- Specialty Practices
- Life Sciences
- Validation, Quality & Compliance
Validation, Quality & Compliance
Imbedded VQC talent,- skillfully delivered!
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an integrated extension of your organization
YOH OFFERS INTEGRATED VQC SUPPORT
Yoh’s team of industry veterans are rooted in VQC and known for both their market knowledge and the caliber of their networks. A specialized talent network sets Yoh apart from both our clients and competitors. Our recognized SMEs will effectively shape your talent strategies and delivery within the highly regulated and competitive VQC sector.
Yoh’s team of subject-matter experts have the industry experience to identify talent that will make certain your organization is adherent to regulatory guidelines. Our network of embedded talent excel in these disciplines.
Validation
- cGMP Audits/Gap Analysis
- Cleaning Validation
- Process Validation
- Computer Systems Validation
- Full System Life Cycle Document Development
- VMP Validation Master Plan (VMP)
Quality
- Risk Analyses
- Commissioning (FAT, SAT)
- Integrated Commissioning and Qualification
- Qualification Plans for all Phases of a Life Cycle (DQ, IQ, OQ, PQ)
- Preparation of Qualification Reports
- Establishment of Change Control Processes
Compliance
- FDA Remediation Services
- Regulatory Interpretation
- Meeting with Regulatory Authorities
- Inspection Readiness Standards Assessments
- Gap Assessments Auditing
- Compliance Remediation