From: Control Engineering
A recently published white paper describes some of the most effective industrial security tools pharmaceutical companies have at their disposal in the era of Industry 4.0. Control Engineering Europe reports.
Protection through compliance
Operating in one of the world’s most heavily regulated industries, pharmaceutical companies need to abide by a variety of complex laws, regulations and guidelines. Sometimes, these can become the basis for an effective industrial security strategy.
The Food and Drug Administration (FDA) 21 CFR Part 11 is one of the most established regulations within the industry. It requires organisations to implement controls, electronic audit trails and systems validations and establishes standard expectations for industrial security through the use of reliable electronic documentation of the pharmaceutical manufacturing process.