Search

Showing total 3 results
Start Over Search Limiters Peer Reviewed Publisher mjh life sciences
3 results

1. How Complete Are Your Chromatographic Data? Part 2.

Author

McDowall, R. D.

Subjects
*PAPER, *ELECTRONIC records, *INFORMATION retrieval, *QUALITY control, *LABORATORIES, *CHROMATOGRAPHIC analysis
Abstract

The article looks at paper versus electronic records in the context of complete data under the U.S. Food and Drug Administration's (FDA) Good Manufacturing Practice (GMP) regulations for quality control (QC) laboratories in the U.S. It considers whether complete data includes the electronic files generated from a chromatographic analysis or just the signed paper printouts. The requirements for complete data for laboratories working under the FDA GMP regulations are highlighted.

Published
2013

2. The Fully Electronic Office (or Clinical Trial) Myth.

Author

Blelcher, Paul

Subjects
*CLINICAL trials, *OFFICE practice automation, *PAPER, *RECORDS management, *ELECTRONIC records, *ELECTRONIC office machines, *TECHNOLOGICAL innovations
Abstract

Comments on the efforts to shift from automation and online data processing technology in clinical trials and office practice in lieu of using paper. Development and innovation of electronic office machine equipments; Accessibility of data and information through electronic document management; Plight of the paperless clinical trails.

Published
2004

3. New GMP Initiatives Published.

Subjects
PUBLISHING, WEBSITES, PAPER, ARCHIVES, PHARMACEUTICAL industry
Abstract

The article reports that the EU Commission and EMEA have published several documents for consultation on their website. These documents revise some existing GMP requirements and also add some new ones. Titles of these papers include Concept Paper Dealing With the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products; Inspections at Manufacturers of Active substances; Public Consultation: Authorizations for Manufacturing and Import and GMP Certificates etc.

Published
2005