Life Sciences Expertise
Audits, Assessments, & Remediation for Life Sciences Organizations
USDM help can help you navigate the complexities of GxP regulatory requirements globally.
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.
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)
- 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.
Remediation Support for Life Sciences Companies
USDM’s regulatory compliance guidance can help your organization with agency response, remediation, and preventative change management. USDM has helped correct and prevent hundreds of regulatory agency risks and no remediation effort is ever the same. USDM can identify areas of concern or address an existing concern that needs immediate attention. We have the knowledge and experience to guide you in organizational change management (OCM), resolving issues with processes and procedures, and addressing gaps in your compliance and resources.
Our experts remediate for medical device companies and other life sciences companies found in violation of:
- 21 CFR Part 11
- 21 CFR Part 210/211
- 21 CFR Part 820
- EU MDR
- EU GMP Annex 11
- ISO 9000
- Quality System Regulation (QSR)
- Unique Device Identification (UDI)
- And many other global regulations
Non-Compliance Remediation Service
USDM ensures that your processes and procedures are in compliance with global regulations and industry best practices. Examples of our remediation work include:
- Correct and update medical device design controls
- Medical Device Remediation
- Review and update standard operating procedures (SOPs)
- Provide SOP training and organizational change management
- Provide GAMP training
- Enhance process weaknesses to make more robust
- Remedy QMS inadequacies
- Ensure CSV is adequately tested for the intended use
- Improve manufacturing process failure
- Solve data integrity issues
Whether you’re a pharmaceutical manufacturer, medical device manufacturer, biotech company, biologics developer, CRO, or in another government-regulated industry, if you’ve been notified by a governing agency, we can help you with your compliance needs.
Government Agency Remediation for Life Sciences
At USDM, we have perfected our approach to remediation. These are some of the steps we take to resolve your compliance issues:
- Analyze observations and findings and discuss them with key stakeholders and SMEs
- Develop an action plan to correct and prevent future issues, prioritize actions, and set a timeline
- Define critical results and metrics to measure success against the action plan
- Execute the plan, track progress to critical metrics, and deliver change management and training
- Share ongoing reporting with the customer to ensure alignment, accountability, and progress
If you have an observation or a potential problem, USDM can assist in a resolution before it becomes a bigger issue; being proactive is more cost-effective than having an agency require a fix. Whatever your remediation needs – internal observation, 482 notice of inspection, form 483 from the FDA, warning letter received, or Consent Decree issued – contact USDM. We also help with general clinical regulatory consulting and medical device clinical consulting.
Get your questions answered by former FDA auditors.
USDM Cloud Assurance
USDM Cloud Assurance is a managed service that offloads your vendor release management and maintenance of ongoing system updates, patches, and changes.
Validation & Qualification
We have extensive experience qualifying, verifying, and validating the many systems, equipment, and processes found in GxP environments, on-prem and cloud-based.
A well-designed quality management framework, when combined with manufacturing processes and product knowledge, supports increased safety and continuous improvement.