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Computer system validation (CSV) is an essential practice in FDA-regulated industries that involves verifying and ensuring the integrity, reliability, and compliance of computer systems used in critical processes like pharmaceutical manufacturing, medical devices, and clinical trials. This comprehensive validation process encompasses the entire system lifecycle, including requirements definition, system design, configuration, testing, installation, operation, and maintenance. Partner with Performance Validation (PV) for effective CSV services that optimize system performance for maximum efficiency and dependability.
CSV Mitigates Risks in FDA-Regulated Industries
By adhering to regulatory guidelines and industry standards, computer system validation helps mitigate risks associated with system failures, data integrity issues, and security breaches. It ensures that these systems perform as intended, maintain data accuracy, and comply with regulatory requirements, thereby supporting the safety, efficacy, and quality of products and services in FDA-regulated industries.
Comprehensive CSV Services that Deliver Results
When you need CSV services that ensure regulatory compliance and industry standards, count on PV to get the job done. Leveraging our expertise and proven methodologies, we minimize timelines, cut costs, and mitigate risks. Trust us for reliable system performance, data accuracy, and regulatory adherence to bolster your product and service quality.
Validation Strategy Development
Create a plan to ensure your computer system meets regulatory requirements, industry standards, and business needs. This involves identifying key validation objectives, assessing risks associated with the system, defining the scope of validation activities, and determining the approach to validation.
System Risk Assessment
21 CFR Part 11 Assessment
Data Integrity Assessment
Supplier/Vendor Assessment
Specification Development
During specification development, we will create detailed documentation that outlines the functional and operational requirements of your system. These specifications define how the system should behave, including its inputs, outputs, processing logic, user interfaces, and security features. By clearly defining system specifications upfront, you can minimize misunderstandings, errors, and deviations during the validation process, ultimately leading to more efficient and effective validation outcomes.
User Requirement Specification
Functional Specification
Configuration Specification
Design Specification
Requirements Traceability Matrix
Testing Development and Execution
Rely on PV to create and implement protocols to verify your system operates as intended and meets regulatory requirements. This process includes designing test cases based on system specifications, regulatory standards, and user requirements. Test cases include various scenarios to assess functionality, performance, security, and data integrity. Execution involves running these test cases, recording results, and documenting any deviations or issues encountered.
IT Infrastructure Qualification
Installation Qualification (IQ) Specification
Operational Qualification (OQ)
Performance Qualification (PQ)
User Acceptance Testing (UAT)
Ad-hoc / Unscripted Testing
Regression Testing
Data Migration Testing
Onsite or Remote Test Execution
Validation Reporting
Our experts will compile and document the results of validation activities conducted throughout the validation lifecycle. This documentation proves that the system meets regulatory requirements, industry standards, and user needs. Validation reports typically include summaries of validation activities, test results, deviations encountered, and conclusions drawn from the validation process. These reports provide stakeholders, including regulatory agencies, with a comprehensive overview of the validation effort and demonstrate that the system is fit for its intended use.
IQ/OQ/PQ Testing Summary Reports
Validation Summary Reports, Final Report
Change Management
Change management ensures that any modifications to your system are assessed for their potential impact on system functionality, data integrity, and regulatory compliance. It involves procedures for evaluating proposed changes, determining the necessary validation activities, documenting change requests, obtaining approvals, implementing changes in a controlled manner, and updating validation documentation as needed. Effective change management helps maintain the integrity and compliance of validated computer systems over their lifecycle, ensuring that they continue to perform reliably and meet regulatory requirements.
Strategy/Procedural Development
Planning/Execution
AUDITING / CONSULTING
Auditing and consulting are crucial in helping you navigate complex validation requirements, mitigate risks, and ensure the integrity and reliability of computer systems within regulated industries. Our team will provide you with an independent assessment of your systems and offer guidance on validation strategies, methodologies, and documentation practices to enhance the effectiveness and efficiency of validation efforts.
CSA Training / Strategy
Computer System Compliance Auditing
Computer System Compliance Consultation
Data Integrity Assessment and Remediation
Periodic Review
Regulatory gap analysis and remediation (e.g., 21 CFR Part 11, cGMP, GLP, data integrity)
Supplier/Vendor Audits
Standard Operating Procedure Authoring/Consultation
Leveraging Vendor Documentation
PERFORMANCE VALIDATION’S CSV PROCESS:
Validation Plan Based on Risk Assessment
System Specifications to Define Intended Use & Create Acceptance Criteria
Create & Execute
Testing
Deliver Validation
Package
Continue
Support
Experts in Validating All Types of Computer Systems
PV boasts a proven track record of excellence in ensuring the reliability, compliance, and efficiency of diverse technological infrastructures. With our comprehensive expertise, we meticulously validate various computer systems:
- Enterprise Resource Planning Systems (ERP)
- Electronic Quality Management Systems (eQMS)
- Laboratory Information Management Systems (LIMS)
- Clinical Data Systems (EDC, eTMF)
- Calibration and Maintenance Management Systems (CMMS)
- Laboratory Instrument Software
- Environmental Monitoring Systems (EMS)
- Building Management and Automation Systems (BAS / BMS)
- Warehouse Management Systems (WMS)
- Labeling and Packaging Systems
- Automation Systems
PV’s CSV Team Supports the Following Sectors
Contract Research Organizations
Laboratory
Clinical Trials
Food & Cold Chain Logistics
Trust PV for Validated Systems You Can Rely On
With a proven track record of excellence, PV ensures that all systems undergo rigorous validation processes to meet regulatory requirements and industry standards. Our experienced team meticulously validates each system, ensuring its reliability, accuracy, and compliance.
Business Systems
| System Type | Vendors Validated |
|---|---|
| CRM | Salesforce |
| CSOS | Controlled Substance Ordering System |
| Data Analysis | Microsoft R open source platform |
| Document Management | DocuSign Falcon |
| ERP | Acumatica Epicor ERP Microsoft Dynamics 365 Oracle Netsuite ERP Sage X3 Sage 100 ERP Sage 200 ERP IQMS/DELMIAWorks Custom ERP |
| Inventory Management | WebOps |
| Learning Management System | ComplianceWire |
| Test Management | Jama Connect |
Clinical Trials
| System Type | Vendors Validated |
|---|---|
Communication App | Ring Central |
| Clinical Study Randomization | PRemier IRT |
| Electronic Data Capture | IBM Clinical Development Medidata Rave |
| Electronic Trial Master File (eTMF) | Microsoft Teams used as an Electronic Trial Master |
Facilities & Maintenance
| System Type | Vendors Validated |
|---|---|
| Building Automation System (BAS) | Siemens Desigo Rockwell BAS |
| Building Management System (BMS) | Honeywell Enterprise Building Integrator Trane Trane Tracer Ensemble Dickson DicksonOne |
| Inventory Management | Asset Panda |
| Temp Mapping | Kaye |
| Calibration and Maintenance Management System (CMMS) | IndySoft MircoMain Maximo |
Laboratory
| System Type | Vendors Validated |
|---|---|
| Chromatography Data System (CDS) | Chromatography Data System (CDS) |
| Lab Data Analysis | Statistical Analysis |
| Lab Instrument/software | PCR Plate Reader Ultrasound LIMS LIS |
Process
| System Type | Vendors Validated |
|---|---|
| Biological Specimen Management System | BSI Systems |
| Imaging Inspection System | Keyence Laser Microscope Nikon Camera Software |
| Labeling | LabelVision |
| LIMS | MODA |
| Packaging | Systech |
| Data Historian | OSI PI |
| SCADA | Ignition SCADA Delta V |
| Track and Trace | TraceREADY |
| Warehouse Management | Manhattan Scale |
Quality
| System Type | Vendors Validated |
|---|---|
| Medical Database | EUDAMED/UDI |
| Drawing Management | PLM |
| eQMS | QT9 MasterControl QISS eQms TrackWise Aquant IO |
Other
| System Type | Vendors Validated |
|---|---|
| Audit | Internal Systems |
| Consulting | Internal Systems |
| IT Infrastructure validation | Internal Systems |
| Periodic Review System Development and Validation | Internal Systems |
| Custom Software Validation | Internal Systems |
| Validation System and Processes Development | Internal Systems |
| Project Management Services | Internal Systems |
Streamlined CSV Compliance & Faster Time-to-Market
At PV, CSV is at the core of our services, reflecting our deep commitment to ensuring compliance and reliability for FDA-regulated industries. With the evolution of CSV practices and industry standards, our team has remained at the forefront, equipped with extensive expertise to navigate the complexities of CSV.
PV’s Innovative Validation Methods
We prioritize critical thinking and risk assessment, enabling us to optimize validation processes, deliver enhanced efficiencies, and offer cost savings for our clients. Our comprehensive approach covers a wide range of areas, including serialization, building management/automation, and electronic quality management systems (eQMS).
Accelerate Your Validation Journey with PV
One of the key advantages of partnering with us for CSV lies in the significant reduction in time associated with validation programs. By employing a risk-based approach, we identify and prioritize critical components, focusing our efforts on areas that truly matter while ensuring compliance with regulatory requirements. With our meticulous attention to detail and in-depth knowledge of FDA regulations, you can confidently navigate the validation process with ease. By entrusting us with your CSV needs, you can achieve faster time-to-market for products without compromising on quality or regulatory adherence.
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