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:

Regulatory Requirements & Industry Best Practices
ASSESS & PLAN
REQUIREMENTS
DESIGN & BUILD
TEST DEPLOY
word balloon icons CONTINUE SUPPORT
Project Management (Budget, Time, People)

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

icon

Medical Device Manufacturing

Warehousing

Contract Research Organizations

Laboratory

Clinical Trials

Food & Cold Chain Logistics

SaMD

Systems Validated

Business Systems

System TypeVendors Validated
CRMSalesforce
CSOSControlled Substance Ordering System
Data AnalysisMicrosoft R open source platform
Document ManagementDocuSign
Falcon
ERPAcumatica
Epicor ERP
Microsoft Dynamics 365
Oracle Netsuite ERP
Sage X3
Sage 100 ERP
Sage 200 ERP
IQMS/DELMIAWorks
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
MircoMain
Maximo

Laboratory

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

Process

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

Quality

System TypeVendors Validated
Medical DatabaseEUDAMED/UDI
Drawing ManagementPLM
eQMSQT9
MasterControl
QISS eQms
TrackWise
Aquant IO

Other

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

decorative icon

FDA’s Computer Software Assurance Guidelines 

Blog
In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]
decorative icon

Staff Augmentation for CSV Services: A Cost-Effective Solution for Your Business  

Blog
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 […]
decorative icon

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 […]