Due to the increased demand for 21 CFR-11 capabilities within the already popular validator end-of-line label and packaging inspection solutions, Acrovision has now entered the marketplace.
The Hertfordshire-based company – a leading supplier of automatic identification – has already received its first order for a Validator system with 21 CFR-11 functionalities.
The 21 CFR part 11 rule provides criteria for compliance of all regulated electronic records systems, and further provides guidelines for product safety and traceability in electronic records and control systems in pharmaceutical and other industries. The rule serves to address data security, data integrity, audit trails, and signature authority.
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 (ES):
- Individual and Multi-level Passwords for all users
- Specify Frequency of change / Alpha/Num / Case
- Based upon cryptographic methods of originator authentication
- Audit Trail
- Who logged in
- Which camera they logged into
- When they logged in
- What terminal they logged in from
- What changes they made
(All time and date stamped)
Back-up and Restore Routines:
- Disaster Recovery
- “Like for Like” Exchange
- Formally define how all elements of your system are supposed to work.
- Relevant documentation
- Code Control
Acrovision is hoping that its new offering will help them 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.
Furthermore, Acrovision 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.
For more information on Acrovision, visit: www.acrovision.co.uk