From methodology development through end-user training, USDM ensures that your systems are compliant. Our validation best practices and test automation capabilities significantly decrease your implementation and validation time.
 
Whether you are still using the traditional CSV approach or ready to take the first steps to a more modern CSA approach to improve your quality and efficiency, USDM can help!
 
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Computer System Validation for Life Sciences GxP Environments

USDM has experience qualifying, verifying and validating the myriad systems, equipment and processes that are found in most life sciences GxP environments, both on-prem and cloud-based. Our expertise includes, but is not limited to:  

GxP Collaboration for Emerging Companies

Pre-commercial startups are faced with so many competing demands and priorities and have very unique needs. Often these rapidly growing companies lack the resources or GxP expertise to move full speed ahead. USDM has helped hundreds of emerging companies with understanding global regulations and executing a technology strategy to chart a path to success.

Additionally, USDM can provide related services such as: Have a question about how we can work with your specific GxP system setup?
 
Fill out our contact form with your system requirements and we can review them.
 

What is USDM’s Computer System Validation (CSV) methodology?

 
Our current methodology aligns with GAMP (Good Automated Manufacturing Practice) best practices and includes the following: 
  • Vendor Audit
  • Validation Plan
  • Part 11 and Annex 11 Assessments
  • Risk and Impact Assessments
  • User Requirements and Functional Specification
  • IQ/OQ/PQ/UAT Protocols and Test Scripts and Execution Assistance
  • Traceability Matrix
  • Administration, Use and Operation SOPs
  • Business Process SOPs
  • Validation Summary Report 
 
Specific documents and deliverables will depend on GAMP category. Contact USDM today to discuss your specific CSV needs.
 

Computer Software Assurance (CSA) FDA Compliance

To harmonize with international standards, the FDA's Center for Devices and Radiological Health (CDRH) plans to release a new draft guidance, “Computer Software Assurance for Manufacturing, Operations, and Quality System Software,” that aligns with the current quality systems regulation ISO 13485. With the FDA changing focus from compliance to quality and encouraging the use of automation and new technologies, USDM is already modernizing and practicing a more streamlined approach to CSV and in the process of updating our Cloud Assurance methodology to include a true, risk-based, CSA approach. We can help you develop your CSA approach too!
 

What is Computer Software Assurance (CSA)?

In 2011 the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, a new program that identified barriers in the current Validation of Software in Medical Devices guidance (released in 2002). The current guidance focuses on software, which is an integral part of the medical device but does not clearly address the many software systems that support the quality of a medical device. The CDRH is working on a new draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” that will allow manufacturers minimize their existing computer system validation (CSV) efforts and documentation burden and focus on more efficient approaches, including automation, to improve their overall process and product quality. This guidance is founded on a true risk-based approach systems assurance, which should be considered when deploying non-product software systems.
 

Computer Software Assurance (CSA) Highlights

  • Guidance on FDA's A list for release in 2021
  • CDRH Guidance, in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)
  • Non-product quality system software (i.e., ERP, LIMS, LMS, eDMS, and QMS applications as well as software tools)
  • Principles and approaches are applicable now to all regulated organizations
Download our PDF overview of CSA here.
 

Why is the FDA introducing Computer Software Assurance?

As part of their Case for Quality program, one of the top priorities for the FDA's medical devices center, the FDA identified several barriers with CSV:
  • Complex, confusing, hard to use, risk-based approaches
  • Too much focus on documentation for the auditor, creating significant compliance burden
  • Lack of clarity on how much testing is enough and where to focus that testing
  • The FDA believes the use of automation, information technology, and data solutions throughout the system life cycle can provide significant benefits to drive enhanced quality and safety, thereby reducing patient risk

How is the FDA guiding the CSA?

  • By defining indirect versus direct systems
  • By identifying acceptable approaches to indirect and direct system validation
  • By focusing on a risk-based approach using critical thinking to spend more time developing a methodology appropriate to the risk of the system, focus on testing of high-risk systems and functionality, and less time documenting
  • By training inspectors to focus their review on the higher-risk activity and the critical thinking behind the chosen methodology

What are the benefits of a CSA approach?

As part of their Case for Quality program, the FDA participated in several pilot programs that consistently delivered the below results;
  • Improved quality and efficiency
  • Up to 90% decrease in test script issues
  • Significant testing overhead reduction
  • Utilize vendor assurance activities
  • Maximized use of CSV and expert resources
  • Capability to deliver value faster

How can USDM help?

CSA Education and Training
USDM can help teach and mentor your teams on CSA principles and how to apply critical thinking to your process CSA Assessments
USDM can assess your CSV process and recommend CSA changes based on your quality of documentation, testing, SOPs/WIs, testing, use of automation, performance on audits, etc.
  • Evaluate your current CSV process for quick wins and longer-term improvements
  • Prioritize recommended changes based on business justification
  • Improve your vendor qualification process
  • Build a CSA roadmap based on your business priorities
CSA Development and Methodology
From vendor selection to methodology development to end-user training, USDM can transform your CSV into a CSA approach and help drive adoption across your organization
  • Implement fast-start improvements to your processes
  • Develop and execute pilot programs
  • Deliver complete overhauls to your CSV processes and procedures
Cloud Assurance
USDM can manage your entire CSV or CSA process and deliver an end-to-end GxP compliant managed service, including the continuous maintenance of all your cloud vendor releases
  • Assist with cloud vendor selection and RFP process
  • Manage cloud vendor assurance, vendor qualification, and maintenance of new releases
  • Leverage automated regression testing
USDM is on the cutting edge of technology and compliance and we are watching the FDA’s Computer Software Assurance guidance closely. We already have progressive solutions in place and can save you significant time and money on your validation programs. Please contact us to discuss your unique challenges today.

Additional CSA References:
 
Areas of Focus
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Thought Leaders

Leading experts in every Life Sciences field

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Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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