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Computer system validation 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. 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.
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
Streamlined CSV Compliance & Faster Time-to-Market
At Performance Validation, Computer System Validation (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.
We prioritize critical thinking and risk assessment, enabling us to optimize validation processes, deliver enhanced efficiencies, and 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).
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 for your CSV needs, you can achieve faster time-to-market for products without compromising on quality or regulatory adherence.
Our Experience
- 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
CSV Services
Validation Strategy Development
System Risk Assessment
21 CFR Part 11 Assessment
Data Integrity Assessment
Supplier/Vendor Assessment
Specification Development
User Requirement Specification
Functional Specification
Configuration Specification
Design Specification
Requirements Traceability Matrix
Testing Development and Execution
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
IQ/OQ/PQ Testing Summary Reports
Validation Summary Reports, Final Report
Change Management
Strategy/Procedural Development
Planning/Execution
AUDITING / CONSULTING
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
PV Serves the Following Areas:
Pharma
Manufacturing
Medical Device Manufacturing
Warehousing
Contract Research Organizations
Laboratory
Clinical Trials
Food & Cold Chain Logistics
SaMD
Systems Validated
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 |
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