Validator CFR21 – End of Line Label Inspection with 21 CFR-11 Compliance

Imagine being able to reduce the cost of managing and documenting your entire labelling lifecycle? No more paper-based systems, no more risks and only an increase in productivity, efficiency, and compliance.

Acrovision has tackled all these requirements by introducing the Validator CFR21 which will eliminate most of these common stresses found in the pharmaceutical industry and will allow for companies to meet requirements in an all-in-one system, without the expense. Furthermore, the FDA is continuously expanding the compliance to new areas of new automation systems or drug discovery, and by having this Validator in place, this will ensure constant compliance.

In addition to the standard Validator specification being able to check for correct and legible barcodes; correct and legible text such as sell by / use by date codes; correct and positioned promotion labels; and packaging quality, such as fill-level, missing cap detection, the Validator now provides the following 21 CFR-11 compliancy:

  • Electronic signatures
    • Individual and Multi-level Passwords for all users
    • Specify Frequency of change / Alpha/Num / Case
    • Based upon cryptographic methods of originator authentication
  • Electronic records
    • Audit trails
  • Back-up and Restore Routines
    • Disaster Recovery
    • “Like for Like” Exchange
  • Validation
    • Formally define how all elements of your system are supposed to work.
    • Relevant documentation
    • Code Control

This new offering allows Acrovision to provide a more complete solution to the biotechnology, drug, and medical equipment manufacturing industries, who are always looking to improve their quality and profitability, at an affordable cost.

What makes our Validator CFR21 stand out, is the fact that it is custom tailored to each customer’s needs at unbeatable pricing!

We can partner with label applicator / original equipment manufacturers (OEMs) of packaging machinery to provide a complete 21 CFR-11 compliant solution to the end-user.

Validator FDA CFR21 11

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