Regulations and Guidelines
Showing 65–80 of 133 results
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Japan MHLW Ordinance 28 Good Clinical Practice for Drugs, 12/12
Japan’s Ministerial Ordinance provides GCP standards to ensure the quality of clinical trials and the reliability of clinical trial data for drugs.
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FDA 21 CFR 211: Docket FDA-1997-N-0518, 3/12
This docket changed 21 CFR 211 to allow use of automated techniques to physically prevent incorrect labeling from being processed when cut labeling is used.
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EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples, 2/12
The European Medicines Agency (EMA) published this guidance. It was adopted by the Good Clinical Practices (GSP) Inspectors Working group on February 28, 2012.
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EC Proposed General Data Protection Regulation, 1/12
In January, 2012 the EC proposed this regulation. This regulation will impact several areas, including adverse event reporting and clinical trial data management.
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EC Medical Device Guidance: Qualification and Classification of Stand Alone Software, 1/12
In January 2012, the EC published this guidance to define the criteria for the qualification of stand alone software, when used in a healthcare setting as a medical device.
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FDA Guidance: Current Good Tissue Practice (GGTP) and Additional Requirements, 12/11
The US FDA published this Guidance for Industry to provide guidance on compliance with 21 CFR Part 1271, Current Good Tissue Practice.
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WHO Specifications for Pharmaceutical Preparations, 6/11
This WHO Expert Committee Report was published in 2011. Usage and controls for computerized systems are described throughout the documents.
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FDA 21 CFR 880: Docket FDA-2008-N-0106, 4/11
This FDA docket went into effect on April 18, 2011. With this change, the FDA exempted MDDSs from pre-market notification requirements.
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FDA Guidance: Computer Crossmatch, 4/11
This April 2011 FDA guidance aims to assist blood establishments performing compatibility testing using a computer crossmatch system in cGMP compliance.
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EMA Annex 11 Computerised Systems FAQ Q&A, 2/11
The EMA published answers to frequently asked Annex 11 questions. The EC’s new version of Annex 11, Computerised Systems, went into effect on June 30, 2011.ﾠ
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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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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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