How to choose the right suppliers, service providers and sub-tier suppliers, and how to monitor them to ensure FDA compliance.
Managing your Medical Device suppliers – Tips for ensuring they are truly FDA compliant
Read this article and find out more on how a Document Control System may help companies to ensure regulatory compliance.
Why my electronic “Document Control System” may only be a “Document Management System”
Learn how the SoftExpert Excellence Suite can help health industry organizations to overcome the challenges of quality and efficiency.
Streamlining Healthcare Organizations with SE Suite
How technology can contribute by supporting and automating the main steps of a food safety management system.
Leveraging Food and Beverage Organizations with SoftExpert Excellence Suite
This White paper, PECB will discuss the main points of the ISO 22000, essential regulation to adequately control the entire chain of production.
ISO 22000 – Food Safety Management System
The several factors that must be considered when determining the appropriate sample size for process validation.
Process Validation: How many sample sizes do I need?
The importance of the "risk based approach" for the correct performance and adequate safety of medical devices.
How will ISO 13485:2016 impact your relationship with suppliers?
The key clauses of ISO 13485 and the business benefits of quality management in the medical devices industry.
ISO 13485 – Medical devices quality management systems
A clear definition and measure of engagement relevant to healthcare.