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发表于 2018-7-15 16:04:36
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比较泛泛的文章,毕竟是行为准则。
其中部分要求还是值得思考的:
比如:3.1.4 Each employee will provide annually a signed certification statement confirming that during the past year he/she has adhered to the Code of Conduct for Data Integrity including attestation that he/she has reported to company management wrongful act that raises a question about the integrity of data about which he/she became aware.
3.2.5 In order to verify paper records of GXP activities, the company shall establish and maintain Signature and Initial Logs for employees that work in GXP areas that include a handwritten specimen of the signature/initials of each employee.
3.7.1 The company will establish requirements for employees to notify management if they become aware of data falsification, unauthorized change, destruction, or other conduct that calls into question the integrity of data. The notification requirements including reporting mechanism shall be clearly stated in applicable written policies, standards, procedures, code of conduct, or other documents.
3.8.2 The company shall establish requirements for employees to notify management of known or suspected data integrity problems and shall inform employees that failure to report known or suspected data integrity problems will subject the employee to disciplinary action.
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