Articles by Orlando Lòpez - Pharmaceutical Technology

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Articles by Orlando Lòpez

Orlando Lòpez

senior consultant

Orlando LLòpez is a senior consultant in the coputer systems validation department at McNeil Consumer & Specialty Pharmaceuticals, 7050 Camp Hill Rd., Fort Washington, PA 19034, tel. 215.273.7903.

Articles
Annex 11: Progress in EU Computer Systems Guidelines
June 1, 2011

In January 2011, a new version of Annex 11 was released by the European Commission along with a revision of Chapter 4 of its GMP on documentation to reflect the actualities of electronic record keeping, all of which come into full effect in June 2011.

Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II
March 1, 2002

Current security technologies and associated infrastructures are designed to protect information assets and satisfy 21 CFR Part 11 requirements for integrity and privacy of records using authentication and encryption methods.

Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part I
February 1, 2002

A combination of security technologies, infrastructures, and cryptographic product-services families can help companies satisfy the requirements of 21 CFR Part 11.

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