When your company is acquiring or gets acquired, there is often the need to divest a site, product or division – a common step for FDA and SEC approval – you need to get data or content (or both) from legacy system/s by the date agreed upon in the Transition Service Agreement (TSA).
If you don’t?
• You could come upon your maintenance renewal date and need to pay hefty fees for a system that you are supposed to be decommissioning;
• You’ll miss the pre-determined date or need to renegotiate the TSA, and the divesting company will charge the receiving company to cover the costs to keep the system running in the meantime; and
• You will have to explain to senior management why the deadlines weren’t met.
If you wait to get off your old systems until a few months before your TSA deadline, that might not be enough time to get everything done.
For example, if your TSA is two years out, you could still miss your deadline just because you waited until near the end because you thought getting off your old system would take less time than it actually will. It’s incredibly frustrating and stressful when something like that happens and it’s entirely avoidable.
If you’ve never handled a GxP migration before, you should know that it’s not just a lift-and-shift. GxP systems are process-bound and require a multi-step approach that often takes many months to execute.
On top of that, there is a lot of “pre-work” required prior to the start of a GxP migration. Companies need to research and select a vendor, negotiate the contract, onboard new people who need their own email addresses and system access – all of which can take an additional two or three months of upfront work that many companies overlook when considering how long the project will take.
If you have a TSA with a firm date set, you need to consider how you’ll be getting off of or decommissioning legacy systems early in your planning process, not when you’re about to go live with your migration. Incorporating it into your overarching plan sooner can help you avoid trouble down the road with both routine processes that take time and unforeseen challenges that could otherwise push back your TSA.
We got a call in mid-September saying, “We need to get off our existing system by the end of the year to meet our TSA date, can you do that?” We understand that the TSA end date is contractual and there are monetary issues if the TSA date can’t be met, but this type of project will definitely take longer to complete than the allotted three months.
After an initial consultation, we uncovered even more things that had not been considered and will delay the project even further. There are processes involved with getting the data from the system over, which usually involve resources and money. There are also processes by the customer and the extract/migration vendor.
This company had not considered the time it would take to onboard the vendor, have them analyze the data from the extract/source and the new target, complete the migration and testing and have the whole solution validated.
After all this was uncovered, the only answer they got was that it could not be done in their allotted timeline. Ultimately, they needed to renegotiate the TSA. Had they started this process much sooner in their planning, they would have avoided some major frustrations.
In the above scenario, the company had allotted three months to get off an existing system and it was not enough. But, what if a company planned for twice that amount of time?
We were contacted by an organization with a dissolving joint venture and a TSA that’s driving the deadline to be off their existing systems in six months. Although this company did have more time, the magnitude of the project caused major issues.
The customer was building out a completely new system with a separate new technology vendor that wouldn’t be ready to receive migrated data for another three months. That other JV partner wouldn’t allow their migration partner to directly access the system and instead had to set up a series of processes with firewalls to allow for the data to be extracted in a way that met regulatory compliance. During the extraction process, it was discovered that the data was not only in a large system, but there was also data in file shares and employee laptops all over the world, all of which had to be migrated to the new system.
On top of the migration requirement with 100% verification, the company did not account for things like budget approvals or implementing the processes that needed to be put in place for them and their vendors.
Contact and contract your migration partner early! Ultimately, there’s no such thing as planning too soon. It’s better to get everyone on board as soon as possible with an agreed-upon timeline and budget. Do NOT wait until it’s too late! The stress on everyone is painful.
Valiance is the leading provider of GxP migration software and services for life sciences with over 150 life science customers. We’re the ONLY vendor in the world whose sole business is the migration of GxP data and content. We work closely with several GxP system providers to successfully deliver solutions.
Migration InSight is our proven data migration methodology to deliver the clarity and confidence traditionally lacking in alternative approaches. We introduce early and thorough planning for decommissioning legacy systems, early data-level analysis and automated 100% post-migration testing. Our TRUseries software was created solely for the purpose of automated migration and migration testing and has been validated by all of our client base.
Contact us to start a project.
Migrations are a complex undertaking and traditional testing approaches often fall short of today’s business and compliance requirements. The ensuing risk can easily result in costly errors. The question is: How sound are your current testing and sampling approaches?