- installation of the Atlas Client on each of the user PCs with IQ testing for this step and complete documentation
- setting up the individual user accounts
- production of the relevant standard operating procedures (SOPs)
- training of the users
- a URS
- acquisition documentation: quotation, capital justification and special purchase requisition
- product documentation as deemed necessary
- vendor release documentation
- a completed supplier assessment questionnaire
- a validation plan
- IQ documentation
- OQ documentation
- additional OQ test scripts
- a test plan (user acceptance plan)
- acceptance test logs
- a URS traceability matrix
- a validation summary report
- user manuals
- training material
Conclusion This article illustrates the procedures involved in the successful validation and implementation of a chromatography data system as a replacement for an old system. The project involved the use of SDLC principles and the processes were documented at each stage. Resources from various departments across the company were required and, along with the tight deadlines imposed, careful planning and teamwork were essential from the start to achieve a successful outcome.
The phased approach adopted for this validation meant that the system hardware could be fully qualified and the software validated for the functionalities required for the Pharmaceutical Analysis Department. In reality, these included the major components of the application and allowed for the departmental-specific functions to be validated in Phase 2. This phased approach also meant that the implementation into the first user department could be achieved on schedule and with minimum disruption to project timelines. This made the subsequent deployment into the rest of the site a shorter and more manageable project.
Acknowledgements The authors would like to thank the many users involved in the validation and implementation of the CDS and Thermo LabSystems' Pathfinder services group for the installation and operational qualification documentation. The authors would also like to thank Bob McDowall from R D McDowall Consultancy Services for QualifyPlus documentation, on which part of this project was based.
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