A useful guidance, edited under the umbrella of EANM Radiopharmacy Committee, for the use, installation, cleaning, and validation of automated systems has been recently published (Aerts et al. 2014), and general principles of cleaning validation may be found.
The phases used and analyzed based on Waterfall model are the Requirements specification, Design, Construction (implementation or coding), Integration, Testing and debugging (validation), Installation and Maintenance (Table 2).
This paper describes the design and implementation of the QD system, Installation experience, validation test and initial results from the recent SST-1 magnet system charging.
These tasks cover operations and maintenance procedures; overall validation; and installation and commissioning.
Methods: In addition to non-pharmacological validation including installation and operation qualifications, performance qualification (locomotor activity and cardiovascular evaluations) was completed on free-moving cynomolgus monkeys by quantifying the degree of cardiovascular response measured by the telemetric device to various positive control drugs following their intravenous administration.
Topics discussed include selecting a security system; selecting a vendor or supplier; system installation; the turn-on period; system testing, evaluation, and validation; and system policies and procedures.
A large repository of legacy archetypes from several vendors and installations could potentially be used as an inspiration and validation when creating a library of "standard" archetypes on regional and national level, which is currently taking place in Sweden.
The challenge is not simply a matter of cost relating to the equipment purchase, but also the fact that the installation of new equipment will necessitate a lengthy programme of qualification and validation work.
Starting in mid-2007, the project is managed by the two Home Teams (JA-HT and EU-HT) and headed by the Project Team at the Broader Approach site in Rokkasho with the aim to complete the validation activity with the installation and commissioning of the whole LIPAc by June 2017.
It was reassurance and validation.
