Computer System Assurance
A Smarter Approach to Compliance and Risk Management
Why Computer System Assurance (CSA)?
In the rapidly evolving life sciences industry, ensuring that your computer systems are both compliant and reliable is paramount. Computer System Assurance (CSA) represents a forward-thinking framework that can significantly cut down validation cycles while improving overall quality. Unlike traditional CSV, which often involves extensive documentation and can become a resource-heavy process, CSA emphasizes prioritizing risks based on patient safety, product quality, and data integrity.
Our CSA service goes beyond merely meeting regulatory requirements. It focuses on quality, efficiency, reducing unnecessary documentation, and honing in on what truly matters—ensuring your systems are robust, compliant, and fit for purpose.
Who Benefits from CSA?
If you’re responsible for IT systems within a pharmaceutical, biotech, or medical device company—perhaps as an IT Director, Quality Assurance Manager, or Compliance Officer—you know the pressures of maintaining compliance while managing resources. The shift towards CSA is designed for professionals like you, who seek to reduce the time and cost associated with traditional validation processes, without compromising on quality or compliance.
Our CSA service is especially valuable for organizations navigating the complexities of GxP environments, where a more strategic, risk-based approach to system assurance can lead to significant improvements in both efficiency and compliance.
Our Methodology: How We Ensure Success
At the heart of our Computer System Assurance service are three guiding principles:
- We start with a thorough risk assessment, identifying the areas of your IT systems that have the greatest impact on patient safety and/or product quality.
- Next, we identify aspects of the application that pose the greatest risk to data integrity.
- This allows us to prioritize critical testing and documentation, ensuring that we focus our efforts where they matter most.
- By targeting high-risk areas, we ensure that your resources are focused on the most critical aspects, maximizing impact and efficiency
- This approach prioritizes meaningful testing and documentation while minimizing efforts on lowrisk areas, ensuring that validations are both thorough and resource-efficient.
- Our commitment doesn’t end with initial assurance.
- We provide ongoing monitoring and periodic reviews to ensure your systems remain compliant over time.
- Additionally, we help you implement electronic tools where appropriate, further reducing the manual burden on your team.
Proven Expertise:
- With hundreds of years of combined experience in the life sciences industry, our team understands the unique challenges you face.
- We have successfully implemented CSA for companies just like yours, helping them navigate regulatory requirements and culture shift with confidence.
Our Methodology: How We Ensure Success
At the heart of our Computer System Assurance service are three guiding principles:
- We do not believe in one-size-fits-all.
- Our CSA service is tailored to your organization’s specific needs, focusing on the risks that are
most relevant to your business. - This ensures that you receive a solution that not only meets regulatory standards but also aligns
with your operational goals
- By adopting a risk-based approach, we help you allocate resources more effectively, reducing
costs and accelerating the validation process. - This allows you to bring products to market faster, without compromising on quality.
- From initial risk assessments to ongoing monitoring, we provide full lifecycle support for your CSA
efforts. - Our goal is to be a trusted partner, helping you maintain compliance and ensure system reliability
every step of the way.
Why Embrace CSA?
- Efficiency: CSA streamlines the validation process, focusing on critical areas and reducing unnecessary tasks.
- Regulatory Endorsement: Leading regulatory bodies like the FDA are increasingly supportive of risk-based approaches, recognizing the efficiency and effectiveness they bring.
- Cost Savings: By prioritizing high-risk areas, CSA helps companies reduce the overall cost of system assurance, freeing up resources for other critical tasks.
TESTIMONIALS
Gudrun Finn
Sr. IT Executive, Biotech
Kathy Zagaroli
Senior Director, Quality Control, Kiniksa Pharmaceuticals
Franky Choi
Head of PMO, Large Biotech Firm
Kent Johnson
Associate Director, Clinical Operations, Arcus Biosciences
Igor Komm
Director, System Qualification and Validation, Kiniksa Pharmaceuticals
