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.


Validation Plan Based on Risk Assessment

System Specifications to Define Intended Use & Create Acceptance Criteria

Create & Execute

Deliver Validation


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



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:



Medical Device Manufacturing


Contract Research Organizations


Clinical Trials

Food & Cold Chain Logistics


Systems Validated

Business Systems

System TypeVendors Validated
CSOSControlled Substance Ordering System
Data AnalysisMicrosoft R open source platform
Document ManagementDocuSign
Epicor ERP
Microsoft Dynamics 365
Oracle Netsuite ERP
Sage X3
Sage 100 ERP
Sage 200 ERP
Custom ERP
Inventory ManagementWebOps
Learning Management SystemComplianceWire
Test ManagementJama Connect

Clinical Trials

System TypeVendors Validated

Communication App
Ring Central
Clinical Study RandomizationPRemier IRT
Electronic Data CaptureIBM Clinical Development
Medidata Rave
Electronic Trial Master File (eTMF)Microsoft Teams used as an Electronic Trial Master

Facilities & Maintenance

System TypeVendors Validated
Building Automation System (BAS)Siemens Desigo
Rockwell BAS
Building Management System (BMS)Honeywell Enterprise Building Integrator
Trane Trane Tracer Ensemble
Dickson DicksonOne
Inventory ManagementAsset Panda
Temp MappingKaye
Calibration and Maintenance Management System (CMMS)IndySoft


System TypeVendors Validated
Chromatography Data System (CDS)Chromatography Data System (CDS)
Lab Data AnalysisStatistical Analysis
Lab Instrument/softwarePCR
Plate Reader


System TypeVendors Validated
Biological Specimen Management SystemBSI Systems
Imaging Inspection SystemKeyence Laser Microscope
Nikon Camera Software
Data HistorianOSI PI
Delta V
Track and TraceTraceREADY
Warehouse ManagementManhattan Scale


System TypeVendors Validated
Medical DatabaseEUDAMED/UDI
Drawing ManagementPLM
Aquant IO


System TypeVendors Validated
AuditInternal Systems
ConsultingInternal Systems
IT Infrastructure validationInternal Systems
Periodic Review System Development and ValidationInternal Systems
Custom Software ValidationInternal Systems
Validation System and Processes DevelopmentInternal Systems
Project Management ServicesInternal Systems

Recent Articles

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Identifying CSV Compliance Violations: Lessons Learned from an FDA Inspection in June 2023

During an FDA inspection in June 2023, several violations related to computer system / software compliance and general quality system processes were identified. Here is a link to the letter:  Warning Letter CMS #653455 The warning letter details a variety of violations that can be addressed through computer system validation (CSV), computer software assurance, equipment […]
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Staff Augmentation for CSV Services: A Cost-Effective Solution for Your Business  

Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
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Microsoft Dynamics 365 Computer Systems Validation

Case Study
At a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year.  CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]