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- EudraLex Annex 11 - German Version
- EMA news: Harmonised requirements for batch certification
- Annex 11 - “Computerised Systems” - Revision 2011 - Implementation
- CRO Computer System Validation: FDA Requirements
- ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
- Guidance for Industry - Process Validation: General Principles and Practices
- EudraLex - Volume 4 (GMP): New Annex 11 (revision January 2011)
- New EudraLex Vol. 4 - Annex 11 - Computerised Systems
- PIC/S EXPLANATORY NOTES FOR SITE MASTER FILE
- New GHTF document - CAPA
- New Audit Services provided to industry
- FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs
- Book of Validation - Download current regulations and templates
- Medical Devices QMS: ISO 13485 and FDA requirements
- Chinese ISPE GAMP 5 Version
- Germany's BfArM moves to nearly paperless submissions (eCTD)
- New GAMP publication: GAMP Good Practice Guide: MES
- New GAMP publication: GAMP Good Practice Guide: A Risk-Based Approach to Operation
- Computer Validation - FDA expectations and requirements
- ICH Q10 - Quality Systems guideline
- New: ISPE Good Practice Guide: Maintenance
- ICH Q8/Q9/Q10 - Questions & Answers
- ISPE Pharmaceutical Engineering Publication - March April 2009
- ISPE Good Practice Guide: Good Engineering Practice published
- ICH: Contact the Quality IWG with your comment and questions concerning Q8-Q9-Q10
- PIC/S: REVISION OF PIC/S GMP GUIDE
- EMEA: Eudralex Version 19 December 2008
- 21 CFR Part 11: current status (2008)
- GAMP 5 and PRODUCT QUALITY LIFECYCLE IMPLEMENTATION (PQLI)
- FDA Warning Letters 2008 (computer system validation)
- ICH Q10: PHARMACEUTICAL QUALITY SYSTEM - Step 4
- CMMI - Capability Maturity Model Integration (GAMP 5) for development
- Computer System Validation in the area of GCP
- ISPE NEW BASELINE® GUIDE: Risk-MAPP
- PFQ magazine: E-signature article published by IT Pharma Validation members
- EMEA: Public consultation on revisions of GMP Annex 11 on Computerized Systems
- FDA: 21 CFR Parts 210 and 211 ACTION: Direct final rule; withdrawal
- FDA Acronyms and Abbreviations Database
- GAMP 5 and ISO 12207
- ISO 12207 and GAMP 5 reference
- GAMP 5 Newsletter - Holistic approach to science-based risk management
- ASTM E2500 and GAMP5: A New Approach to Validation
- ASTM E2500 and GAMP5: A New Approach to Validation
- ISPE pulished the new GAMP 5 Guide
- EMEA - GMP Guidelines to implement concept of Quality Risk Management (ICH Q9 to Annex 20)
- PIC/S Guide: GMP for Healthcare establishments
- EMEA announces plans for electronic-only marketing submissions
- ICH Q10: Quality Management Systems
- US FDA 21 CFR Parts 210/211 Amendment to the Current Good Manufacturing Practice Regulations
- Special: QM Systems and CSV for API Production
- Recommendation on Electronic Signatures by the Association for Pharmaceutical Technology
- US FDA Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility
- Articles Listing
- EudraLex Annex 11 - German Version
- EMA news: Harmonised requirements for batch certification
- Annex 11 - “Computerised Systems” - Revision 2011 - Implementation
- CRO Computer System Validation: FDA Requirements
- ISPE published the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
- Guidance for Industry - Process Validation: General Principles and Practices
- EudraLex - Volume 4 (GMP): New Annex 11 (revision January 2011)
- New EudraLex Vol. 4 - Annex 11 - Computerised Systems
- PIC/S EXPLANATORY NOTES FOR SITE MASTER FILE
- New GHTF document - CAPA
- New Audit Services provided to industry
- FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs
- Medical Devices QMS: ISO 13485 and FDA requirements
- Chinese ISPE GAMP 5 Version
- Germany's BfArM moves to nearly paperless submissions (eCTD)
- New GAMP publication: GAMP Good Practice Guide: MES
- New GAMP publication: GAMP Good Practice Guide: A Risk-Based Approach to Operation
- Computer Validation - FDA expectations and requirements
- ICH Q10 - Quality Systems guideline
- New: ISPE Good Practice Guide: Maintenance
- ICH Q8/Q9/Q10 - Questions & Answers
- ISPE Pharmaceutical Engineering Publication - March April 2009
- ISPE Good Practice Guide: Good Engineering Practice published
- ICH: Contact the Quality IWG with your comment and questions concerning Q8-Q9-Q10
- PIC/S: REVISION OF PIC/S GMP GUIDE
- EMEA: Eudralex Version 19 December 2008
- 21 CFR Part 11: current status (2008)
- GAMP 5 and PRODUCT QUALITY LIFECYCLE IMPLEMENTATION (PQLI)
- FDA Warning Letters 2008 (computer system validation)
- ICH Q10: PHARMACEUTICAL QUALITY SYSTEM - Step 4
- CMMI - Capability Maturity Model Integration (GAMP 5) for development
- Computer System Validation in the area of GCP
- ISPE NEW BASELINE® GUIDE: Risk-MAPP
- PFQ magazine: E-signature article published by IT Pharma Validation members
- EMEA: Public consultation on revisions of GMP Annex 11 on Computerized Systems
- FDA: 21 CFR Parts 210 and 211 ACTION: Direct final rule; withdrawal
- FDA Acronyms and Abbreviations Database
- GAMP 5 and ISO 12207
- ISO 12207 and GAMP 5 reference
- GAMP 5 Newsletter - Holistic approach to science-based risk management
- ASTM E2500 and GAMP5: A New Approach to Validation
- ASTM E2500 and GAMP5: A New Approach to Validation
- ISPE pulished the new GAMP 5 Guide
- EMEA - GMP Guidelines to implement concept of Quality Risk Management (ICH Q9 to Annex 20)
- PIC/S Guide: GMP for Healthcare establishments
- EMEA announces plans for electronic-only marketing submissions
- ICH Q10: Quality Management Systems
- US FDA 21 CFR Parts 210/211 Amendment to the Current Good Manufacturing Practice Regulations
- Special: QM Systems and CSV for API Production
- Recommendation on Electronic Signatures by the Association for Pharmaceutical Technology
- US FDA Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility
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