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Get Certificate Of Analysis - Kem-en-tec Diagnostics
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How to fill out the Certificate Of Analysis - Kem-En-Tec Diagnostics online
The Certificate Of Analysis - Kem-En-Tec Diagnostics is an essential document that verifies the quality and specifications of your diagnostic product. This guide provides clear and step-by-step instructions on how to fill out the form online, ensuring accuracy and compliance.
Follow the steps to complete your online form.
- Click ‘Get Form’ button to obtain the form and open it in the editor.
- Locate the section for 'Lot no.' and enter the unique lot number of your product.
- In the 'Date of manufacture' field, input the date when the product was manufactured.
- Fill in the 'Exp. Date' with the expiration date of the product, noting that it should be stored at 2-8°C in an unopened bottle.
- In the 'Analysis' section, record details regarding dilution and analysis results. Include information about the dilution of Rabbit anti-human IgG-AP and activity testing.
- Complete the specifications section by confirming that the average non-specific binding (NSB) signal is less than 0.200 abs, the color is a clear solution with no distinct color, and that the pH is between 6.60 and 7.00.
- Document the results in the given fields, including 'Activity', 'NSB', 'pH', and 'Color'.
- For the 'Storage' section, describe the short-term and long-term storage conditions for the product.
- Indicate the person who performed the analysis by filling in their name and the date. Include the signature if required.
- Provide approval details by entering the approver's name, date, and signature in the designated fields.
- Finally, after completing all fields, save changes, download, print, or share the form as needed.
Complete your Certificate Of Analysis online to ensure compliance and accuracy in your documentation.
A CoA is usually required whenever a customer needs to report to a regulatory agency or a government body. These typically include the Food and Drug Administration (FDA), the International Organization for Standardization (ISO) or The Occupational Safety and Health Administration (OSHA).
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