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Industrial Automation
Validation Services
Instrumentation Services
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Data Integrity
Outsourcing Services
Manufacturing Execution Systems (MES)
Industries
BioPharma
Medical Devices
Water Wastewater
Power & Energy
Food & Beverage
Platforms
Rockwell Automation
Emerson DeltaV
Foxboro I/A
General Electric iFix
Siemens
OSIsoft
TiPS LogMate
Wonderware
Werum PAS-X
Careers
About Us
Who is PACIV
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Corporate Social Responsibility
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Blog
Newsletters
Press Articles
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Privacy Policy
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FDA Regulations and Guidance Documents
FDA Part 22 – CGMP for Finished Pharmaceuticals, Subpart D–Equipment Sec. 211.68 Automatic, mechanical, and electronic equipment
Guide to Inspection of Computerized Systems in Drug Processing, Reference Material and Training Aids for Investigators, February 1983
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
Pharmaceutical CGMP’s for the 21st Century: A Risk Based Approach, August 2002
Final Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application, August 2003
ICH – Guidance For Industry – Q9 Quality Risk Management, June 2006
Industry Guidance Documents Links
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records and Signatures
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems
Baseline Guide Volume 5: Commissioning and Qualification
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Related Industry Links
Control System Integrators Association (CSIA)
International Society of Automation (ISA)
International Society of Pharmaceutical Engineering (ISPE)
Pharmaceutical Industry Association of Puerto Rico (PIA)
College of Engineers and Surveyors of Puerto Rico (CIAPR)
National Minority Supplier Development Council (NMSDC)
Puerto Rico Minority Supplier Development Council (PRMSDC
Mid-States (Indiana) Minority Supplier Development Council (MSMSDC)