Data Integrity & 21 CFR Part 11 Compliance Vendors
Services or software that assess, remediate, or monitor data integrity in a client's regulated records: electronic records and signatures, audit trail review, ALCOA+, and 21 CFR Part 11 or Annex 11 compliance.
Related workflows
Consulting / Advisory Firm · +2 more types
Halloran Consulting Group is a life-sciences consulting firm providing regulatory strategy, dossier writing, GxP quality, and clinical trial management.
Evidence-backed capability match
“Our consultants excel in data integrity across domains, crafting strategies to provide consistent integrity and inspection readiness.”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more
Consulting / Advisory Firm · +1 more type
Tunnell Consulting is a life sciences consulting firm providing GxP compliance, regulatory strategy, and technology transfer support.
Evidence-backed capability match
“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
Consulting / Advisory Firm · +1 more type
Clarkston Consulting is a life-sciences consulting firm providing quality compliance, digital and AI strategy, and transformation services.
Products: Cell Therapy Orchestration Platform (CTOP), Life Sciences Accelerator for S/4HANA
Evidence-backed capability match
“We have helped global life sciences companies establish scalable data integrity programs that ensure compliance across multiple regulatory bodies and drive demonstrative…”Source: clarkstonconsulting.com
Also offers: Quality Management System (QMS) Consulting, Transformation, Integration & Change Management, +2 more
Software / Technology Platform · +2 more types
CluePoints provides clinical trial oversight software and consulting for risk detection, data quality, monitoring, coding, and inspection readiness.
Evidence-backed capability match
“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
Service Provider · +2 more types
ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.
Products: D.AI.M.I.
Evidence-backed capability match
“Data integrity programs: policies, training, and system controls”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
CRO / Research Services Provider · +3 more types
Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.
Products: Acceleration Platform
Evidence-backed capability match
“Part 11 compliance assessments”Source: altasciences.com
Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more
Compare listed vendors
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Altasciences | CRO / Research Services Provider | — | “Part 11 compliance assessments”altasciences.com · reviewed Oct 21, 2026 |
| Clarkston Consulting | Consulting / Advisory Firm | Computer System Validation & CSA | “We have helped global life sciences companies establish scalable data integrity programs that ensure compliance across multiple regulatory bodies and drive…”clarkstonconsulting.com · reviewed Oct 21, 2026 |
| CluePoints | Software / Technology Platform | — | “Apply statistical analysis to audit trail data across large study datasets to identify patterns of data manipulation, anomalous entry behavior, and digit…”cluepoints.com · reviewed Oct 24, 2026 |
| Halloran Consulting Group | Consulting / Advisory Firm | Computer System Validation & CSA | “Our consultants excel in data integrity across domains, crafting strategies to provide consistent integrity and inspection readiness.”hallorancg.com · reviewed Oct 21, 2026 |
| ProductLife Group | Service Provider | Computer System Validation & CSA, Equipment, Process & Cleaning Validation | “Data integrity programs: policies, training, and system controls”plglifesciences.com · reviewed Oct 26, 2026 |
| Tunnell Consulting | Consulting / Advisory Firm | Equipment, Process & Cleaning Validation | “cGMP/ cGLP, cGCP Assessments including general cGMP inspection readiness, PAI readiness, facility and equipment design, PART 11 compliance as well as data…”tunnellconsulting.com · reviewed Oct 21, 2026 |