
Overview
System Requirements for Quantity One 1-D Analysis Software | ||
PC | Macintosh | |
Operating system | Windows 2000 or Windows XP | Mac OS 9.2.2 or Mac OS X 10.3 (except Gel Doc XR) |
Processor/model | Pentium ≥333 MHz | PowerPC G3 or better (except Gel Doc XR) |
RAM | ≥256 MB | ≥256 MB |
Hard diskspace | ≥3 GB | ≥3 GB |
Monitor | 17", ≥1,024 x 768 resolution (absolutely required), true color | 17", ≥1,024 x 768 resolution (absolutely required), millions of colors |
USB port | Required for the hardware security key | Required for the hardware security key |
Printer | Optional | Optional |
System Requirements for Gel Doc XR System | ||
PC | Macintosh | |
FireWire port | Free FireWire port or PCI slot required | Free FireWire port or PCI slot required |
System Requirements for ChemiDoc XRS and VersaDoc Systems | ||
PC | Macintosh | |
PCI slot | Free PCI slot required | Free PCI slot required (for compatibility with Mac G5, contact technical support) |
System Requirements for PharosFX System | ||
PC | Macintosh | |
USB-2 | USB-2 | USB-2 |
System Requirements for EXQuest Spot Cutter | ||
PC | Macintosh | |
USB | One port required | EXQuest spot cutter not supported on Macintosh |
Quantity One | Quantity One Basic | |
Acquire images | X | X |
Open TIFF images | X | X |
Export to TIFF | X | X |
Print images | X | X |
Text tool | X | X |
Line tool | X | X |
Auto-align text | X | |
Volume contour tool | X | |
Volume freehand tool | X | |
Volume rectangle tool | X | X |
Volume circle tool | X | X |
Volume array tool | X | |
Volume report | X | X |
Colors | X | X |
Plot density | X | X |
Multichannel viewer | X | |
Image stack tool | X | |
3D viewer | X | X |
Transform | X | X |
Crop | X | X |
Advanced crop | X | X |
Flip | X | X |
Rotate 90 degrees, 180 degrees | X | X |
Custom rotate | X | X |
Frame lanes | X | |
Detect bands | X | |
Compare lanes | X | |
Gaussian model bands | X | |
Contour | X | |
Assign MW standards | X | |
Match bands | X | |
Show band models | X | |
Lane report | X | |
Phylogenetic tree | X | |
Similarity matrix | X | |
Automation manager | X | |
Colony counting | X | |
Differential display | X | |
ReadyAgarose 96 Plus wizard | X | X |
Title 21 Code of Federal Regulations (CFR) Part 11 — Electronic Records; Electronic Signatures from the United States' Food and Drug Administration (FDA) provides a standard for regulated companies for data security and integrity, electronic records, and electronic signatures. The regulation is mandatory for the pharmaceutical and biotechnology industry because the regulation affects all drug and pharmaceutical products intended for the U.S. market.
The CFR compliance features are available as optional modules in Quantity One analysis software and PDQuest
2-D analysis software.
System Access
To provide the security required for compliance with the 21 CFR Part 11 regulations, the software's security model is layered on top on the Microsoft Windows operating system (2000 or XP Professional) security functions.
The operating system has to be properly configured otherwise the system will not be secure and, therefore, will not be in compliance. The access control of the application includes the following features, based on the Windows domain/workstation:
- A log-in screen before the application starts
- Global audit entry for security, failed log-in, time out, signatures
- Automatic timing out of inactive user after a certain time
- Display of logged-in user in application window title
- Allows user groups with different access levels
The access control allows different user groups and different levels of authority:
- Administrator — system administration and full application access
- User — full application access
- Technician — only image acquisition and spot cutting
- Guest — only viewer mode
Data Security
The accuracy of the electronic copy is confirmed using a secure checksum in Quantity One software. These features are provided to ensure protection of records:
- The original raw data is saved in a backup file; this backup file is read-only and cannot be modified
- The data will be saved with the user security of the signed-in user; this will prevent unauthorized users from opening, modifying, or deleting this data
- Records created on a 21 CFR 11 system cannot be opened on a non–21 CFR 11 system, and vice versa
Audit Trails
Secure time-stamped audit trails are implemented in Quantity One to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. The audit trail can be exported to file, printed, and filtered (that is, to show only signature events).

Interactive audit trail of operator with highlighted entry corresponding to image.
The audit log includes:
- Time stamp
- User name
- Action details
- User comment (optional)
- Version of software used
Electronic Signatures
Electronic signature capability allows data files to be previewed and approved prior to further processing. The name, date and time of signature, and the meaning of the signature are stored as part of each electronic record. When a signature is performed, the associated data will be automatically saved and locked. Signed files cannot be changed or overwritten.
Image acquisition and analysis from all Bio-Rad imaging systems is simple with Quantity One 1-D analysis software.
Read full description
This product contains electrical or electronic material. Learn more about Bio-Rad's EU Recycle Program
Call us at 1-800-4-BIORAD (1-800-424-6723)
I cannot find the Certificate of Analysis I am looking for. Help!
When using our online Certificate of Analysis search tool, keep the following in mind:
- Make sure you entered the correct catalog number and lot/control number in the search fields
- If you have a kit, try looking up the Certificate of Analysis using the kit information as well as the information for the individual components
- The Certificate of Analysis that you are looking for may not be available via the website. In that case, you can contact your Bio-Rad representative or use the Request Form
If you cannot find the Certificate of Analysis you are looking for, please Contact Us.
Where can I find the catalog number, SKU number, or product number?
The catalog number, SKU number, or product number is printed on your product label. See the sample label below for the location of this information.
Where can I find the lot or control number?
The lot number or control number (one or the other, not both) is printed on your product label. See the sample label below for the location of this information.

Why are Certificates of Analysis not on the Documents tab?
Certificates of Analysis are associated not only with a product, but also with a specific lot of that product. For a given product, there may be several Certificates of Analysis, especially if it is an older product line and has had several lots produced over the years. Using the Certificate of Analysis search tool, you can enter the catalog number and lot/control number for the specific product you have on hand and download the exact Certificate of Analysis you need.
I have a batch number, not a lot/control number. How do I find the Certificate of Analysis for my item?
You can use the batch number in place of the lot/control number. Use the Certificate of Analysis search tool, entering the catalog number as usual and the batch number where the lot/control number would go.
Can I get a Certificate of Analysis even if my item is expired?
Yes. While we do periodically remove Certificates of Analysis for site maintenance purposes, we typically keep them available well beyond a product's expiration date.
Why does it say "Product Name Not Found" for a Certificate of Analysis listed in the search results?
There are Certificates of Analysis that correspond to products that are either discontinued or simply not available on the website. In these situations, the Certificate of Analysis is available for download, but other product details, such as the product name, are not.
Why does it say "Not Available" for a Certificate of Analysis listed in the search results?
In this case, you have entered a valid catalog number and lot/control number and we have located the Certificate of Analysis. However, for some reason, the actual file itself is unavailable.
Please use the Request Form here or contact your local Bio-Rad Representative so that we can send you the Certificate of Analysis.
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