This blog is part 2 of a three-part series titled “The Role of IT in Life Sciences Mergers & Acquisitions.” Read part 1.
How to balance business requirements, employee needs and compliance obligations when integrating systems in a regulated industry
It would be nice if once the paperwork has been signed and the deal is closed, you could hang a sign out front that reads “Merging companies. Back soon.” Unfortunately, operations press on and the race to market continues, so when it comes to integrating systems post-deal, a thought-out plan is essential.
In the world of IT, this plan is often referred to as an integration roadmap. However, when you think of all the responsibilities of your IT systems – regulatory submissions, study management, adverse event reporting, etc. – it can sometimes be hard to see how you’ll get from point A to point B. Here are some tips on how to get started.
Get Your Priorities Straight
One of the biggest hurdles in conceptualizing your integration roadmap is taking an inventory of your needs – and then prioritizing those needs. While in many cases, your business requirements will dictate the chronology of activities, there are exceptions to this rule. For example, the acquired company may have been using a legacy safety system that is about to become unsupported. In this instance, integrating their cases into your company’s safety system may take precedence over other integration activities. You may also find that in some instances more than others an integrated system is essential to integrated operations. For some departments (often finance, for example) working from two systems may prove to be not only inefficient but could create compliance issues if users are forced to manually copy data from one system to another. It’s important that your prioritization method be comprehensive, not only looking at what’s needed to support your bottom line but also to ensure the health and compliance of your systems and the productivity and efficiency of your employees.
Validating Your Processes
Integrated systems in a regulated industry requires checks and balances to ensure no data was unintentionally lost or modified while being moved or copied. Following a merger, acquisition or other business activity, you’ll want to determine your validation methodology for regulated data. No health authority provides a playbook for validation, but auditors – and sponsors – will want assurance that the integrity of your regulated data has not been compromised in shifting data from system A to system B. How do you plan to move the data, and how will it be tested afterward? How can you be sure that adverse events reports will not be corrupted in the process or that all components of a clinical study document were copied to the target system? Your validation methodology should answer these questions with a repeatable and reliable step-by-step testing procedure.
Conclusion
Systems integration should not be an afterthought to your business deal. Be smart in formulating your integration roadmap so you are using your time wisely as you get newly acquired or recently formed business units on their feet. An experienced integration partner like Daelight Solutions can assist in developing an integration roadmap that not only helps minimize business disruption but ensures data integrity and compliance.