Related Products

• Detailed Required Material List
• Installation Qualification Procedure and Checklist

The Absorbance Test Plate (p/n 7260522) is required in order to run some procedures specified for absorbance and multi-mode readers, but is not included and must be ordered separately.

Please Note: BioTek's Product Qualification Packages include thorough procedures to allow a user to perform Installation Qualification, Operational Qualification and Performance Qualification. Periodic maintenance procedures are also included to assist in maintaining the instruments for optimal performance. The Product Qualification Packages contain only documentation and Procedures. Note: Many of these procedures require the use of QC Test Solutions or other accessories, but these are not included with the Product Qualification Packages.

The Gen5™  IQ package contains BioTek's recommended Installation Qualification procedure. The procedure provides instructions for confirming that the Gen5 software has been supplied as ordered and ensures that the software is installed and configured properly for your laboratory environment. The procedure includes an “IQ Checklist” for recording that the IQ tasks were performed.

The Gen5 Validation Package is designed to help you run a short validation session to ensure that the software operates properly in your IT and laboratory environment.*

The Gen5 Validation Package contains:

• Gen5 IQ (Installation Qualification) and Checklist
• Data Reduction Validation Plan and Checklist
• Gen5 protocols and data input files for use with Data Reduction validation
• Export / Report Validation Plan and Checklist
• Security Validation Plan and Checklist (for Gen5 Secure and Gen5 IVD users)

BioTek provides procedures and checklists in PDF format for easy viewing and printing.
We also provide the Microsoft Word source files for customers who wish to modify the files or extract portions of them for use in their own procedures.

* All versions of Gen5™ software are fully validated to operate per written product specifications. Validation is conducted at BioTek Instruments, Inc., utilizing hundreds of controlled test protocols which challenge the data transfer, data reduction, and instrument interface functionality. The integrity of the Microsoft® Excel spreadsheet data transfer and operation are also validated. Additionally, the Electronic Signature aspects of the software are fully validated per US FDA’s 21 CFR Part 11 software requirements.

All software validation activities are certified to meet the US FDA and ISO 9001/ISO 13485 requirements. Click here to see a copy of the most current BioTek Gen5 Validation Certificate.