Focus Areas
- FDA Warning Letter
- Post Market Surveillance
- Clinical Compliance
- Validation Engineering
- Manufacturing Engineering
- Product Development
- Software QA
- FDA Warning Letter/Remediation Efforts
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Validant has assisted several of our major clients with quality improvement efforts driven by regulatory concerns.
We have successfully executed remediations of processes, equipment and test methods for several major device and pharmaceutical manufacturers.
We provide project managers, SME's and individual contributors.
- Post Market Surveillance
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- Developing and monitoring systems to assure potential product complaint investigations are appropriately investigated and concluded.
- Preparing complaint records, customer letters, MedWatch reports, vigilance reports, and applicable complaint handling documents.
- Managing data to assure thorough and accurate complaint records are filed and linked to risk management systems.
- Auditing closed complaint files for thoroughness and accuracy.
- Clinical Compliance
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Validant clinical compliance professionals conduct investigational site and trial master file audits within the US and globally, in order to help our clients verify compliance with Good Clinical Practices (GCP), internal SOPs, and applicable regulatory/FDA requirements. Our clinical auditors have a comprehensive working knowledge of the clinical research process including the FDA Code of Federal Regulations, ICH-GCP Guidelines, ISO 14155-1,2 and familiarity with human anatomy, physiology, and medical terminology.
- Validation Engineering
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Validant has participated in validation remediation efforts for several major device and pharmaceutical manufacturers.
Functional areas include:
- Equipment Validation
- Process Validation
- Test Method Validation
- New Facility Validation
- Manufacturing Engineering
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Validant engineers have led successful projects in the areas of new facility qualifications, and remediation of existing facilities and utilities to comply with current regulatory standards. In addition to the facilities projects, Validant engineers have also led several major process equipment validation efforts - both existing processes and capacity expansion projects.
We have experts in critical systems, utilities, and sterilization who bring immediate and measurable results.
- Product Development
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Validant engineers have led a variety of medical device product development efforts, incorporating all of the required design control practices along with active risk management programs.
We have helped our client to bring products from concept to commercialization in a timely and compliant way. Our engineers are experts in the regulatory requirements governing new product development and market launch.
- Software QA
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Validant has led enterprise-wide software application projects, process automation projects, and LIMS implementation and validation projects for several Fortune 500 clients. One of our clients entrusted Validant to lead what they are calling a transformational program - integrating the historical data from a variety of stand-alone and bespoke systems into an enterprise-wide configurable business process application. The project is on budget and ahead of schedule.
