Computer Systems Validation
Interphase Systems can help you validate your Manufacturing, Automation and Controls Systems. This type of Validation requires an in-depth technical knowledge of the systems along with validation expertise. Our consultants have the experience and skills needed to validate these complex systems.
Interphase Systems also provides validation expertise in the areas such as laboratory operations (R&D, QA/QC), and clinical development. From bench-top to LIMS, our services include equipment qualification and laboratory computer system validation, among others. We offer a risk-based approach to compliance.
The following are several of Interphase Systems offerings in Computer Systems Validation.
| Service Offering |
Examples |
| Interphase Systems offers a risk-based approach to compliance life cycle validation services for computer systems.
We have experience with computerized systems used in Manufacturing Systems, Enterprise Systems, Laboratory Systems and Quality Systems (IT) among others. We can validate systems prospectively or retrospectively for commercial off-the-shelf (COTS) software, configurable COTS software, or custom designed software.
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Manufacturing
- Manufacturing Floor equipment, PLCs, SCADA (Supervisory Control and Data Acquisition), DCS (Distributed Control System), BAS (Building Automation System), and HVAC Systems
Enterprise Systems
- Customer Relationship Management (CRM) Application
- Sales Force Automation (SFA) Application
- ERP Implementations
Laboratory
- Laboratory operations (R&D, QA/QC) and clinical development. From bench-top to LIMS, including equipment qualification and laboratory computer system validation, among others
IT Systems
- CAPA, PRISM, Records Management, Configuration Control
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System Development Life Cycle
Interphase Systems has a Life Cycle Methodology that breaks the development into eight phases. The content of these phases would be altered to fit your company’s quality requirements.
The following table describes the Validation deliverables associated with each phase.
| Phase |
Phase Description |
Phase Deliverables |
| Phase I: Project Initiation Phase |
Establish a project team and select a vendor for the system. |
- Gap Analysis
- Vendor Assessment Report
- Risk Analysis/Assessment
|
| Phase II: Planning Phase |
Define the validation strategy, roles and responsibilities, and deliverables that will be developed and generated as evidence of the validation. |
- Project Validation Plan (PVP)
|
| Phase III: Requirements Phase |
Define user and functional requirements for the system, from a user, functional, and technical perspective. |
- User Requirement Specification (URS)
- Functional Requirement Specification (FRS)
|
| Phase IV: Design Phase |
Define the system design from a technical and infrastructure perspective. |
- System Design Specification (SDS)
|
| Phase V: Development / Configuration Phase |
Define the configuration of the system, from a business, technical, and infrastructure perspective. |
- Configuration Specification
|
| Phase VI: Qualification / Test Phase |
Develop and execute the qualification test scripts in the Validation/Test Environment to challenge the requirements defined in the FRS and URS documents. |
- Qualification Plan
- Installation Qualification (IQ) Test Scripts
- Operational Qualification (OQ) Test Scripts
- Performance Qualification (PQ) Test Scripts
- Requirements Traceability Matrix
|
| Phase VII: Implementation Phase |
Notify the Project Team that the system meets the requirements defined in the URS and FRS documents and has been deemed appropriate for installation in the Production Environment. |
- Validation Summary Report (VSR)
|
| Phase VIII: Operational / Maintenance Phase |
Define the procedures, rules, and instructions for the use, administration, and maintenance of the system and notify the users that the system has been successfully validated and has been deemed appropriate for release/use in the Production Environment. |
- Operational SOPs
- Work Instructions / Process Guidelines
- System Manuals
- Training Records
- System Release Certificate
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