What You Need to Know About FDA 21 CFR Part 11 Validation

FDA 21 CFR Part 11 Validation Process

Validating an ERP system helps a company ensure that their processes are consistent and operate in accordance with industry standards. The 21 CFR Part 11 validation process establishes documented evidence that, throughout its lifecycle, the ERP system will consistently function in accordance with its pre-determined specifications and quality attributes. For pharmaceutical and medical device companies, …

3rd Shift Harry and The Hardened Path of Destruction

3rd Shift Harry and the Hardened Path of Destruction

In this first installment of our series of 3rd Shift Harry stories, we see the catastrophic consequences of what can happen when the wrong materials are issued to a production batch. Paint and coatings manufacturers work with a number of different chemicals and materials to create their products. Paints are typically formulated according to their …

How Ready is Your ERP Software for the Drug Supply Chain Security Act?

Pharmaceutical manufacturing serialization requirements of the Drug Supply Chain Security Act

In complying with the U.S. Drug Supply Chain Security Act regulations, pharmaceutical manufacturers must ensure their ERP systems are up for the task. In late 2013 the Drug Supply Chain Security Act (DSCSA) was introduced and signed into law as a means to govern the management of pharmaceutical drugs manufactured and sold in the United …