What is your level of cloud readiness and maturity?
Find out with an IS Compliance Health Check from USDM.
The short version
- What it is: an evaluation of your IS compliance, cloud readiness, and process efficiency across people, processes, and technology.
- How it adapts: can be run for traditional Computer Systems Validation (CSV) or modern Computer Software Assurance (CSA).
- What you get: a baseline maturity state, prioritized improvement areas, and a high-level roadmap to IS compliance maturity.
- Two levels: a complimentary high-level assessment and a deeper paid assessment.
Whether the pandemic had your company fast-tracking cloud adoption or you were already in the process of digital transformation, how would you rate your current level of cloud readiness or maturity? Was your move to the cloud an easy transition or did it have an impact on your operational continuity? Cloud readiness relies heavily on the capabilities of your in-house IT team. Skills, experience, tools, and the ability to focus on data migration while transitioning to the cloud are critical to your organization’s success.
Your company’s process efficiency is a big contributor to business success. If your people or your technology are not at peak performance, what will you do to fix them? Content orchestration gives you the bigger picture of digital activity across your organization and ensures greater accessibility, collaboration, efficiency, and compliance.
IS Compliance Health Check
USDM’s exclusive Information Systems (IS) Compliance Health Check evaluates the state of your IS compliance, cloud readiness, and process efficiency, and gives you an overall analysis of your people, processes, and technology. After completing the health check, USDM helps you build a high-level roadmap to achieve IS compliance maturity.
- The assessment can be performed for a traditional Computer Systems Validation (CSV) or a more modern Computer Software Assurance (CSA) methodology.
- It focuses on people, processes, and technology and assesses the level of maturity in your organization as it applies to business processes, IT strategy, and compliance.
- It is designed to scope and plan a more detailed strategy and roadmap.
- It is an indicator of your state of regulatory compliance and IS efficiency, including alignment with 21 CFR Part 11 expectations for electronic records and signatures.
There are two levels of assessment: complimentary and paid. We offer a complimentary assessment because we believe an IS Compliance Health Check is vital to your operational success. We are confident this high-level view will prove valuable to diving deeper into your business processes.
What the health check measures
- People: the skills, experience, and capacity of your IT and quality teams to operate and validate systems in the cloud.
- Processes: the maturity of your business processes, IT strategy, and compliance practices, including your CSV or CSA approach.
- Technology: the state of your information systems, cloud readiness, and the controls that keep them in a validated, compliant state.
If your people or your technology are not at peak performance, the first step is knowing exactly where the gaps are — and what to fix first.
Benefits to Your Organization
- Reveal opportunities to improve compliance maturity
- Enable prioritization, quick wins, and critical remediation
- Create or substantiate a roadmap with expert analyses
How It Works
The IS Compliance Health Check is comprised of a few simple steps:
- Create an account on this website.
- Go to the IS Health Check.
- Fill out USDM’s assessment questionnaire.
- USDM emails you a custom report with your baseline maturity state, areas of improvement, and a high-level roadmap. We will provide a Summary Report with observations and recommendations along with a roadmap for future IS maturity and compliance. The chart above is an example of information included in the summary.
Sustaining that maturity over time — not just reaching it once — is where ongoing programs like Cloud Assurance and disciplined validation lifecycle management keep your systems audit-ready as they evolve.
FAQ: IS Compliance Health Check
What does the IS Compliance Health Check evaluate?
It evaluates the state of your IS compliance, cloud readiness, and process efficiency across three dimensions — people, processes, and technology — and assesses maturity in your business processes, IT strategy, and compliance.
Does it support CSV or CSA?
Both. The assessment can be performed for traditional Computer Systems Validation (CSV) or the more modern Computer Software Assurance (CSA) methodology, depending on your environment and goals.
Is there a free version?
Yes. USDM offers two levels of assessment: a complimentary high-level health check and a deeper paid assessment for organizations ready to dive further into their business processes.
What do I receive at the end?
A custom Summary Report with your baseline maturity state, observations, recommended areas of improvement, and a high-level roadmap for future IS maturity and compliance.
How does the health check connect to a broader compliance strategy?
It is designed to scope and plan a more detailed strategy and roadmap, giving you an indicator of your regulatory compliance and IS efficiency that can feed into validation, data integrity, and continuous compliance programs.
Related Resources
- Video: Your Compliance and Technology Today
- Blog: Rapid Application Migration
- White Paper: Regulated GxP Workloads in the Public Cloud