Director & FDA Compliance Specialist,
Computer System Validation and FDA Compliance consultant
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.
David Nettleton is also the co-author of:
- Managing the Documentation Maze - Answers to Questions You Didn't Even Know to Ask (Wiley - www.wiley.com) 2010
- Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com, 2004)
- Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org, 2003).