CSV, Data Integrity & Process Validation
Compare vendors for csv, data integrity & process validation within Quality, GxP & Validation, covering Computer System Validation & CSA, Data Integrity & 21 CFR Part 11 Compliance, Equipment, Process & Cleaning Validation, Validation Lifecycle Management Platforms.
Capabilities in this workflow
Vendors supporting this workflow
Service Provider · +2 more types
Products: D.AI.M.I.
“Computerised Systems Validation in all GxP areas (Management Systems, Production Control Systems and Laboratory Applications)”Source: plglifesciences.com
Also offers: Equipment, Process & Cleaning Validation, Regulatory Development Strategy & Agency Interactions, +5 more
Consulting / Advisory Firm · +2 more types
“…Throughout the validation process, our engineers will also ensure that all associated QMS documentation is available in order to maintain compliance.”Source: rookqs.com
Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs, +1 more
Consulting / Advisory Firm · +1 more type
Products: Cell Therapy Orchestration Platform (CTOP), Life Sciences Accelerator for S/4HANA
“A Computer System Validation (CSV) / Computer System Assurance (CSA) Managed Services partner can provide relief to your internal team by helping to prepare key validation…”Source: clarkstonconsulting.com
Also offers: Quality Management System (QMS) Consulting, Transformation, Integration & Change Management, +2 more
Software / Technology Platform · +2 more types
Products: Vault CRM, Veeva RIM +6 more
“It streamlines commissioning, qualification, and validation activities across computerized systems, facilities, utilities, equipment, and processes.”Source: veeva.com
Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more
Consulting / Advisory Firm · +2 more types
“Providing comprehensive validation services for GxP compliance”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more
Consulting / Advisory Firm · +1 more type
“cGMP/ cGLP, cGCP Assessments including general cGMP inspection readiness, PAI readiness, facility and equipment design, PART 11 compliance as well as data integrity assessments…”Source: tunnellconsulting.com
Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +2 more
Software / Technology Platform · +2 more types
“Apply statistical analysis to audit trail data across large study datasets to identify patterns of data manipulation, anomalous entry behavior, and digit preference that manual…”Source: cluepoints.com
Also offers: Risk-Based & Centralized Trial Monitoring, Clinical Data Management
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Computer system validation for all GxP-relevant systems”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
CRO / Research Services Provider · +3 more types
Products: Acceleration Platform
“Part 11 compliance assessments”Source: altasciences.com
Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“Computer System Validation (CSV) and Computer Software Assurance (CSA)”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more