Our Process

With regulatory compliance at the core of any CSV project, PV specializes in efficiently and effectively meeting regulatory requirements and industry standards – including 21 CFR Part 11 (Part 11), 21 CFR Part 820 Quality System Regulation, cGMPs, GLPs, and GCPs for computerized system compliance. Our team of experts can adhere to our client’s processes and procedures, or we can bring our own proven methodologies to provide our clients with secure and accurate data.

PERFORMANCE VALIDATION’S CSV PROCESS:

Validation plan based on Risk Assessment

System specifications to define intended use & create acceptance criteria

Create & Execute
testing

Deliver validation package

Continue
support

Innovation

As technology advances in the life science industry, PV is committed to being up to date on technologies, processes, industry guidelines, and best practices to deliver the most innovative approach to validation. We study and review market trends to be able to support our clients and provide them with the excellent service they have been known to expect.

Software as a Medical Device

Software as a Medical Device (SaMD) in the healthcare industry has come a long way in recent years. Properly validating software is a critical component of ensuring compliance, patient safety, and product quality. At PV, we pride ourselves in bringing clients peace of mind with efficient, timely, and high-quality project work that meets medical device regulatory requirements and streamlines business operations. We give proper attention to the validation process throughout the many stages of the lifecycle, ensuring the client has the proper documentation to validate the device according to FDA regulations.

As the digital health sector continues to grow and expand across many new devices, patient safety must remain a top priority for medical device companies. That is why clients can trust our team of experts to continue to stay ahead of industry standards and requirements to validate medical device software correctly and completely.

CSV Services

PV helps our clients meet FDA compliance for a wide range of computer system applications used at any point in the research, clinical testing, manufacturing, distribution, or storage processes.

Our CSV Services Include:

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

Planning/Execution

AUDITING / CONSULTING


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

Systems Validated

Business Systems

System TypeVendors Validated
CRMSalesforce
CSOSControlled Substance Ordering System
Data AnalysisMicrosoft R open source platform
Document ManagementDocuSign
Falcon
ERPAcumatica
Epicor ERP multiple including Medical
Microsoft Dynamics 365
Oracle Netsuite ERP
Sage X3
Sage 100 ERP
Sage 200 ERP and CRM for medium sized business
IQMS/DELMIAWorks
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
Packaging Systech
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