At Solutions2Projects we believe that there is power in leveraging technology to optimize business performance and accelerate growth. We also believe that the IT technology and system strategy should be aligned with the corporate strategy to reduce time to market, reduce unnecessary costs, and improve the bottom line. We understand that every company is different and at varying stages on the regulatory and organizational evolution pathways, requiring different levels of formalized processes and tailored approaches.
We tailor our services to meet your unique, business needs.
Solutions2Projects provides the following services to biotech, medical device, diagnostic, emerging digital health, and other technology companies:
IT Strategy Development
As our clients are developing their corporate, clinical and regulatory strategies, we at Solutions2Projects work with our clients to identify technology needs and create an IT strategy to align with their corporate strategies and timelines. This allows our clients to effectively plan for headcount and financial resources to support their selections and implementations to meet their overall business and compliance needs.
Computer Validation Advisory
The first step in validating an IT related system is with a risk assessment to determine whether the system needs to be validated and the extent of the validation effort. This is where Solutions2Projects comes in to help our clients define the best strategy before selection and implementation. We then provide time-proven guidance and templates throughout the validation cycle, tailoring to our clients’ risk tolerance and intended use.
System Selection Advisory
Why be at the whim of your vendors during system selection when you can define your requirements and ensure you get the best possible solution based on your company’s needs and corporate direction? Solutions2Projects works with its clients to identify their true business needs, ensures alignment with their corporate strategies and timelines, and provides guidance to tailor their selection process to meet their specific and unique business requirements.
IT Vendor Audits
In support of a client’s compliance and validation strategies, Solutions2Projects performs vendor audits of third parties including SaaS, externally hosted providers, software vendors, CROs, and other third party service providers. Solutions2Projects works with clients to establish the desired audit objects based on generally accepted best practices, 21 CFR Part 11 and Annex 11.
IT Compliance Advisory
Solutions2Projects believes in right-sizing each client’s IT compliance strategies and system approaches to meet their specific compliance objectives and risk tolerances. At Solutions2Projects we do not believe in a one-size-fits all approach. We work with our clients to develop and modify operational IT practices in support of FDA regulations (including 21 CFR Part 11 and validated systems), Sarbanes-Oxley (SOX), GDPR, and other compliance requirements.
Digital Health Advisory
Digital health is a new and rapidly-growing sector with evolving compliance requirements. Solutions2Projects recognizes the unique nature of this sector and provides strategic and compliance guidance to help our clients navigate this uncharted territory.