EU Annex 11 The European Union’s (EU) Annex 11 defines the EU’s regulations for using computerized systems in Good Manufacturing Practice (GMP) for life sciences products. Annex 11 is a checklist that enables European regulatory agencies to establish the requirements for automated systems related...
Learn about the updates to EU Annex 11 and how MasterControl can help achieve compliance with EU Annex 11 computerised software systems.
January 2011 saw the publication of the new revision of European Union (EU) GMP Annex 11 on computerized systems and Chapter 4 on documentation. What will the impact be of these two revised regulations on computerized spectrometry system... RD Mcdowall - 《Spectroscopy》 被引量: 0发表: 2011...
While there are many similarities between Annex 11 and Part 11, the two documents are also quite different. They’re both guidance forgood manufacturing practices (GMP)for the quality and compliance of computerized data systems for the manufacture of pharmaceuticals and medical devices. ...
Section 11. Periodic evaluation of the new 2011 Annex 11 clearly counters that misconception with the statement, "Computerized systems should be periodically evaluated to confirm that they remain in a valid state and are compliant with GMP." It goes on to say that the evaluation should include,...
Computer system and computerized method for partitioning data for parallel processing A computer system splits a data space to partition data between processors or processes. The data space may be split into sub-regions which need not be orthogonal to the axes defined by the data space's ...