Label Control and Printing System

FDA’s 21 CFR Part 11 Compliance

LCPS is an application that provides control and traceability of labeling processes in a regulated environment. Developed with the requirements of several pharmaceuticals, LCPS provides compliance with FDA’s 21 CFR Part 11 regulations.

LCPS supports desktop printing as well as on-line print and apply printing capability providing expandability. RFID is supported in the printer’s (embedded) encoder. Data is validated against customer’s ERP databases ensuring integrity and avoiding data import functions. LCPS can work standalone or it can be integrated to work with the most popular label designing software.

LCPS APPLICATION

LCPS is an application that allows label printing for product identification in a regulated environment providing FDA 21CFR Part II compliance.

Security, Integrity & Traceability

• Restricts access to unauthorized individuals.

• System maintains unique encrypted user and passwords of individuals providing traceability and accountability of actions.

• Date and time stamped audit trails that record operator access and entries.

• Record changes can be faced to the original values providing compliance with the CFR Part 11.

• Password will expired upon a predefined number of days.

• User Access Definition can be configured to restrict access to specific

• LCPS application functions.

• Users can be grouped as operators, verifiers and QA personnel to limit approvals.

• Generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copy.

• Each user leaves an electronic signature in all processes.