Mergers, acquisitions and divestitures have become much more prevalent in the pharmaceutical industry over the last few years. It seems that recently almost every day we hear news about a mega buyout, or divesting of a business unit to another company.
With this new trend we have seen a steady increase for the need to transfer Quality Data and the need to define the Quality Process for the transition between both organizations.
This process of transfer requires very close coordination between the Quality and Technical teams at both companies. There are several questions that need to be looked at while planning such activities.
- What kind of Quality Agreements are in place between the two companies and what is the timing of those agreement?
- What kind of access will be granted to the Quality System for buying company and for how long?
- What temporary SOPs will need to be created for the transition?
- What are the various Quality Systems that are in play on both sides?
- What data will need to be transferred?
- What will the process be during transfer (I.E. will both systems be running in parallel while the transition happens?
- What state will the records be when transferred, all closed or will they be mid workflow?
Answering these questions and more upfront between both organizations is a key step in starting to plan for a successful Migration. The next step is to start defining out more of the technical aspects of the migrations and again there are several questions to consider.
- Are the systems that each company is using the same; and if so are they similar versions of the application?
- Will all the data be transferred; and if not are the records that need to be transferred easily identifiable?
- Are there integrations to other systems that need to be considered for the migration?
- What format will the transfer be in?
- Are there reports, attachments or other artifacts that need to be transferred as well?
- What level of validation or verification is required for the transfer?
All of the above items will get you started on the right path for a successful data migration. If you would like more information on Process StreamTM’s ACCELERATE Process for mergers, acquisitions and divestitures, please contact us.