Changes to the Certificates of Analysis to be in effect October/2018
Question:
What are the changes to the Certificates of Analysis?
Answer:
There are two categories of changes; one for Chromatography resins and one for Ceramic Apatite resins.
- Chromatography resins
- The current wet signature is to be replaced with an electronic signature by Quality Assurance as well as date/time stamp in compliance with 21 CFR Part 11.
- We will no longer provide a printed copy of CofA with shipments.
- Customers will be able to download an electronic copy of the CofA at www.bio-rad.com by providing the product catalog and control numbers.
- Ceramic Apatite resins
- The FTIR spectrum and protein separation chromatogram will be removed from the CofA. Customers will be able to obtain copies of the data per request by contacting your local Bio-Rad support team. The following statement will be added to the CofA: “The FTIR spectrum and Protein Separation chromatogram are available upon request by contacting your local Bio-Rad support team”.
- The current wet signature is to be replaced with an electronic signature by Quality Assurance as well as date/time stamp in compliance with 21 CFR Part 11.
- We will no longer provide a printed copy of the CofA with shipments.
- Customers will be able to download an electronic copy of the CofA at www.bio-rad.com by providing the product catalog and control numbers.
Why are these changes being made?
These format modifications are intended to standardize the formats of our Certificates of Analysis across our portfolios and to improve our Customers’ experience.
When will these changes become effective?
These changes plan to go into effect no sooner than October 10th, 2018.
Will these changes affect the product name or item number?
No, product name and item number will not be affected.
A PDF document describing these Changes to Bio-Rad’s Certificates of Analysis that includes samples of the new formats is available.
Call us at 00 800 00 BIORAD (00 800 00 24 67 23) or +351 21 47 27 717
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.
Product Guarantee
All Bio-Rad products are guaranteed to meet the specifications listed in our catalogue. Should a Bio-Rad branded product fail to meet specifications during its warranty period, it shall be repaired or replaced at Bio-Rad's discretion.
Warranty
Warranty periods are listed on quotations for specific products; however, instruments generally receive 1 year of warranty coverage from the date of shipment or installation. Instrument warranties do not include consumable parts, such as lamps, lasers, and platinum wire. Repairs have different warranty periods. Chemicals and other consumables are warranted through their expiration date or for 1 year from shipment if no expiration date is indicated. Non–Bio-Rad branded products, such as computers and computer peripherals, are covered by the original equipment manufacturer's warranty. Warranties are not transferable from the original purchaser. Warranty coverage may be void if the product is moved outside of the country where the product was originally purchased. For more information, contact your local Bio-Rad office.
Technical Support: 00 800 00 BIORAD (00 800 00 24 67 23) or +351 21 47 27 717
Download Bio-Rad's ISO Certificates:
Please reenter your email address in the correct format.
Please enter your email address.
Your subscription information already exists, we will send you an email with specific instructions to manage your existing subscription profile.
To receive the latest news, promotions, and more, sign up for Bio-Rad updates by entering your email address below. You can elect to receive only the types of Bio-Rad communications that are of interest to you..
Our Products
Home |
Trademarks |
Site Terms |
Terms & Conditions |
Imprint |
EU Recycle Program |
Privacy
|
Change Cookie Setting
© 2019 Bio-Rad Laboratories, Inc.