Biotechs and organizations alike face immense pressure and scrutiny from the FDA and other regulatory entities. Innovation comes at a great cost, and every pivot subsequently creates delays or complicates project timelines. From compliance to ethics, and everything in-between, the list of responsibilities that life science organizations face is limitless. Whether an organization is comprised of 5, 50, or 5,000 employees, these are equal challenges that can be managed with productive technology.
Gone are the days when infrastructure was behind a static set of walls and controlled by connectivity points. Today, every employee of the organization plays a critical role in cyber security and IT operations. As onsite workloads are accessed by remote connectivity, hybrid workloads become a norm for bench science. Swaths of departments and teams shift to fully remote workforces, and there are endless considerations to be made regarding infrastructure. Computer System Validation (CSV) activities and maintaining GxP compliance add additional layers of complexity, with cloud application providers offering bootless solutions. Some considerations include:
What is the right cloud service?
How do we remotely collaborate?
How do we secure our data?
Do we still need servers?
However, what is the biggest consideration of all? Data. Where are you putting data? How long do you keep the data? And most importantly, how are you securing your data? With data integrity and data security at the forefront, you can more clearly position your infrastructure decisions.
Consistent and empowered IT service is a critical productivity enhancer for any organization's staff. Rapid response and nimble service operations are required to maintain high technology-driven productivity. This solidifies that growth stage organizations with clinical programs and rapid expansion activities require intimate and dedicated support. Service teams must stay abreast of critical activities, like new R&D initiatives, clinical trial preparations and critical quarterly executive meetings. Some considerations include:
What are useful KPIs and metrics?
How do we support hiring 30+ people a month?
What IT do we need for a new facility?
What video collaboration platform do we use?
Best-in-class service is only partly achieved with good support products and procedures. Service for growth stage organizations must be led with empathy and consider the human impact of every situation
Moving the needle past day-to-day activities and into operationalized standards is crucial for scaling and maturing any IT organization. The presence of IT-imposed projects increases in tandem with the rapid growth of an organization. In fact, procedures for accounts that maintain Sarbanes Oxley (SoX) compliance may become of major importance. Routine projects like laboratory expansion or instrument implementation activities require repeatable and positive outcomes. Good process and procedures for repeat projects and maintaining a standard method of working not only enables efficiency but minimizes IT burst work. Some considerations include:
How do we manage IT projects?
What vendors and partners should be involved?
What does IT budget management look like?
Speaking universal project language reduces technology overlap and improves cross-function collaboration. IT may have a need to routinely present to the company, but a project process for this may be well established within the marketing and communications department. Is it better to reinvent the wheel, or globally adopt and expand existing processes?
Our Pharmers bring the right Informed Technology (IxT) to every infrastructure, service, and operational challenge. We partner with industry-leading software and solution providers to deeply understand life science-focused offerings, bringing informed action to every PharmHand interaction. Our focus stays on your current growth needs, whether it’s to match your pace of hiring, physical office expansion, or both. Our focus on deeply familiar support interactions ensures every client's unique support requests are covered. With KPIs defined by your needs and noncommittal consulting subscriptions to support all your professional service needs, you can trust that PharmHand provides the right-size support for every step of your growth journey.