Intelligent Quantifier-11

Intelligent Quantifier-11

Software Overview

Intelligent Quantifier-11 (IQ-11) for Windows 10 and Windows 7, a software system for analyzing scanned images of 1-D electrophoresis separations, is fully compliant with 21CFR Part 11. The 21CFR Part 11 features are not an add-on; they are an integral part of the program. Analysis methods, standards, and report templates are developed at the Administrator access level. (Details further below)

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Options: IQ/OQ, Installation and Training, Complete Systems

Printable version of product features. (PDF)

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Fully 21 CFR Part 11 Compliant

• Not merely Windows login and password, but fully integrated logins, passwords, and record signings
• Signing to acquire, save changes, and report
• Optional comments for every signing
• User name and title on all data reports
• Analyst, supervisor, and administrator access levels
• Audit trail of all operations
• System audit trail

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Excel is not GMP Compliant. IQ-11 Is!

• Do you need proprietary calculations or reports in a fully GMP-compliant environment? Excel is not the solution!
• Have you received an FDA 483 observation about your lab image analysis system? Excel is not the solution!

We can help you. With Bio Image Systems, we write software and own all rights to IQ-11. We can integrate your calculations and reports into IQ-11. Bio Image is the solution!

• All calculations done inside IQ-11
• Full Data Integrity – audit trails, two-factor signings, data versioning, and much, much more
• No transposition errors
• No linking off to potentially non-compliant applications

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Powerful Reporting Capabilities

• Electronic signatures AND electronic review
• Administrator created report templates specify report header and footer, lane header and footer, and band data
• Choose from dozens of data and meta-data items
• Specify every lane on a new page, or auto-fit multiple lanes per page
• Every report must have a signature, date and time, and page N of M.

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Complete 1-D Analysis Package

• Automatically detects lanes, finds bands, including irregularly shaped bands, i.e., biphasic bands, "smiling bands," or saturated bands that are substantially wider than the rest of the lane
• Automatically quantifies bands by defining actual band boundaries based on inflection point analysis
• Edit all lanes, bands, and standards
• Mw / IEF standards
• Dilution series (concentration standards)
• Image prints with annotation
• And we have a blot analysis package too

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How To Buy Our Software?
Send an email for a quote.
info@bioimage.net