Industries Served
Industries Served
Embedded Files
Expertise Across Multiple Sectors
Expertise Across Multiple Sectors
Health and Life Sciences: Regulatory compliance and system assurance/validation using GAMP methodologies.
Technology: Vendor management and cybersecurity frameworks.
Manufacturing: ERP and QMS implementations and auditing.
Financial Services: Governance for SOX and GDPR compliance and IT auditing.
Frameworks & Regulatory Compliance
Frameworks & Regulatory Compliance
Regulatory Compliance
Regulatory Compliance
FDA 21 CFR Part(s) 11, 50, 54, 56, 58, 210, 211, & 820
SOX (Sarbanes-Oxley)
GDPR (General Data Protection Regulation)
IT Governance and Security
IT Governance and Security
COBIT 2019
NIST 800-53, 171, 61, CSF
ISO/IEC 27001, 27002, 27701
ISO/IEC 42001
SOC 2
FedRAMP
Process Optimization & Data Integrity
Process Optimization & Data Integrity
ISPE Data Integrity Maturity Model
CMMI Data Management Maturity Model
APQC Process Framework
Process Mapping
Process Optimization
Validation & Quality Systems
Validation & Quality Systems
CSV (Computer System Validation)
CSA (Computer Software Assurance)
GAMP (Good Automated Manufacturing Practice)
Policies & Procedures
Policies & Procedures
Quality Management-related Policies & Procedures
Document Control
Training
Change Control
Risk Management
CAPA
Supplier & Vendor Management
Validation-related Protocols & Test Procedures
Validation Master Plan
Computer System Validation/Assurance
Test Plan
IQ, OQ, and PQ
IT Policies & Procedures
Incident, Problem, Change, Release Management
SDLC Procedure
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