Electronic Records and Signatures

Pharmaceutical and medical device manufacturers produce, retain, utilise and share vast amounts of documentation. Documentation (in the form of electronic records) relating but not limited to SOP’s, WI, data, QC results and reports. The system requires login details for each user and users are usually signed off after training or sections of the system. Their login details act as a digital or electronic signature. Once the user has logged in any information recorded is automatically linked to the logged in user. This allows the system to keep track of who is doing what. It is a fully traceable system. No two users have the same details and no one can use the system without authorisation and login details. The system will be backed up and usually off site so as to prevent any data loss in the event of a disaster. The records are essential in case of an issue arising that needs to be fully investigated. As documents (such as SOP’s) are revised and older ones removed from use, they are never destroyed but rather archived so as to provide a document history again in case of the need to return to older versions.


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