Every company knows the importance of maintaining accurate and complete data of a high quality over periods of time and across all different formats. Having a good data integrity plan is essential and can save an organization time, effort, and money all while providing the security that the organization is not operating and making decisions with incorrect or incomplete data.
Key Performance Indicators Unlock Potential
There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference requires some book-learning, but mostly the wisdom of broad and deep experience.
The Digitalization of Quality Management Systems
One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.
HIPAA and GDPR’s impact on Medical Devices
The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.
Decorative Contact Lenses
Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact lenses. Decorative lenses are also known as
Water for Pharmaceutical Use
When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.
Investigational Device Exemption
An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Principles of Data Integrity
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...
Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of...
The Role of CMO’s in Life Sciences Manufacturing
Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing...
For a long time, healthcare was in the hands of doctors. People listened only to their doctor’s advice on how...
Importance of Document Control on a Quality Management System
In highly regulated industries, document control is among the most necessary means for compliance. A document...