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Validation Services
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Synteract provides full and incremental validation services for Clinical and Safety Data Management Systems. Our extensive product knowledge, industry experience and understanding of regulatory requirements enable us to provide superior validation consulting services.
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Validation Overview
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Validation establishes documented evidence providing a high degree of assurance that a specific computerized process or operation will consistently produce a quality result meeting its predetermined specifications. The most important goal is to document that a system consistently does what it is intended to do. Synteract provides full validation services including:
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- Validation Project Management
- Validation Requirements Consulting
- Test Script Development
- Test Script Execution
- GAP Analysis
- SOP development
- SOP review
- Post Validation Implementation Services
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The Validation Process
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Synteract provides full and incremental validation services for Clinical and Safety Data Management Systems. Our extensive product knowledge, industry experience and understanding of regulatory requirements enable us to provide superior validation consulting services.
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| Validation Plan
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The Validation Plan contains the definition, scope, roles, responsibilities, and description of each deliverable.
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| Functional Requirements
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Includes the system description, the purpose of the system, the user requirements and a prioritized table of users "must have" and "want to have" items.
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| System Design
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Includes security and system specifications. This document describes how the system functionality satisfies the users' functional requirements. It also addresses Functional Requirements that cannot be met and why.
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| Traceability Matrix
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Lists each functional requirement and shows that it was addressed either by being included in the system or indicating why not.
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| Installation Qualification (IQ)
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Documentation to verify that all key aspects of the installation adheres to the appropriate design intentions and specifications. The documentation contains instructions for installing and verifying the installation of the hardware and software.
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| Operational Qualification (OQ)
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Documentation and testing to demonstrate that the system components perform as intended throughout all anticipated operating ranges.
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| Performance Qualification (PQ)
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(User Acceptance Testing)- Document and verify that the process and total related system components perform as intended throughout all anticipated operation ranges. Typically this document would include: response times, system capacity, and user acceptance tests.
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| Summary Reports
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Result of the testing and what will be done to address any shortcomings.
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| Other Documents in a Validated System
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Change Management
Vendor Requirements
Design Documents
Training Class Descriptions and Sign-off
User Manuals
SOPs
Security
Operational Support
Contingency Plan
Record Retention
Periodic Review
System Maintenance
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The Vendor Audit
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The purpose of the Vendor Audit is to determine the vendor's outlook and philosophy on quality, documentation, and compliance to FDA standards and industry guidelines. In addition, the audit helps establish that the vendor has used an organized methodology to build a verifiable, validatable system and that such a system can be supported throughout its economic lifetime. The vendor audit frequently includes a site visit.
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SOPs and SWPs
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Standard Operating Procedures (SOPs) and Standard Working Procedures (SWPs) pertinent to the use of the computerized system should be available on site. According to the FDA's Guidance for Industry: Computer Systems Used in Clinical Trials, SOPs should be established for, but not limited to:
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- System Setup/Installation
- Data Collection and Handling
- System Maintenance
- Data Backup, Recovery, and Contingency Plans
- Security
- Change Control
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