Regulations and Guidelines
Showing 97–112 of 133 results
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EC Council Directives related to Medical Devices, 10/07
The cumulative directives of the European Parliament and Council from June 1993 through November 2007 regarding medical devices.
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EC Council Directives related to Active Implantable Medical Devices, 10/07
The cumulative directives of the European Parliament and Council from June 1990 through October 2007 regarding active implantable medical devices.
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PIC/S PI 011-3 PIC/S Guidance: Good Practices for Computerised Systems in Regulated “GXP” Environments, 9/07
PIC/S Guidance for validation, testing, life cycle, change control, electronic signatures, security, back-ups, and inspection of GxP computerized systems.
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PIC/S PE 005-3 GMP Guide for Blood Establishments, 9/07
September 2007 guidance for blood establishment inspections, including recommendations on system validation, security, backups, training, and change control.
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PIC/S PI 023-2 Aide-Memoire: Inspection of Pharmaceutical Quality Control Laboratories, 9/07
This PIC/S memory aid provides guidance to QC lab inspectors. It instructs inspectors to check LIMS validation, change control, training, access authorization, and security.
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FDA Guidance: Computerized Systems Used in Clinical Investigations, 5/07
This May, 2007 FDA guidance incorporates a risk-based approach to Part 11 and recommendations on system SOPs, security, audit trails, and developer training.
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FDA Investigations Operation Manual 2007; Chapter 5.3, 2/07
This guidance document on inspections provides FDA inspectors with instructions on collecting evidence, including electronic records.
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FDA CDER Compliance Initiatives, 6/06
June, 2006 presentation by Joseph Formulare with content on FDA’s application of a risk based models, quality by design, ICH Q10, and ICH Q7A.
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FDA Guidance: Q9 Quality Risk Management, 6/06
June, 2006 FDA issuance of the ICH Q9 quality risk management document. Annex shows how to apply risk based approach to computer validation.
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FDA Guidance: Using Electronic Means to Distribute Certain Product Information, 3/06
March, 2006 guidance on using e-mail, fax, and text messages to report product recalls.
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ICH Q9: Quality Risk Management, 11/05
November, 2005 ICH guideline for applying risk management processes. See Annex II section 4, for suggestions on applications for computer systems.
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FDA Guidance: Contents of Premarket Submissions for Software Contained in Medical Devices, 5/05
May, 2005 CDRH guidance with sections on software risk management, change control, software of unknown pedigree (SOUP), virus protection, interfaces, and networks.
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FDA Guidance: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, 1/05
This January 2005, FDA guidance is in Q&A format and has info on responsibilities, validation, and software security patches for networked medical devices.
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Japan MHLW Ordinance 179 2004 Manufacturing Control and Quality Control for Drugs, 12/04
This Ministerial Ordinance was published in 2004, and has requirements records and data throughout the document.
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Japan MHLW Ordinance 169 2004 Manufacturing Control and Quality Control for Medical Devices, 12/04
Japan’s Ministerial Ordinance for Manufacturing Control and Quality Control Standards for medical devices and in-vitro diagnostic reagents was published in 2004.
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FDA 69 CFR 71561: Establishment and Maintenance of Records, 12/04
FDA regulation from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Contains references to 21 CFR Part 11.
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