Pharmaceutical and medical device manufacturers are very concerned about quality in the manufacturing and packaging of their products as a result of FDA regulations and guidance, in addition to internal quality and professionalism standards of cGMP. Webscan fully supports our customers in their quest for best achievable quality in manufacturing practices. The FDA has issued many documents offering guidance on computer software and hardware validation principles generally directed to medical devices. More specifically “General Principles of Software Validation; Final Guidance for Industry and FDA Staff’ was issued on January 11, 2002.
It is Webscan’s goal to be fully compliant with FDA guidance on validation principles. The Webscan validation protocol is designed to help insure the highest quality standards are being met and follows the previously mentioned guidance. 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.
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. For some verifier models, certain symbols are skipped in the protocol due to field of view of x-dimension constraints (contact Webscan for more information). A Webscan representative will normally interview a customer representative to discuss the validation protocol available for a particular model of Webscan product and to discuss the protocol coverage related to the product and its intended use and ensure that the validation protocol will meet their needs. Validation protocols require the purchase of a calibration and conformance standard test card used in the performance qualification (PQ section of the protocol).
The Webscan Validation Protocol is a copyrighted work product and is sold on the basis of validating one TruCheck system. For validation of multiple systems, volume pricing is available for multiple copies. Validation Protocols and test symbols are always provided in hard-copy format only, not electronically.
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.
Read more about quality for pharmaceutical packaging and medication anti-counterfeiting from Cognex.
Please contact verifiers@cognex.com for more information if validation applies to you.