Hello All,
Going further with tech/RA docs retention topic (MDR)... Our QMS electronical system keeps documentation in obsolete status (marked as "Obsoleted" in the database and shown visibly red on the printed version, across the document).
For ongoing productions our documents, once approved, have marked status: Active. When getting new revision, previous dispplayed is being marked with: History.
When we are dropping partial portfolio, we set up documents in the system as: OBSOLETED (but only after last produced batch in reaching its expiration date). Ofcourse retention period is kept, archiving as required - with this obsoleted mark.
Now questions:
A- is it really necessary to wait with marking documents as *obsoleted *untill expiry date? We talk here about: DoC, technical docs package, Post market surveillance, CER, Safety sheet etc.
B- Some discontinued products may have larger stocks build and long shelf life. During its life cycle on the market, license may need to be renewed. Are documents in "Active" status needed for dropped products?
C- PMS review: does it require "Active" (thus periodically reviewed) documents even for discontinued items (but still existing/being sold on the market)?
D- Authorized body may call for DoC even for Class 1 product. Will they accept document with Obsolete status? or it must be kept in controlled status?
Great thanks for the disscusion here...
K.Z
Going further with tech/RA docs retention topic (MDR)... Our QMS electronical system keeps documentation in obsolete status (marked as "Obsoleted" in the database and shown visibly red on the printed version, across the document).
For ongoing productions our documents, once approved, have marked status: Active. When getting new revision, previous dispplayed is being marked with: History.
When we are dropping partial portfolio, we set up documents in the system as: OBSOLETED (but only after last produced batch in reaching its expiration date). Ofcourse retention period is kept, archiving as required - with this obsoleted mark.
Now questions:
A- is it really necessary to wait with marking documents as *obsoleted *untill expiry date? We talk here about: DoC, technical docs package, Post market surveillance, CER, Safety sheet etc.
B- Some discontinued products may have larger stocks build and long shelf life. During its life cycle on the market, license may need to be renewed. Are documents in "Active" status needed for dropped products?
C- PMS review: does it require "Active" (thus periodically reviewed) documents even for discontinued items (but still existing/being sold on the market)?
D- Authorized body may call for DoC even for Class 1 product. Will they accept document with Obsolete status? or it must be kept in controlled status?
Great thanks for the disscusion here...
K.Z
