delivered your product to market.
What Are the Key Elements of a Quality Manage ...
Having an effective quality management system (QMS) in place for life sciences companies is critical to help organizations reach their product development milestones and achieve commercialization success.
Part numbering system: How to get started
This article describes factors to consider when selecting a part number system and how to manage part numbers effectively.
What is the Right Part Numbering Scheme for y ...
We explain the pros and cons of non-intelligent part numbering versus intelligent part numbering and offer best practice insights.
Managing Your BOM: Spreadsheets vs. Product L ...
Manufacturers rely on the item, assembly, documents, and related product record information that is included in a bill of materials (BOM)
Is Product-Centric QMS Right for Your Company ...
Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture
Managing Your New Product Development (NPD) P ...
Product development involves multiple teams, locations, and partners. These dispersed teams must be synchronized to speed NPD.