How to Effectively Meet FDA Reporting Requirements During a Recall

One of the most recognizable government agencies is the Food and Drug Administration (FDA), which is responsible for protecting public health by monitoring the production and distribution of many product categories, including various foods, drugs, vaccines, medical devices, and cosmetics. Companies who manufacture goods in these categories must adhere to strict policies enforced by the …

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, …

Can Your ERP Handle Pharmaceutical Serialization?

Pharmaceutical Serialization with Deacom

Serialization has been a hot topic in the pharmaceutical industry and will continue to pick up speed as the DSCSA deadlines continue to rollout. Next up: November 2017 when all pharmaceutical manufacturers must serialize down to the unit level. Consider this: A contract manufacturer of aspirin needs to produce one pallet of product for their …