Validation of Spectrometry Software

Here are all articles from my column called Focus on Quality from Spectroscopy magazine dealing with the validation of spectrometry software. This is a series that has been published since 2002 and each article covers specific areas of computer validation.

• Validation Of Spectrometry Software 1
  Covering the general principles of software validation and the definition of key terms used in the subject.
• Validation Of Spectrometry Software 2
  Roles of the Validation Plan and User Requirements Specification, the defining documents of a software validation project are presented and discussed.
• Validation Of Spectrometry Software 3
  Vendor Audit, System Purchase and Preparation for Installation are covered in this article.
• Validation Of Spectrometry Software 4
  Qualification of the Software and System looks at the Installation Qualification and Operational Qualification stages of a validation.
• Validation Of Spectrometry Software 5
  An overview of the Performance Qualification phase of validation is discussed in this article.
• Validation Of Spectrometry Software 6
  Ways of designing Performance Qualification tests is discussed in this article including how much is necessary when writing test scripts.
• Validation Of Spectrometry Software 7
  Covered in this article are the topics of training, system documentation and writing the validation summary report to complete the initial validation.
• Validation Of Spectrometry Software 8
  No system remains in its initial configuration for long and once operational the most difficult part of computer validation starts - maintaining the validation. Hence the need for effective change control and configuration management.
• Validation Of Spectrometry Software 9
  Protecting electronic records created by any system is important from both business and regulatory perspectives, this paper looks at backup and recovery and the various options available.
• Validation Of Spectrometry Software 10
  Documentation of backup and recovery is as important as doing the backup itself, hence this article looks at the documentation involved in the process.