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Laboratory Data Errors and Corrections |
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| Date: 2003-08-09 00:00:00.0 |
| Contact: admin@globalregulatory.com |
| If your lab, or your customers' samples, are regulated by the Food and Drug Administration (FDA), do not obscure or erase original laboratory data entries when making corrections. Instead, place one single line through the incorrect information, write the new information, date the correction, and initial or sign your name by the correction. You must also provide an explanation for why the correction was necessary. The explanation will make it easier for you to remember and describe the actual situation to an auditor during an inspection that is months or years away from the time that the correction was made. This is also very helpful when an employee that is no longer with the company made a correction that needs to be explained by someone else. Never use 'white-out' or other mistake-correctors on your laboratory data or other documentation. This may indicate to a regulatory inspector that there is data that you want to 'hide'. If there is white-out in your facility, throw it away immediately! This way noone will even have the chance to use it. Never use pencil to record laboratory data, as it could be erased by someone else and changed to reflect information that you did not originally record. If you are expecting an inspection and would like to have an audit performed on your laboratory data please contact us at admin@ContractLaboratory.com. Laboratory audit services and On-Line consulting are available to help you keep your lab in compliance. Preventive Action internal laboratory audits are also very important for contract laboratories and labs in contract manufacturing facilities. This type of preventive audit will keep your data in good shape for the customer visits that you will inevitably endure. |
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For further information please contact admin@globalregulatory.com or visit www.globalregulatory.com |
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