by Erin Northington

You’ve been assigned the responsibility of steering your emerging life sciences company towards commercialization. As a leader in IT you need to make calculated and informed decisions to accelerate your journey. Where do you start?

5 tips will help you get organized quickly and intelligently

1. Take the time to assess your current situation. To build anything successfully, it’s important to first assess what you already have and how those resources can be utilized to serve your goals. The foundation for your plan will be found in answering to these questions:

  • What are your current and future business needs and are your systems scalable to these needs?
  • What/where are the various documents and informal procedures and processes?
  • Where are you with your current IT compliance and where do you need to be?

2. Identify critical systems needed and document business requirements. Remember that paper systems are completely fine for starting out! Consider these systems:

  • E-Signatures: Have you notified the FDA?
  • Documents: Where are your different documents stored?
  • Quality (CAPA, adverse events, training, tracking and trending)
  • Inventory management/control
  • Distribution
  • Lot release

After identifying the systems, determine the risk and prioritize them as per your business requirements. 

3. Develop an IT Strategic and IT Compliance Roadmap. While creating your roadmap, make sure to consider these points:

  • Establish your IT Governance and Content Governance policies
  • Plan to be scalable and dynamic 

4. Plan for Cloud. Avoid on-premise solutions as much as possible. If you do need to have on-premise solutions, drive the move to cloud-based solutions in order to reduce support overhead and infrastructure costs. Develop your plans to ensure your cloud systems are GxP compliant.

5. The key to success is to work smart. Utilize resources that provide solutions in a time and cost-effective manner. Remember this:

  • Compliance, Validation, and Auditing as a service can drive your implementation timelines, accelerate clinical trial timelines and help to meet business demands, and allow you to utilize precious headcount for more strategic purposes. 
  • Use Validation and Qualification Accelerator Packages to save time, money, and resources. 
  • Go with best practice approaches instead of trying to reinvent the wheel yourself. 

Recognize that for everything you are trying to do, hundreds if not thousands of people before you have also done the same thing. Keep it simple, and don’t try to do everything at once. Know that an out-of-the-box workflow has been developed by software providers with the best approaches used by many companies. 

Bonus Tip: Why make the journey alone when you can travel with an experienced companion? Connect with USDM to see how we can be a valuable partner on your journey to commercialization.  

Erin Northington

Vice President of Emerging Life Sciences Erin has two decades of experience in Clinical Applications, Business Relationship Management and Project Management. She also has a background in GCP compliance, vendor evaluation and management, systems validation and implementations, as well as process evaluation and improvement. She specializes in managing global enterprise-wide IT implementations of technology solutions.

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