Orlando López's 21 CFR 11: Complete Guide to International Computer PDF

By Orlando López

ISBN-10: 084932243X

ISBN-13: 9780849322433

This advisor delineates the association, making plans, verification, and documentation actions and procedural controls required for compliance with FDA rules with regards to overseas laptop validation within the pharmaceutical undefined. The advisor indicates the right way to agree to desktops validation specifications, whereas highlighting and integrating half eleven standards into the whole desktop validation application. Regulatory compliance is positioned in the context of caliber coverage, and the significance of integrating validation into the approach lifestyles cycle utilizing a established top-down technique is under pressure. info is acceptable to computers for prescribed drugs, cosmetics, nutrition, and scientific gadget purposes.

Show description

Read or Download 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry PDF

Similar pharmacy books

Drug Targeting Technology: Physical, Chemical and Biological - download pdf or read online

Discusses actual, chemical, and organic ways to drug concentrating on expertise, targeting oral, dispersed method, topical, dermal, transdermal, and inhalation supply, and the advance of unique formulations matched by means of cutting edge machine layout. For researchers.

Read e-book online Pharmaceutical Innovation: Incentives, Competition, and PDF

The pharmaceutical around the globe is a speedily burgeoning contributing to development of gross family product and employment. Technological swap during this box has been very fast, with many new items being brought. for that reason partly, overall healthiness care budgets in the course of the international have elevated dramatically, eliciting turning out to be pressures for price containment.

Read e-book online Good Pharmaceutical Freeze-Drying Practice PDF

This article is dedicated to pharmaceutical freeze-drying in all its types and in all its technological diversifications. no matter if you freeze-dry nonsterile pills otherwise you lyophilize injectables, this e-book covers all of the technological and regulatory standards. Written by means of a panel of top practitioners within the pharmaceutical -- construction specialists, regulatory inspectors, technical specialists, and gear providers -- the data is appropriate, usable, and well timed.

Download PDF by William J. Brock, Kenneth L. Hastings, Kathy M. McGown: Nonclinical safety assessment : a guide to international

Bringing a brand new drug to marketplace is a high priced time-consuming method. elevated nearby and foreign law over the past 20 years, whereas worthy, has in simple terms served to magnify those expenses. based on this escalation, developmental innovations have shifted in the direction of a extra international technique. to be able to create the main cost-efficient and secure techniques, it's serious for these bringing medicinal drugs to marketplace to appreciate either the globally permitted rules and the neighborhood adaptations.

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

Example text

Audit mechanism b. Metadata c. Display and reporting 5. Electronic signatures a. E-sign without biometric/behavioral identification b. E-sign with biometric/ behavioral identification c. Signature manifestation d. Signature purpose e. Signature binding 6. 4,5 3 In hybrid systems, some portions of a record are paper and some electronic. López, O, Automated Process Control Systems Verification and Validation, Pharmaceutical Technology, September 1997. 5 López, O, Implementing Software Applications Compliant with 21 CFR Part 11, Pharmaceutical Technology, March 2000.

12, ‘Vendor Responsibility’ and Part 11 has now established the detailed requirements for such records. In 1983, the FDA provided another important guideline applicable to computer hardware and software performing functions covered by the regulations. Their ‘Guide to Inspection of Computerized Systems in Drug Processing’ addresses the applicability of the regulations to computer systems. According to this guideline, computer systems hardware and software are considered equipment and records, respectively, within the context of the regulations.

In order to manage the execution and supervision of computer systems validation activities, there needs to be an organizational structure established. This chapter suggests an organizational structure for supporting to a computer validation program. ORGANIZATIONAL MODEL This model (Figure 6–1) is an example of how computer systems validation and its related activities can be organized and responsibilities allocated. Each organization should prepare a document to identify the roles and responsibilities appropriate for its business environment.

Download PDF sample

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

by Anthony

Rated 4.40 of 5 – based on 50 votes