Regulations and Guidelines
The Validation Center library lets you access the software compliance regulations and guidance documents you need for the US, Europe, and many other countries in one place.
You can download the documents here for free, rather than hunting for them on the often difficult to navigate web sites of regulatory agencies and standards bodies.
Showing 1–16 of 133 results
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FDA Guidance: Data Integrity and Compliance with Drug CGMP, 12/18
This FDA Guidance outlines the agency’s expectations for data integrity controls such as, records and metadata retention, audit trail reviews, backups, access, unique logins, and record storage location.
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PIC/S PI 041-1 Draft Guidance: Good Practices for Data Management and Integrity, 11/18
November 2018, Draft PIC/S data management and integrity guidelines for manufacturers and distributors of APIs and medicinal products.
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FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations, 7/18
July 2018 FDA Guidance on the best practices to follow when using electronic health record (EHR) data in clinical investigations.
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MHRA GXP Data Integrity Guidance and Definitions, 3/18
This update to the MHRA Data Integrity Guidelines adds new topics, such as Cloud providers, electronic signatures, and data migrations.
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FDA Draft Guidance: Current Good Manufacturing Practice for Medical Gases, 6/17
June 2017 Draft FDA Guidance intended to assist manufacturers of medical gases in complying with the regulations within 21 CFR Parts 210 and 211.
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FDA Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations under Part 11 – Q&A, 6/17
June 2017 Draft FDA Guidance intended to assist study sponsors, investigators, IRBs, and CROs in complying with 21 CFR Part 11, Electronic Records; Electronic Signatures.
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Introduction), 1/17
Introduction to the January, 2017 version of the PIC/S GMP (good manufacturing practices) Guide. Explains the organization of Parts I and II and the Annexes
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part I), 1/17
In January, 2017 this PIC/S GMP guide went into effect. It includes expectations for documentation and expectations for validation.
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part II), 1/17
This January, 2017 PIC/S GMP guide contains recommendations for computerized systems, electronic documents, validation, and change control.
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Annexes), 1/17
In January, 2017, this PIC/S GMP Guide went into effect. The annexes provide additional information applicable to both finished medicinal products and active substances (APIs).
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FDA Guidance: Postmarket Management of Cybersecurity in Medical Devices, 12/16
This 2016 FDA Guidance is intended to the medical device industry of agency recommendations for managing postmarket cybersecurity vulnerabilities.
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FDA Guidance: Use of Electronic Informed Consent Questions and Answers, 12/16
This December 2016 guidance provides information regarding implementation of FDA-compliant electronic Informed Consent technologies and processes.
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FDA Presentation: General Wellness Guidance: Policy for Low Risk Devices, 9/16
September 2016 FDA CDRH presentation to provide clarity and examples of low risk medical devices for general wellness.
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Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 9/16
2016 FDA adoption of the 2000 ICH GMP Guide for Active Pharmaceutical Ingredient (API) Manufacturers. Topics include system validation, audit trails, security, back-ups.
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EMA Data Integrity for GMP and GDP Q&A, 8/16
August, 2106, EMA publication answering 23 questions related to Data Integrity. Includes data risk assessment, security, data review, and supplier controls.
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FDA Guidance: General Wellness: Policy for Low Risk Devices, 7/16
This July 2016 FDA Guidance is intended to provide clarity on the compliance polity for low risk products that promote a healthy lifestyle.
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