Eolus has extensive experience helping our clients to understand and comply with Electronic Records & Electronic Signatures regulations. Our consultants stay abreast with the latest FDA guidance for Data Integrity. Our services range in scope from Audits, Training, Risk Assessments, Software Evaluations, Project Planning & Management, to Software Validation projects to ensure compliance of software applications, systems and infrastructure. We provide end to end data integrity assessments and reviews.
Standards and References
- FDA Glossary of Computerized System and Software Development Terminology
- General Principles of Software Validation; Final Guidance for Industry, FDA
- Data Integrity and Compliance, FDA
- GAMP 5, A Risk-Based Approach to Compliant GXP Computerized Systems, 2nd Edition
- Good Documentation Practices (GDP)
- GAMP Data Integrity Guide
- International Conference on Harmonization (ICH) E6, Good Clinical Practices (GCPs)
- Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guidance for Computerized Systems
- 21 CFR 11, Electronic Records; Electronic Signatures
- 21 CFR 312, Investigational New Drug Application
- 21 CFR 50, Protection of Human Subjects
- 21 CFR 54 Financial Disclosure by Clinical Investigators
- 21 CFR 56 Institutional Review Boards (IRB)
- 21 CFR 211 Current Good Manufacturing Process (cGMP)
- 21 CFR 820, Quality System Regulation (QSR)
- 21 CFR Part 58, Good Laboratory Practices (GLP)
- ISO 27001: Information Security Management System (ISMS)
- ISO 27701: Information Security, Cybersecurity, Privacy
- ISO 13485: Quality Management System (QMS)
- ISO 14971: Medical Devices, Application of Risk Management
- ICH Q9 (R1) Pharmaceutical Risk Management
- ICH Q10 Pharmaceutical Quality System
- ICH E6 (R3), Good Clinical Practices (GCP)
- IEC 62304 Medical Device Software, Software Lifecycle
- EU Good Data Privacy Regulation (GDPR)
- EU GMP Annex 11, Computerized Systems
- PICs/GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS
- EMA Guideline on Computerized systems and electronic data in clinical trials
- Medicine & Healthcare Products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions
Key Industry Association Presentations
- DIA Conference on EDC-October 1999: “Electronic Data Capture;a Lotus on Onion Blossom?”
- Fraser Williams Users Group Meeting – May 2000: “To Validate or not to Validate, That is the Question”
- Barnett & PDA/FDA conference – June 2000: “Electronic Records: Real Life Scenarios”
- PDA Annual Meeting – Dec 2000: A Project Management Approach to Compliance Programs”
- DIA Annual Meeting – July 2001: “IVR Case Study for Success”
Patents
US Patent serial number 10/132,537 (Weldon et al) filed April 25, 2002, related to systems, methods and computer program products for designing, deploying and managing interactive voice response (IVR) systems for Clinical Research – April, 2002
Key Publications
- “Electronic Records: An “IVR Cast Study for Success”. Quality Assurance Journal, volume 6, issues 2 – June 2002, Wiley & Sons, LTD.
- “Good Practice and Compliance for Electronic Records and Signatures (Part 1) Good Electronic Records Management (GERM)“, CoAuthor and PDA Task Force member, 2002
- “Good Practice and Compliance for Electronic Records and Signatures (Part 2) Complying with 21 CFR Part 11, Electronic Records and Signatures“, GAMP Forum, PDA Task Force, 2001
- “Good Practice and Compliance for Electronic Records and Signatures (Part 3) Models for Systems Implementation and Evolution“, CoAuthor and PDA Task Force member, 2004
- “Current Concepts in Validation and Compliance, Computerized Systems Used in Non Clinical Safety Assessment”; GLP, DIA RED Apple II Committee Member, Collaborator and Co-Author. 2007
- “System and Data Integrity for Clinical Trials”; GCP, DIA Peach Committee member and Co-Author, 2008
- Good Clinical Practice, A Question and Answer Guide, Section 10, FDA inspections, Quality Assurance Activities, and Study Auditing, 2020 CoEditor with Earl Hulihan, Section 10
Current and Previous Professional Associations
- ASQ, American Society of Quality
- CDISC, Clinical Data Interchange Standards Consortium
- DIA, Drug Information Association
- PDA, Parental Drug Association
- Medical Device Engineers and Consultants
- NCCSQA; NC Society of Quality Associates
- TTEC, Triangle Technology Executive Committee
- ANSI RAB Accredited ISO9001 Lead Auditor
- PDA/ARC Computer Supplier Auditor Certificate #1064
- Triangle PEERS: Electronic Records/Data Integrity