Internal & Vendor Audits
We provide auditing to ensure that either you or your Vendors could stand up to a Regulatory Audit regarding the validation of computer systems, computer applications, clinical trials and regulated manufacturing areas. This includes the review of systems and their associated documentation for compliance with current interpretations of Federal Regulations and best industry practices.
Interphase Systems knows audit preparation and compliance is critical to any business. Many clients have asked for our assistance to confirm their infrastructure is compliant with all business and government regulations. We begin this process by looking at the client’s current environment and the policies and procedures that are in place. We then use this as a template to help build their new infrastructure and standard operating procedures to ensure all policies and practices are upheld and compliant.
We not only provide our clients with a solution, but also can provide a new set of business practices that include checks and balances for future audits. The more prepared a client is, the less time, money and effort is spent on trying to retrieve resources and data that can very easily be ready with the right plan and tools in place.
Interphase Systems can help you prepare for an audit or help you to audit your Vendors.
Interphase Systems can help you to:
- Anticipate discussion points and potential questions
- Organize your validation documentation that is available
- Help you to identify gaps that you may have with your documentation
Interphase Systems Audit Offerings
| Service Offering |
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| Get an independent assessment of your quality and regulatory readiness.
Interphase Systems will conduct a due-diligence, in-depth audit and evaluation of current GxP, and all pertinent predicate rules under the US FDA Title 21 Code of Federal Regulations, along with auditing of policies, standards and procedures. During the audit Interphase Systems will be able to evaluate your company’s level of GxP preparation and readiness.
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Clinical Trials
- GCP Investigator site audits in preparation for regulatory submission
- CRO audits to initially qualify vendors and later verify ongoing performance
- GLP audits of studies for the QA statement in the final report and of GLP vendors to qualify and verify performance
- QC evaluations of final study reports prior to regulatory submission
- "For-cause", "Due-Diligence", Mock FDA Audits, and (fraud and abuse) investigations
Internal Quality Audits
- Compliance GMP, GCP, GLP, QSR and/or Part 11 Systems Audits
- Quality Assurance Audits - Quality System Audits - Part 820
- SOPs, Quality Assurance and Standards Audits
- Equipment Validation Documentation Audit
- Software / Systems Validation Audits
Vendor Audits
- Contract Research Organizations (CROs)
- Software Vendors
- Contract Manufacturer Organizations (CMOs)
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