JAF Consulting
JAF Consulting is a trusted strategic partner for Life Sciences companies, providing expertise in regulatory compliance, systems validation, auditing, and training. With over 20 years of industry experience, they help organizations meet and exceed quality standards, simplify compliance processes, and prepare for audits with a well-structured, sustainable framework. They also offer a comprehensive vendor alliance program with trusted partners across software, staffing, consulting, and systems integration, enabling end-to-end solutions for complex regulatory and operational challenges. The company is actively expanding its services, including upcoming offerings in validation program management, software selection, and training, as well as new resources for GxP, GCP, GLP, CSV, and REDCap services.
Industries
Nr. of Employees
small (1-50)
JAF Consulting
Clarksboro, New Jersey, United States, North America
Products
Auditing & Assessment Services (fact sheet)
Fact sheet describing auditing and assessment services for GxP compliance, including audit types, scope and remediation planning.
Part 11 / Electronic records compliance (fact sheet)
Fact sheet summarizing services related to electronic records, electronic signatures compliance and remediation for regulated systems.
Validation program management (fact sheet)
Fact sheet describing validation program governance, project management and execution support for multi-system validation programs.
QAaaS and Training (fact sheet)
Fact sheet outlining Quality Assurance as a Service offerings and training/education programs for regulatory and technical topics.
Software selection & implementation (fact sheet)
Fact sheet describing software selection, vendor assessment and implementation advisory services for regulated systems.
Auditing & Assessment Services (fact sheet)
Fact sheet describing auditing and assessment services for GxP compliance, including audit types, scope and remediation planning.
Part 11 / Electronic records compliance (fact sheet)
Fact sheet summarizing services related to electronic records, electronic signatures compliance and remediation for regulated systems.
Validation program management (fact sheet)
Fact sheet describing validation program governance, project management and execution support for multi-system validation programs.
QAaaS and Training (fact sheet)
Fact sheet outlining Quality Assurance as a Service offerings and training/education programs for regulatory and technical topics.
Software selection & implementation (fact sheet)
Fact sheet describing software selection, vendor assessment and implementation advisory services for regulated systems.
Services
Turnkey validation services covering validation master planning, URS workshops, IQ/OQ/PQ protocol development and execution, test scripting, remediation planning, periodic evaluation and decommissioning support.
GLP/GCP/GMP audits, mock inspections, site/vendor/study/TMF audits, gap analyses and remediation planning to prepare organizations for regulatory inspections.
Assessment and validation of EDC systems and electronic records/signatures including audit trail review, access control assessment, backup/restore and retention strategies, and PHI/HIPAA considerations.
Development and review of validation documentation, SOPs and user requirements; facilitated workshops to capture system and user needs and align documentation with regulatory expectations.
Customizable training programs and instructional design for GxP, computer systems validation, data integrity and related compliance topics delivered in-person, virtually or via eLearning and webinars.
Assistance with vendor assessment, product selection, SDLC guidance and implementation planning to align software choices with validation and regulatory requirements.
Turnkey validation services covering validation master planning, URS workshops, IQ/OQ/PQ protocol development and execution, test scripting, remediation planning, periodic evaluation and decommissioning support.
GLP/GCP/GMP audits, mock inspections, site/vendor/study/TMF audits, gap analyses and remediation planning to prepare organizations for regulatory inspections.
Assessment and validation of EDC systems and electronic records/signatures including audit trail review, access control assessment, backup/restore and retention strategies, and PHI/HIPAA considerations.
Development and review of validation documentation, SOPs and user requirements; facilitated workshops to capture system and user needs and align documentation with regulatory expectations.
Customizable training programs and instructional design for GxP, computer systems validation, data integrity and related compliance topics delivered in-person, virtually or via eLearning and webinars.
Assistance with vendor assessment, product selection, SDLC guidance and implementation planning to align software choices with validation and regulatory requirements.
Expertise Areas
- Computerized systems validation (CSV)
- Validation program governance and project management
- GxP auditing and inspection readiness
- Electronic records, electronic signatures and data integrity
Key Technologies
- Electronic data capture (EDC) platforms
- Laboratory information management systems (LIMS)
- Warehouse management / materials planning / ERP systems
- Manufacturing execution systems (MES) and electronic batch records (EBR)
News & Updates
Partner with @jafconsulting for all your compliance needs on YouTube.
Introduction video of JAF Consulting by Joe Franchetti.
Short advertisement video of JAF Consulting from 2022.
Insights on leveraging compliance for strategic advantage in private equity.
Guide on NFC tools app usage for contact info writing.
Tips on avoiding common GLP compliance mistakes.
Partner with @jafconsulting for all your compliance needs on YouTube.
Introduction video of JAF Consulting by Joe Franchetti.
Short advertisement video of JAF Consulting from 2022.
Insights on leveraging compliance for strategic advantage in private equity.
Guide on NFC tools app usage for contact info writing.
Tips on avoiding common GLP compliance mistakes.