Each laboratory / organization can freely choose how many modules should be introduced and implemented. This depends on the size of the laboratory, the main topic, what tools and infrastructure are already available and which quality objectives are to be pursued.

The modules are self-contained areas and thus independent of any specific sequence. It is therefore freely choosable with what module to start. Here it depends on which area is most important for the respective laboratory / organization.

The modules do not follow any hierarchy, but represent minimum requirements to systematically improve quality in preclinical research. Therefore, all modules are important. They provide a flexible framework that covers all areas required for a comprehensive quality-oriented approach.

This is recommended for the following conditions:

• from a laboratory size of 20 employees
• with the aim of ensuring standards for methods, procedures and workflows
• to establish an open and transparent mindset in the laboratory with regard to error culture, handling of research data and publication of results
• to ensure continuous improvement and further development of laboratory processes and the quality of results
• to introduce a concept for practicable and effective quality assurance in preclinical research

No additional personnel is required for the introduction and implementation of PREMIER. It is important that the leadership and upper management stand behind the concept and take responsibility at all times. Furthermore, it is advantageous if one person (researcher, QM personnel or others) in the laboratory / organization takes care of the implementation of the processes and discusses the next steps with the management. The PREMIER team offers support at all times during the introduction and implementation.

Your first steps are:

• Click on the individual modules of PREMIER and find out about the contents of the quality blocks.
• Think about which contents are currently most important for your laboratory / organization.
• Contact the PREMIER team for an assessment to determine the status quo in your laboratory / organization.

The assessment conducted by the PREMIER team determines the status quo of the laboratory / organization with regard to existing infrastructure and quality assurance. The assessment determines which quality objectives the laboratory / organization is pursuing and which PREMIER modules are recommended in this respect.

The PREMIER team offers the assessment generally free of charge. Assessments can be conducted online or on site. On-site assessments are suitable for larger laboratories / organizations that require a more extensive site visit. In this case the PREMIER team would charge the travel expenses.

For smaller laboratories an assessment will take about 2-3 hours, for larger ones about 4-6 hours (possibly a day).

Quality assurance in preclinical research is an ongoing process that should be continuously improved and further developed. Implemented quality assurance tools should not simply be removed again unless it is proven that their implementation has not led to the desired results. The laboratory / organization should regularly check whether the introduced modules are accepted, applied and established by the researchers and whether a further extension of the topics as recommended in PREMIER is reasonable. The PREMIER team is happy to help and advise you on this at any time. Do not hesitate to contact us.

The PREMIER Wiki is linked at various places on the PREMIER website. You can find the link to the Demo Wiki under the Toolbox tab, PREMIER (under the clickable QM House) and the communication module (internal communication). The access data to the Demo Wiki are:

https://demo.premier-qms.org
Login: Demo
Passwort: premier123456

The template for the PREMIER Wiki platform is managed centrally for laboratories at Charité and MDC by the QUEST Center (BIH-Charité) via a Charité server, so that no separate virtual servers are required for the individual laboratories. If you would like to implement the Wiki in your lab, please contact the following address: natascha.drude@bih-charite.de

For all labs / organizations outside the Charité, PREMIER provides a corresponding access with user description. The wiki should be installed on a server by the IT department of your organization/institute. To get access to the PREMIER Wiki, please contact the following address: goeran@bodenschatz.berlin