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Record Legibility and Initials - Signing Records with sometimes Illegible Initials

Jim Wynne

Jim Wynne

Staff member
Admin
#11
#11
Re: Record Legibility and Initials - Signing Records with sometimes Illegible Initial

elkinsn said:
Hello everyone,

Does anyone have thoughts or recommendations on how to handle people signing records with their (sometimes illegible) initials? Especially when the 9001 standard specifically states that records must be "legible". They are ultimately identifiable (if you ask around to the people who regularly see them) but I'm not sure if that meets the standard. Thanks for any help!

Nathan
Click to expand...
While the 9001 requirements for legibility of records might not apply directly to signatures, if you have a requirement for only authorized persons to sign documents and you can't link the signatures to the authorized person(s), you have an evidence problem. Why not just require people who sign/initial documents to also print their names?
 
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elkinsn

#12
#12
Re: Record Legibility and Initials - Signing Records with sometimes Illegible Initial

Thanks for all the great suggestions everyone, I'll take all that I can get! :)

Nathan
 
jkuil

jkuil

Quite Involved in Discussions
#13
#13
Re: Record Legibility and Initials - Signing Records with sometimes Illegible Initial

In order to meet good clinical practice requirements it is required to maintain a signature log per clinical study. It authorises employees to sign records (Case report forms) as it links the signature/initials to a specific authorised activity. For authorisation purpose the log is signed by the responsible investigator.

Generally a signature log is usefull to link record signing to individual training records and authorisations. BTW your initials/signature should be unique and difficult to copy (i.e. illegible) for authentication purpose, but consistent throughout the records for the link to the signature log.

The only option I know of is to write your full name next to your signature or legible initials next to your unique personal initials.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
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#14
#14
Re: Record Legibility and Initials - Signing Records with sometimes Illegible Initial

ISO 9001 has a requirement that the person authorizing the release of product to the customer must be identifiable. If the initials are untraceable to a person, then that requirement is not complied with.
 
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