A Race for CAR-T Cell Manufacturing

The process of developing novel cancer therapies is complex. As a result, the industry is seeing a growth in in-house manufacturing for companies with a focus on cancer treatments. Companies need to move fast and efficiently, as they are facing fierce competition....

The FDA’s New Draft Guidance

More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide...

Departmental Roles of Data Integrity

Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand...

What Is Data Integrity?

Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of...