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, …
Continue reading “What You Need to Know About FDA 21 CFR Part 11 Validation”
November 2017 marks an important deadline for pharma manufacturers who need to begin serialization all the way down to the item level. Yes, it may seem like a daunting task but delaying the inevitable can result in poor business decisions come crunch time. Don’t let the pressure get to you.  Start to evaluate your options …
Continue reading “How to Tell If Your ERP Can Handle Pharma Serialization”
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 …
Continue reading “Can Your ERP Handle Pharmaceutical Serialization?”
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 …
Continue reading “How Ready is Your ERP Software for the Drug Supply Chain Security Act?”
Food and pharmaceutical industries are experiencing an increase in developing regulatory requirements which can impact the finishing process of production. Most manufacturers have to manually move goods through the catch weight and serialization processes risking human error and slowed speeds. Identifying a need to automate this phase of production, Deacom is excited to deliver a …
Continue reading “Serialized and Catch Weight Goods Finished in Under One Second”