Skip to main content
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
ASSESS & PLAN
REQUIREMENTS
DESIGN & BUILD
TEST DEPLOY
CONTINUE SUPPORTOptimal 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
Contract Research Organizations
Laboratory
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 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 |
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
