Update on ISPE GAMP Guides

The International Society of Pharmaceutical Engineering publishes the Good Automated Practices Guides including GAMP from 2008 which coverscomputer system validation in general and a number of more recent guides on topics ranging from mobile apps to IT infrastructure control. The current list of available guides is:

  • GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • A Risk-Based Approach to Calibration Management (Second Edition)
  • A Risk-Based Approach to Electronic Records and Signatures
  • A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • A Risk-Based Approach to GxP Process Control Systems (Second Edition)
  • A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion – Volume to GAMP® 5
  • A Risk-Based Approach to Regulated Mobile Applications
  • A Risk-Based Approach to Testing of GxP Systems (Second Edition)
  • Electronic Data Archiving
  • Global Information Systems Control and Compliance
  • IT Infrastructure Control and Compliance
  • Legacy Systems
  • Manufacturing Execution Systems – A Strategic and Program Management Approach
  • Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement
  • Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System

Use of these guides is not required or officially recognized by FDA and their use does not ensure compliant validation, risk analysis conformant with international standards, or the most efficient validation techniques. If used, SoftwareCPR suggests they be used as educational material with knowledgable critical thinking applied and tailored to your specific situation. For medical device companies, FDA staff collaborated with AAMI to produce an AAMI standard/TIR36 Validation of Software for Regulated Processes. This is avaiable at AAMI.org.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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