Computer Software Assurance (CSA) is crucial in the life science industry, where software systems (hardware, software, processes) play a vital role in data creation, management, product production, and regulatory compliance. It helps to safeguard data, optimize system performance, and mitigate potential threats, ensuring the highest standards of quality and reliability in software development and implementation. By implementing CSA measures, you can minimize the risk of software errors, enhance operational efficiency, and maintain compliance with industry regulations. Partner with the CSA experts at Performance Validation (PV) to keep your software systems compliant for present and future needs.

Advancements in CSA Guidance

In recognition of the growing importance of Computer Software Assurance (CSA) in the life science industry, the Food and Drug Administration (FDA) released comprehensive guidance on CSA in September 2022. This guidance provides organizations with valuable recommendations and best practices for implementing risk-based CSA measures to ensure the security, availability, and reliability of computer systems and software used in GxP-regulated activities, marking a significant milestone in advancing software assurance practices in the industry. All PV engineers are up-to-date with the latest CSA guidance to ensure your software systems remain optimized and compliant.

Service Any Life Science Software System Efficiently

No matter what kind of software systems you use, rely on our experienced team to service them with precision:

  • 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

Performance Validation’s CSA Process

Regulatory Requirements & Industry Best Practices
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Project Management (Budget, Time, People)

Optimal CSA Services Start with PV

Leave all your CSA service needs to the experienced team at PV. Our engineers guarantee the reliability, security and compliance of your software systems, enabling seamless operations and regulatory adherence.

Improve Software Quality

Rely on us to identify and eliminate defects, vulnerabilities, and other issues that affect the quality and reliability of your software applications. Through thorough testing and adherence to regulatory requirements and industry best practices, we ensure that your software performs reliably, giving you confidence in its performance.

Enhance Software Security

Our commitment involves pinpointing and resolving defects, vulnerabilities, and other potential issues that may compromise the quality and dependability of software applications. Through comprehensive testing and adherence to regulatory standards and industry norms, we provide you with the assurance you need in their software’s performance and reliability.

Reduce Time to Qualify & Validate

Our approach to CSA includes leveraging vendor documentation, which helps expedite the qualification and validation process. By utilizing comprehensive vendor documentation, we can efficiently assess and verify the compliance of software systems, resulting in reduced time and effort required for qualification and validation. This streamlined approach increases client satisfaction by delivering timely and reliable solutions while maintaining regulatory compliance.

PV’s CSA Team Supports the Following Sectors


Medical Device Manufacturing


Contract Research Organizations


Clinical Trials

Food & Cold Chain Logistics

Explore the Systems We Validate

PV has experience validating all types of software systems for various vendors. When you need dependable CSA service, count on our team to deliver results.

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

Pioneers in CSA Services Since 2019

At PV, we have incorporated CSA concepts into our services, recognizing their value to the industry. CSA started surfacing around 2019 through various channels such as training, webinars, and articles. It quickly became evident that the FDA was embracing a leaner approach to Computer System Validation (CSV), and we immediately understood its potential benefits.

Streamline Validation & Save Money with PV

We focus on critical thinking and risk assessment, allowing us to streamline our validation processes and deliver greater efficiencies and cost savings to our clients. Implementing CSA principles spans various areas, including serialization, building management/automation, and electronic quality management systems. By adopting a risk-based approach, we can identify and prioritize the critical components of these systems, optimizing our efforts and resources.

Tailored Validation Strategies that Reduce Time & Ensure Compliance

One of the key advantages of CSA is the significant reduction in time and cost associated with CSV programs. Instead of following a rigid, one-size-fits-all approach, CSA enables us to tailor our validation strategies to the specific needs and risks of each client. This flexibility allows us to focus our efforts on the most critical aspects, ensuring compliance while minimizing unnecessary validation activities. As a result, you can achieve faster time-to-market for your products while maintaining the highest quality and regulatory standards.

Guarantee Software System Security & Reliability

Our SMEs are well-equipped to determine the appropriate utilization of either CSA or CSV for a given project. By carefully assessing project requirements, industry regulations, and risk profiles, our team ensures that the most suitable approach – be it CSA or CSV – is employed to guarantee the security, reliability, and compliance of software systems.

Your Dependable Partner for Compliant Software Systems

Your life science software systems are too important to let just anyone service them. Trust in our vast experience to keep your systems operating at optimal levels while maintaining compliance with regulatory requirements.

Recent Articles

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Enhancing Efficiency and Effectiveness: The Positive Impact of CSA on CSV Programs 

In the pharmaceutical industry, computerized systems (hardware, software, processes) play a critical role in creating and managing data, producing products, and ensuring compliance with regulatory requirements. 21 CFR Parts 210 and 211 contain aspects which drive the need for computer system validation (CSV). Of course, there is 21 CFR Part 11 (electronic records and signatures) […]
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Streamlining Medical Device Validation: A Risk-Based Approach to Computer Software Assurance

Computerized systems (hardware, software, and processes) play a critical role in the medical device industry. They are used to create and manage data, produce products, and ensure compliance with regulatory requirements.  Computer system validation (CSV) is the process of ensuring that computerized systems meet their intended requirements and can consistently produce accurate and reliable results. […]
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Systech Serialization Project for Large Pharmaceutical Manufacturer

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