Meditech Validation Products & Services
Medtech Validation Product & Services
Medtech Validation Product & Services, to help medical device manufacturers and other life sciences customers navigate the complicated system validation process; covering typical regulatory requirements for quality systems, for exmaple:
• ISO 13485 / 9001 / 14971
• FDA CFR 21 Part 820
• FDA CFR 21 Part 11
Expandable offers three strategic options for satisfying the validation mandate of the FDA and other global quality system regulators.
1. Validation Toolkit for customer in-house validation
2. Professional turn-key services
3. Custom combination of Toolkit scripts and professional services
With the option of choosing among three practical approaches, Expandable customers can complete their validation project using the method that aligns best with their level of experience, strategic goals and capital resources.
All Expandable validation resources come with decades of experience helping life sciences manufacturers operate successfully in a highly regulated industry.
Meditech Validation Toolkit
For customers with the confidence to perform their own validation, Expandable provides a Validation Toolkit that includes the scripts and templates required to assure that the system and related business processes comply with the FDA and other regulatory agencies.
Developed for Expandable by life sciences industry professionals, the Toolkit templates include the necessary scripts that assist key personnel in completing the quality system validation requirements:
• Validation Plan (VP)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• User Functional Requirements (UFRS)
• Separate Risk Analysis (SRA)
• Trace Matrix (TRACE)
The validation protocol scripts clearly define and document each step required to validate the Expandable base system, encompassing critical components of the following quality areas:
• Inventory Control
• Job Scheduling/Costing
• Lot Tracking
• Master Scheduling
• Multiple Location
• Product Data Control
• Sales Order
• Utilities (Password Upload, User Field Names)