Validation Services

Security and control, which is essential to part 11. A documented user account policies is a big part of that. Minimum password requirements, password expirations, automated log-outs, discreet application authorization - all of those things that are known as good practice. Best practices today will help you pass the validation, for security and control.

Organizations need to have proper controls in place. In our industry-specific ERP delivered by Navigator, you'll have a workflow that requires approvals to properly control access to information, approval of any documents which are going to be processed through the system transactions that are going to be processed through the system up to and including, having PINs, electronic PINs, to reinforce electronic signature. 

Vendors or suppliers can be approved and added to a vendor/supplier list, that may require an electronic signature in the form of a PIN, or electronic signatures in general.

As people are logging onto the system and as you have proper access control through your password, user authorization, each of each document, each piece of master data needs to be user, date and timestamp. So as, as we're taking a look at this particular screen,

Whether bill of material or a purchase order, you'll have these types of controls in quality data that can be validated with proper electronic signatures. 

Good Manufacturing Practices. A system for ensuring that products are consistently produced and controlled according to quality standards. Designed to minimize the risk, risk mitigation is involved in any production that cannot be eliminated through the testing of the final product.

So what does that mean? It means that you have a good manufacturing process in place.

You have good workflow requiring proper approvals with a trail of e-signature and a trail of traceability throughout that enforces good manufacturing practices and mitigates any risk associated with the production of that product.

Device History Records help ensure that everything that you define in that quality system is being done in this case, in the form of good engineering and change control management to support good manufacturing processes (gmp).

We've all heard of track and trace. This is the ability to be able to know what went into a product, where that product has been delivered, where it sits in the warehouse, what transaction has been performed on it, who did it, what date, and what time.

Track and trace software should allow this data to be readily available. Having a system in place that supports that is key and essential to meeting the validation challenges.

Once taking the sales orders and manufacturing the product using GMP, you'd have kept track of where they've gone using track and trace, you'll have that ability to have CAPA cases and recall products by researching and identifying, and quarantining the product.

This is all key and essential to an overall system solution that's going to support your process validation with the FDA.