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For companies operating within the healthcare field and wishing to export their products to the us , adopting 21 CFR Part 11 is of fundamental importance. This standard was created by the FDA and aims to manage computerized automation systems in pharmaceutical industries.

Adapting to 21 CFR Part 11 are often interesting for several industries, since Anvisa (National Health Surveillance Agency) also has the same standard, RDC 301/2019. It is worth remembering that the standard and safety of the assembly of companies linked to the health area must be constantly ensured, thus guaranteeing the minimum risk to patients.

For such control, it’s necessary that the processes meet specific standards of control bodies throughout the assembly chain, avoiding any error or violation. Thus, the 2 fundamental points of the 21 CFR Part 11 standard ask the standards required for data storage and electronic signatures and for the whole life cycle of medicines, from development to distribution and sale.

What Is Systems Validation?

The validation of systems may be a step administered with the corporate that hires or buys a system. It are often just software, equipment, or both. And it takes place from the initial stage — prospecting for solutions — to the post-installation and complete operation stage, where everything must be recorded.

Such records are intended for a series of documents to automatically validate the system for the operation that the institution needs. For Anvisa, exclusively online processes are considered a kind of software, and for that reason, they need to be validated. This is true albeit they’re not installed on any machine.

In this way, companies within the health sector have increasingly invested within the automation of processes and within the use of electronic records to exchange paper. Such a change guarantees the integrity of the knowledge generated through automation. That is, they need to always represent reality, inviolable and stored during a safe environment, additionally to being produced automatically and free from any failures.

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