Question: As a manager of a small testing facility that only performs 1 0 - 1 2 regulated studies per year, you want to meet GLP
As a manager of a small testing facility that only performs regulated studies per year, you want to meet GLP requirements for archiving your paper raw data. However, your resources are limited To provide the maximum degree of control and security, which of the following solutions would be most GLPcompliant and enhance the quality system, while being affordable and practical at the same time?
None of these solutions are GLPcompliant because an archive must be a separate, dedicated, and locked room within the facility.
Decide to remove filed records from the facility entirely and set up a locked file cabinet in your residence. Have the locks replaced and create a standard operating procedure SOP using a paper index to record the logging inout of the contents.
Decide not to have an internal archive at all, but instead set up a contract with a professional archival service.
Decide to purchase a used, fireproof filing cabinet, have the locks replaced, and create a standard operating procedure SOP using a paper index to record the logging inout of the contents.
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