Evidence for Preventive Action & Early Warning Vigilance procedure

Valli

Involved In Discussions
#1
Can you please guide me on the following the following points.

Dear All,

Can you please help me with the following queries.
  1. Are there any template or standard practice for documenting Preventive action? What type of documented information we should produce as evidence. We are performing , but failing to understand the procedure to document.
  2. Does CAPA format /template should it contain or not Preventive action plan as part of CAPA Format?
  3. Early Warning: We are adopting Vigilance procedure as per MEDDEV guideline. Is it sufficient ?
  4. Can you please share the GHTF guideline about Early Warning?
Thank you,

Regards,
Valli
 
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Peter West

#2
Re: Evidenace for Preventive Action & Early Warning

Hi Valli

I can't comment on points 3 and 4 but for 1 and 2 I would be wary of subscribing to a standard template that is on the web somewhere. They offer good ideas on content and layout but ultimately whatever forms you use and data you collect should be specific to your own company and processes.

Just a tip.

Thanks

Peter
 
P

Peter West

#3
Re: Evidenace for Preventive Action & Early Warning

On a more helpful note look here http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=1&criteria=capa for some examples of capa forms.

Hope that helps a bit. There is quite a lot of information stored on the cove. I suggest you use do a search and read through a few of the other threads which will no doubt turn up more guidance and advice. The post attachment list at the top of the page provides good examples of documents others have provided.
 

Valli

Involved In Discussions
#5
Re: Evidence for Preventive Action & Early Warning

Dear All,

Thank you for your response. I have gone clove search result, but could not conclude how to present the result.

Dear Jo,

Thank you, excellent format. Your sample format gives an idea and to start with.

Best Regards,
Valli

Hi Valli,

I'm not sure about the Early Warning process, but have attached my procedure for corrective and preventive action, together with the associated PAR form. I hope this helps.

Jo
 
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