Document Library
Showing 33–48 of 179 results
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EMA E6(R2): Guideline for Good Clinical Practice, 7/15
July, 2015 consensus draft of ICH E6(R2) for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
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ICH E6(R2): Good Clinical Practice, 6/15
June, 2015, ICH consensus draft for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
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PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15
Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.
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Eudralex V4 Annex 15: GMP Guidelines for Qualification and Validation, 3/15
EudraLex Volume 4, Annex 15 now refers users to Annex 11, Computerised Systems, for the specific details regarding validation of computer systems.
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EC Guidelines on Good Distribution Practice for Active Substances, 3/15
In March, 2015 the EU Commission published GDP Guidelines for APIs. Details for electronic records, systems, and signatures are found throughout.
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FDA Presentation: Mobile Medical Apps, MDDS, General Wellness Apps, 2/15
FDA presentation to clarify guidance documents for Mobile Medical Applications, General Wellness Applications, and Medical Device Data Systems.
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FDA Guidance: Mobile Medical Apps, 2/15
This February 2015 FDA guidance provides information about how the agency intends to apply its regulatory authority to software applications on mobile platforms.
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FDA Guidance: Medical Device Data Systems, Image Storage Devices, and Image Communications Devices, 2/15
In February, 2015, the FDA published this guidance to inform that they does not intend to enforce compliance with the regulatory controls for Medical Device Data Systems.
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EMA Classification and Analysis of the GCP Inspection Findings 2000-2012
In December, 2014, the EMA (European Medicines Agency) published this analysis for the 398 EMA GCP (Good Clinical Practice) inspections conducted in the years 2000-2012.
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FDA Guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood Components, 12/14
This December 2014 US FDA guidance provides manufacturers of licensed blood and blood components with recommendations on submission of BLA changes.
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FDA Guidance: Design Considerations for Devices Intended for Home Use, 11/14
November 2014 FDA guidance on designing and developing home use devices that comply with safety standards, effectiveness standards, and regulatory requirements.
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FDA Guidance: Contents of Premarket Submissions for Management of Cybersecurity in Medical Devices, 10/14
In October, 2014 the FDA published this guidance to the cybersecurity issues that manufacturers should consider in the design and development of their medical devices.
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OECD The Application of GLP Principles to Computerised Systems DRAFT, 9/14
2014 draft OECD publication of standards for laboratory computer systems used in clinical studies destined for regulatory submissions.
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FDA Guidance: FDA Decisions for Investigational Device Exemption Clinical Investigations, 8/14
2014 FDA recommendations to industry, investigators, IRBs, and FDA staff to promote the initiation of clinical investigations to evaluate new medical devices
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PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products, 6/14
In June, 2014, this PIC/S Guide went into effect to ensure high standards of quality assurance and integrity for distribution of medicinal product.
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MHRA Guidance: Medical Device Stand-Alone Software (Including Apps), 3/14
March 2014 MHRA guidance on medical device stand-alone software, including apps, for people working in healthcare and companies developing devices.
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