SERVICES | VALIDATION & QUALIFICATION
Comprehensive Solutions Tailored to Your Regulatory and Quality Needs
SERVICES
VALIDATION & QUALIFICATION
Validation Master Plant
- Site Validation Master Plan preparation to outline and define the validation philosophy, practices, Schedule, scope, resources, requirements, etc.
Risk Assessment for Validation Projects.
- Preparation of Risk Assessment for Validation Projects to support the Site Validation Master Plan, to ensure its well implementation and conclusion.
Validation and Qualification Protocols Preparation.
- Protocols preparation compliance with regulatory requirements, as be required for each validation Project including but no litimted to Analytical Method Validation, Equipment Qualification, Computerized System Validation, Process Validation, etc.
URS & FRS preparation.
- User Requirement and Functional Requirement Specification preparation documents in compliance with regulatory requirements applicable and customer’s company requirements.
Validation/Qualification Projects Management
(Equipment, Cleaning, Process, Analytical Methods,
Critical Systems, Computerized Systems, etc.)
- Support on the plan definition for Validation Master Plan implementation and execution considering the limitations, exceptions and compliance requirements.
Validation & Qualification Documentation Framework
- Creation of Validation & Qualification critical documentation framework, which could include but not limited to: SOP, Protocols template, Risk Assessment template, Validation Inventory Template, etc.