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. By implementing CSA measures, organizations can minimize the risk of software errors, enhance operational efficiency, and maintain compliance with industry regulations. It plays a vital role in safeguarding data, optimizing system performance, and mitigating potential threats, ensuring the highest standards of quality and reliability in software development and implementation.
In recognition of the growing importance of Computer Software Assurance (CSA) in the life science industry, the FDA (Food and Drug Administration) 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.

PERFORMANCE VALIDATION’S CSA PROCESS:
Why Partner with PV
At Performance Validation, we have incorporated CSA concepts into our services, recognizing the value it brings to the industry. CSA started surfacing around 2019 through various channels such as trainings, 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.
At 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. The implementation of CSA principles spans across a wide range of 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.
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, our clients can achieve faster time-to-market for their products, while maintaining the highest quality and regulatory standards.
By leveraginig our expertise, our SMEs are well-equipped to determine the approapriate 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.
HOW CLIENTS CAN BENEFIT FROM PV’S CSA SERVICES
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
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 |