Navigating global regulatory requirements is complicated. USDM can help.

USDM Life Sciences has been conducting audits and assessments for the biotech, medical device, and pharmaceutical industries for more than 20 years. Our team of highly qualified auditors employs the U.S. Food and Drug Administration (FDA)’s Quality Systems Inspection Technique in their auditing approach to ensure that your regulatory requirements are met, and you can demonstrate your Quality System is operating in a state of control.

Our regulatory audits focus on investigating specific systems and processes to ensure they meet regulatory requirements and industry standards. We identify observations and gaps in systems, processes, and documentation. We then verify that processes are documented and being followed, and that GxP records, objective evidence, and data integrity are adequate.

Audit Services

USDM knows that knowledge is security, so our audit reports outline our findings based on decades of industry experience and gaining visibility to potential compliance and security risks. USDM audit services include:

  • Software Vendor Qualification Audits
  • Supplier Qualification Audits (CMO, CRO, API, Supply Chain, Distributor, Laboratory, Testing Services
  • Mock Audits (FDA, EU)
  • GxP Audits (GCP, GLP, GMP, GPV, GRP)
  • Mock Pre-Approval Inspection Audits (PAI)
  • Audit readiness (Agency and ISO)
  • Auditing-as-a-Service
  • Drug Accountability Audits
  • Device Quality Audits
  • Internal Audits
  • Auditor Training

We provide single audit services and staffing augmentation to supplement your current audit team, or managed services, (i.e., Auditing-as-a-Service) where we provide a team of auditors to handle all your auditing needs. USDM can design an audit solution to meet your needs.

Our assessment services take a more holistic approach to your regulatory requirements. Just like audits, we uncover the gaps and risks to your systems and processes and deliver a report of our findings. During an assessment we may use a variety of techniques to gather pertinent information, based on the needs of your organization. We provide recommendations for how to remediate those findings and prioritize them based on your unique circumstances: your business priorities, your resources available, your technical know-how, and your understanding of the regulation.

USDM provides remediation services to assist in addressing the findings. See what the difference could be.

Compliance and Security Assessment Services

  • EU MDR Assessment – EU MDR and IVDR regulations require a fundamental change in most regulated processes in a medical device company (i.e., product identification, EUDAMED submission, changes in relationships with economic operators, QMS changes, etc.). USDM’s EU MDR assessment addresses these items with a detailed orientation of the sequence of activities and prerequisites to meet the Dates of Application. 
  • IT Assessments – USDM assesses your IT infrastructure, processes, documentation, and the roles and responsibilities of your IT team to ensure your technology and technical processes are compliant. 
  • Data Integrity Assessments – Data is your most valuable intellectual property (IP). Data must be accurate and reproducible, with controls in place to keep it that way.
  • Quality Management Assessment – The quality system is the heart of what enables your business to thrive, and you can’t afford to have gaps that jeopardize your compliant state.
  • CSV Assessments – Computer System Validation assessments ensure your systems and applications are GxP compliant. We offer both on-prem and cloud CSV assessments. We can help you implement the FDA’s recommended Computer Software Assurance (CSA) approach.

Compliance Audit Case Studies


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Additional Resources

Audits and Assessments FAQ

  • What is a software vendor audit?

    A software vendor audit in the life sciences industry is an audit of the software companies’ products, services, and processes to ensure the technology aligns with their customer’s regulatory agency requirements. The audit typically reviews the vendor’s quality systems and software development process, including documented evidence such as procedures, tests, and records.

  • Why audit suppliers and vendors?

    Life sciences companies are required to qualify critical vendors such as drug and component manufacturers and key suppliers. The list also includes software vendors who supply software solutions for critical processes within the drug and medical device manufacturing process.

    This qualification ensures that the vendors have consistent software and quality processes in place and that they are under a state of control that is satisfactory to the regulated demands of the life sciences industry. USDM’s Cloud Assurance service includes audits for the respective SaaS vendor like Salesforce, Box, DocuSign, Oracle, etc.

  • Why should I conduct a mock audit?

    Mock audits are usually performed well in advance of an actual agency or registrar audit. They allow you to self-identify any gaps in your processes and procedures that are audited by the FDA and other regulated agencies. Types of mock audits include pre-approval inspection (PAI), ISO, and cGMP audits.

  • What is 21 CFR Part 11 and GxP auditing?

    Title 21 CFR Part 11 of the Code of Federal Regulations (CFR) establishes FDA regulations on electronic records and electronic signatures (ERES). Part 11 is a law that ensures that companies implement good business practices by defining the criteria under which electronic records and electronic signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. 

    The goal of Part 11 audits is to ensure that life sciences companies are implementing the required controls to ensure the safety of users of their products. GxP refers to “good working practices” in various areas of the life sciences industry. They include manufacturing, laboratory, clinical trials, etc. The audits are conducted against these practices to ensure compliance.

  • How do medical device, biotech, and pharma companies prepare for IT audits?

    With more than 20 years of life sciences experience and former FDA auditors on staff, USDM is the leading consulting firm to help you prepare for audits in the biotech, medical device, and pharmaceutical industries. Our experience enables us to deliver efficient processes that save you time and money. We provide single audit services, staffing augmentation to supplement your current audit team, and managed services (i.e., Auditing-as-a-Service), where we offer a team of auditors to handle all your auditing needs.

  • What is the FDA’s Pre-Approval Inspection (PAI) Program?

    A pre-approval inspection (PAI) is conducted to substantiate to the FDA that a manufacturing facility named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. USDM conducts PAI-readiness audits and mock PAI audits to improve your probability of success.

  • How can I be ready for a regulatory audit?

    You can find audit checklists online, but we highly recommend using a third party, like USDM, to get an unbiased, expert opinion on your audit readiness. This will help ensure that processes are documented and followed and that GxP records, objective evidence, and data integrity are adequate to pass the audit inspection. It also helps to identify any areas that require remediation if you are not audit ready.

  • How can I make audits more efficient, get the proper training, and be more prepared?

    USDM provides audit readiness training for anticipated and scheduled agency and registrar audits. Our team of experts can tailor a training program for your specific needs and help prepare you for an audit. These training sessions can be conducted both on-site and remotely.

  • Drug Accountability in Clinical Trials

    Drug accountability is a serious issue. The FDA uses various categories in determining the seriousness of the deficiencies in clinical trials. Examples include clinical study documentation consistency, record completion, and process validation for the intended use. We often see issues with negligent documentation, poor recordkeeping, or lack of training that can be corrected and resolved with training and guidance. USDM can help with employee training and consistency to ensure drug accountability records don’t jeopardize your clinical study.

  • Auditing the Quality of Medical Devices

    Medical device companies often have difficulties adhering to schedules for auditing and trusting the quality of their internal audits. USDM can help you stay on track and pass your audits and make it a natural flow of your business by conducting audits to ISO 13485 standards and general quality and regulatory compliance standards in the medical device industry.

  • Comprehensive Audit Services

    Are you behind on your internal auditing requirements? Life sciences companies often face bandwidth issues that cause audits to be delayed or cancelled. USDM can manage your internal auditing schedule and ensure you are prepared. We have conducted many internal audits for organizations facing such resource challenges. Our services are comprehensive and offer flexible delivery options to meet your needs. Should we find issues, we can help with remediation or assess your next steps.

     

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
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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