Changes to a drug’s product characteristics or licensing will trigger an SPC update. When this happens it is important to make sure that all relevant parties are aware of the changes and receive the revised documentation as quickly as possible. Many companies manage this process manually.
Polisys is a specialist communications company that can manage the SPC update process for you.
Polisys can:-
- Communicate the SPC changes to all relevant parties
- Supply them with the updated SPC documentation
- Get their confirmation that they have received and understood the updated information
- Get them to confirm that they will withdraw all copies/versions of the old SPC
- Provide you with authenticated reports that prove what was communicated, to whom and each individual's declaration
As this is a service there is:-
- NO capital outlay for you - just pay for the service when you need it
- NO IT planning, installation or testing required
- NO software to be installed by users
- NO administration required by you to manage the update process
It's easy for you to use, you just supply us with:-
- The updated SPC document
- A summary of the changes
- The email addresses of the relevant parties and we do the rest
At the end of the communication process we provide you with an authenticated report that is your audit trail of the communication process.
Our services are fast, cost-effective, secure, confidential and can be run without disrupting your business.
