Process and Software Verification and Validation
The focus of Process and Software Verification and Validation is to ensure that products and software meet requirements. The goal of a verification and validation project is to provide cost effective guidelines and methods in order to meet FDA, MDD, CSA & other Regulatory Agencies requirements.
Do you have a processes or equipment requiring Verification and Validation? This would include some of the following:
-Design and Development Validation
-Product Validation
-Software Validation
-Performance Evaluations
-Process Validation
-Equipment Validation
-Clinical Evaluations
Our quality consultant will assist you in implementing procedures and practices relating to:
Design, Installation, Operational, and Performance Qualification(DQ,IQ,OQ and PQ)
Verification is a quality control process that is used to evaluate whether or not a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production.
Validation is a quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.
Benefits
- Effective Validation Processes
- Guidelines for Regulatory Compliance
- Equipment and Software Validations for Regulatory Compliance.
Our quality consultant has 20+ years developing and managing various programs for FDA & MDD Compliance, CLIA, QSIT, CSA along with Commission and Validations for Pharmaceutical & Biotech manufacturing firms as well as FDA Class 2 & 3 Medical Device Manufacturers.
Our consultant is also an ISO 13485 Lead Auditor and experienced with compliance and regulatory requirements for FDA, MDD & CE Marking along with Validation.
He also works at a local A&E Firm that is a world industry leader in design, installation, commission and validation of Pharmaceutical & Biotech plants with major international offices located in San Juan, Puerto Rico, Ireland, Europe, China and Singapore that are key locations for Pharmaceutical & Biotech firms along with Medical Device manufacturing firms.