How to manage Sop's & other quality documents after business transfer

mpfizer

Involved In Discussions
#1
The company I work for recently had a business transfer agreement with a 30 plus year old medical device company , do we need to change the SOP numbers or just retain all the old sop's and drawings and other quality documents . As we were not the original company to design and validate the products and all the documents have name of old company and signatures of people who may have left ,how do we address this issue .
Should we continue with the old documents without revision in name of old company or do we revise the old documents and put our name and our new staff signatures.
Any help on how to handle the quality documentation , Sop's , drawings etc would be highly appreciated .

Thanks

michelle
 
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Thee Bouyyy

Quite Involved in Discussions
#2
One year back we had a similar circumstance. We had chosen to utilize the old organization's name, logo, SOPs, drawing and different records for some time period. To stay away from any contentions with the auditor, as a proof we written the same thing in our management review document and Quality manual. Auditor accepted it.

In quality manual prelude we have composed this way, "This manual is the property of the New organization. The progress period for moving essential procedures/drawings/WIs/other documents from old organization to new organization will be done inside two years from 21st October 2021. It is chosen not to change any procedures/drawings/WIs/other documents just for name change.

You will get adequate time span to move old organization's archives to new one without getting compressed.
 

shimonv

Trusted Information Resource
#3
It depends greatly on the circumstances, like do they have products in the field? are they currently selling products or did they announce end-of-life? what certificated and regulatory clearances do they have to their name? Will the old business name cease to exist? You need to have the broad picture before jumping to a pool full of old records.
 

Tagin

Trusted Information Resource
#4
Should we continue with the old documents without revision in name of old company or do we revise the old documents
My thought is to retain ALL the old documents as records AND create new process documentation (whether that is relabeling of old SOPs or creating fresh SOPs). Creating these new process docs would take time, so as long as the old SOPs are still appropriate, aside from name/numbering/etc. then maybe you could have an entry in your QMS (maybe in QMS manual?) that allows these old SOP docs to be used in the interim. Essentially, some explicit statement of approval in the current QMS that these "imported" SOPs are approved for use, at least in the near term.
 
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