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The skills and services that we offer are
the following:
- Equipment Validation
- Computer Systems
Validation
- Cleaning Validation
- Process Validation
- Test Method Validation
- Utilities Validation
- Laboratory Instrument
Validation
- Title 21 Code of Federal
Regulations Part 11 Compliance
- Title 21 Code of Federal
Regulations Part 820 Compliance
- Regulatory Assessments
- Gap Analysis
- Technical and Procedural
Remediation
- Creation, modification and
revision of Technical Manuals, Training Manuals, Administrative
Guides, and Standard Operating Procedures
- Creation of Site Validation
Master Plans, Validation Master Plans, and Summary Reports
- Creation of User Requirement
Specifications, Functional Requirement Specifications and Design
Specifications
- Audits
- Quality Reviews
- Quality Control
Inspections
- Verification of Piping and
Instrumentation Diagrams, Isometric Drawings, and Loop
Sheets
- Document Research, Data
Analysis, and Feasibility Studies
- Creation of Commissioning
Documents, Site Acceptance Tests, Test Plans and Protocols,
Traceability Matrices, Executing Protocols, and Validation
Testing.
Please contact us to discuss your
needs and requirements.
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