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21 CFR Part 11: Complete Guide to International Computer...

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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

López, Orlando

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Որքա՞ն է ձեզ դուր եկել այս գիրքը:

Ինչպիսի՞ն է բեռնված ֆայլի որակը:

Բեռնեք գիրքը` գնահատելու դրա որակը

Ինչպիսի՞ն է բեռնված ֆայլերի որակը:

Կատեգորիաներ:

Տարի:

2004

Հրատարակչություն:

CRC Press

Լեզու:

english

Էջեր:

243

ISBN 10:

084932243X

ISBN 13:

9780849322433

Ֆայլ:

PDF, 2.69 MB

IPFS:

,

english, 2004

Կարդալ Առցանց

Փոխարկումը դեպի կատարվում է

Փոխարկումը դեպի ձախողվել է

Ձեզ կարող է հետաքրքրել

Tuan T.Phan — Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11

Food and Drug Administration (Author) — Compact Regs Part 11: CFR 21 Part 11 Electronic Records: Electronic Signatures (10 Pack)

David Nettleton Janet Gough — Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Orlando Lopez — 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Wingate, Guy — Pharmaceutical computer systems validation : quality assurance, risk management and regulatory compliance

Orlando Lopez — EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Ispe Headquarters — GAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems

Ispe Headquarters — GAMP RDI Good Practice Guide: Data Integrity by Design

Schoonmaker, Stephen J. — ISO 9001 for Engineers and Designers 1997

Yusufali F. Musaji — Integrated Auditing of ERP Systems

ISPE — ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)

IT Compliance Institute (ITCi) [ed.] — Information Security

Medina C. (ed.) — Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

— OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE

Food and Drug Administration — Compact regs part 11 : code of federal regulations 21 : part 11 : electronic records : electronic signatures

Leonard Steinborn — GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers

— Computer Systems Validation

John Andrews (Editor) — Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Simon G Turner — Pharmaceutical engineering change control

Richard C. Fries (Editor) — Handbook of Medical Device Design

Roberts (Author) — Quality Assurance in Research and Development

Joseph F. deSpautz (Author) — Automation and Validation of Information in Pharmaceutical Processing

Richard C. Fries (Author) — Handbook of Medical Device Design

Janet Gough, David Nettleton — Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask

Siri H. Segalstad — International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

Siri H. Segalstad — International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries

David Groth, Jarret W. Buse, David Groth et al — A+ Complete Study Guide

Allen Keele, Keith Mortier — The CISA Prep Guide: Mastering the Certified Information Systems Auditor Exam

Richard C. Fries — Handbook of Medical Device Design

Sandy Weinberg — Good Laboratory Practice Regulations

Carmen Medina — Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Leonard Steinborn (Author) — GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines): Regulations, Standards, and Guidelines

Guy Wingate — Computer systems validation: quality assurance, risk management and regulatory compliance for pharmaceutical and healthcare companies

John Andrews — Validating pharmaceutical systems: good computer practice in life science manufacturing

Sandy Weinberg — Laboratory Practice Regulations

R D McDowall; — Validation of chromatography data systems : meeting business and regulatory requirements

Donald C. Singer — A Laboratory Quality Handbook of Best Practices & Relevant Regulations

Mark Allen Durivage [ed.] — The Certified Pharmaceutical GMP Professional Handbook

Davani, Behnam — Pharmaceutical analysis for small molecules

Behnam Davani — Pharmaceutical Analysis for Small Molecules

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