Document Library
Showing 113–128 of 179 results
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SOP Software Vendor Assessment
Outlines the quality assurance approach to audits and assessments of software suppliers. SOP is intended to be used with the Software Vendor Assessment template.
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SOP System Backup
Defines the controls needed to back up the software and data for use in system restoration or recovery. Includes backup schedules, content, review, and verification.
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SOP System Restore
This SOP defines the procedures and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster.
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SOP System Risk Assessment
Assess and analyze the quality risk for systems used in regulated activities. Includes risk assessment timing, procedures, criticality, classification, and documentation.
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SOP System Risk Management
Overall program of procedures and controls for managing quality risks for systems used in regulated activities. Includes definitions, responsibilities, and approach.
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SOP System Risk-Based Validation
Procedure for defining a validation approach based on the risk assessment and vendor audit. Includes details on the impact to validation testing and documentation.
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SOP System Security
Defines the controls needed to secure the systems, records, and data used in regulated business. Includes physical security, configuration protection, passwords, and more.
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Eudralex V4 Chapter 4: Documentation, 1/11
This version of Volume 4, Chapter 4, Documentation, was published in January 2011 to correspond with changes in EU GMP Annex 11, Computerised Systems.ﾠ
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Eudralex V4 Annex 11: Computerised Systems, 1/11
This version of Annex 11, Computerised Systems, was published by the EC in January 2011 to address the increased use and complexity of computerised systems.
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SOP User Training
Defines the procedures and controls to ensure that employees have the training needed to perform assigned responsibilities regarding systems used in regulated activities.
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Japan Q&A on GMP Guideline on Managment of Computerized Systems, 10/10
An independent group produced this translation of the Q&A document that accompanies the 2010 Japaneseﾠ Guideline on Management of Computerized Systems.
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Japan GMP Guideline on Management of Computerized Systems, 10/10
English translation of the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Drug Manufacturers.
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Chinese Good Manufacturing Practices for Drugs, 10/10
The 2010 revision of Good Manufacturing Practices for Drugs from the Chinese Ministry of Health went into effect on March 01, 2011.
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EMA Reflection Paper on Expectations for Electronic Source Data & Data Transcribed to Data Collection Tools in Clinical Trials, 8/10
This reflection paper outlines GCP inspectors’ expectations for computer system topics such as validation, SOPs, audit trails, backups, security, user training, and record archival.
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Q&A on cGMP Good Guidance Practices – Records and Reports
In this publication from www.FDA.gov, the FDA answers the question: How do the Part 11 regulations and “predicate rule requirements” in 21 CFR 211 apply to chromatograms
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FDA Guidance: Inspection of Clinical Investigators, 6/10
Published in June, 2010 to provide information about FDA inspections of clinical investigators conducted under FDA’s Bioresearch Monitoring (BIMO) Program.
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