Validation Protocol-Dome Std TC-863

Validation Protocol for Webscan FlexHite Dome model. (DMV-TC863-FD-01)

The Webscan validation protocol exercises virtually all of the functions of the Webscan barcode verifier and its settings and options. Hundreds of test barcodes, each designed to test specific operational characteristics of the verifier are included with the protocol.

The Webscan validation protocol was designed for pharmaceutical and medical device manufacturers with FDA regulations and guidance to help ensure the highest quality standards are being met. This validation protocol is expected to be used in combination with the customer's own quality systems to assure themselves and FDA inspectors that their manufacturing practices meet quality and health standards.

Because this validation protocol is directed to FDA regulated pharmaceutical and medical device manufacturers, this validation protocol does not validate UID (MIL STD 130) application standard.

The protocol is a copyrighted work product and is sold on the basis of validating one TruCheck system. Validation Protocols and test symbols are always provided in hard-copy format only, not electronically, or “soft-copy” format (such as PDF or DOC, etc.).

Protocols contain photographically produced test pages, which are similar to Calibrated Conformance Test Cards and they have an expiration date of 2 years. Therefore, the validation protocol should not be ordered very far in advance of its planned use.

NOTE: There is much concern over 21 CFR Part 11 Electronic Records; Electronic Signatures Validation. Although the TruCheck system is capable of storing records electronically, this capability is not relied upon in the validation and the validation should not be considered a validation of 21 CFR Part 11 compliance. All records related to the protocol are maintained by printing on paper.