Life Sciences Expertise
Audits, Assessments, and Remediation for Life Sciences Organizations
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 Quality Systems Inspection Technique from the U.S. Food and Drug Administration (FDA). This helps to ensure your systems and processes meet regulatory requirements and demonstrate that your Quality System is operating in a state of control.
Our thorough audits identify observations and gaps in systems, processes, and documentation. We then verify that processes are documented and 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 provide visibility into potential compliance and security risks. Our 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 (PAI) audits
- Audit readiness (agency and ISO)
- Audit-as-a-Service
- Drug accountability audits
- Device quality audits
- Internal audits
- Auditor training
USDM can design an audit solution for your organization. We provide single audit services, staff augmentation, or managed services (e.g., Audit-as-a-Service) where our team handles all of your auditing needs.
Our assessment services take a more holistic approach to your regulatory requirements. As with audits, we uncover the gaps and risks to your systems and processes and deliver a report of our findings. Using a variety of techniques during an assessment, we gather pertinent information based on the needs of your organization and provide recommendations for remediation. We then prioritize our findings based on your business needs, resources available, technical know-how, and understanding of the regulations.
Compliance Audits and Security Assessment Services
EU MDR assessment – European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) require a fundamental change in most regulated processes in a medical device company. This includes product identification, European Databank on Medical Devices (EUDAMED) submissions, changes in relationships with economic operators, and QMS changes. USDM’s EU MDR assessment addresses these items with activities and prerequisites to meet Date of Application requirements.
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. It must be accurate and reproducible and have 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-premises and cloud CSV assessments. We can also help you implement the Computer Software Assurance (CSA) approach.
Remediation Support for Life Sciences Companies
USDM’s regulatory compliance guidance assists your organization with agency response, remediation, and preventative change management. After helping to correct and prevent hundreds of regulatory agency risks, we understand that no remediation effort is ever the same. USDM identifies areas of concern that need immediate attention. We have the knowledge and experience in guiding organizational change management, resolving issues with processes and procedures, and addressing gaps in compliance and resources.
Our experts offer remediation support 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
- Support medical device remediation
- Review and update standard operating procedures (SOPs)
- Provide SOP training and organizational change management
- Deliver GAMP training
- Enhance processes to make them more robust
- Remedy QMS inadequacies
- Ensure CSV is adequately tested for the intended use
- Resolve manufacturing process failures
- Solve data integrity issues
Whether you’re a pharmaceutical manufacturer, medical device manufacturer, biotech company, biologics developer, or CRO—or in another government-regulated industry—if you’ve been notified by a governing agency, we can help you with your compliance needs.
Governing 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. It’s more cost-effective to be proactive than to have 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.
Related Services
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.
Quality Management
A well-designed quality management framework, when combined with manufacturing processes and product knowledge, supports increased safety and continuous improvement.
Resources that might interest you
- Bob Lucchesi
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- Various Authors
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- Bob Lucchesi
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- Jim Macdonell
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- Jay Crowley
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USDM Thought Leaders
