Need help on Good Documentation Practice

M

manju.ado

Hello Experts,

Presently I am defining guideline for Good Documentation Practice in my organization.

Could you please share
· Pointers for Good Documentation Practice like
o What and all guideline or procedure should cover?
o Is there any guideline published by regulatory / international bodies (ISO, IEC, FDA etc)
o Any other important points
· Procedure / guideline for Good Documentation Practice for reference?

Your help would be appreciated.

Thank you in advance.

Regards,

Manju
 
A

arios

take a look on ISO/TR 14969. In my opinion it covers what you are looking for when it talks about documentation and records., e.g., how to correct wrong entries.
 

sagai

Quite Involved in Discussions
Hi Manju!
It is very much depends on the regulatory environment you shall comply with.
br
Sz.
 
V

velan26

Hi manju,

Pl. refer the attached file of document control to get the basic about the guidelines of ISO for documentation...


Velan..
 

Attachments

  • 05. Documentation relatedControlRev00Release10_04_2008.doc
    147 KB · Views: 960
K

kgott

Velan26; Can I suggest that you take out the word shall and use the word 'is' or 'are'.

The word 'shall' smacks of militarism, do-it-or-else, is very threatening, implies that it is not currently being done and the only way to get it done is to take the big stick to staff.

The ISO 9001 2008 standard encourages the use of the process approach so therefore this apporach can be incorporated into procedures by describing how, in this case documents are records are controlled. Not 'xyz shall....'
 
Top Bottom