Accrediting the CRS Quality Management System
Read-Download the SASI-QMS:2023-2 Standard Read FDA Official's Comments on CRS Quality Expectations
After competing the Exploratory Program, the CRS should be able to efficiently undertake its self-assessment and conformance plan. When the CRS has determined that it has gained appropriate value from the optional KTP Community Networking and other sources, it will then notify SASI that it is ready to begin the steps of review and assessment that it is in conformance to the Standard.
The Candidate then uploads into the secure Accreditation Management Directory the documents and other evidences that can be reviewed by the SASI Surveyors. This begins an interactive process of verification and validation which includes live and recorded discussions within a specific approval process for each clause of the Standard. This technology-assisted method allows the Candidate to distribute the workload among its available staff and create a flexible schedule of planned interactions with the SASI Surveyors that produces an orderly, efficient and "intelligent" accreditation process.
The Reasonable and Effective Use of Technologies
The SASI Accreditation Management Directory enables SASI Surveyors and Candidate Sites to log on separately to update and review files* in the
secure cloud or to meet
together** to discuss progress and determine next steps. Candidates can complete the requirements for separate clauses of the Standard and
then notify the Surveyor(s) via a simple email notification that a specific clause is "ready for review." The Surveyor can
then complete the review of the clause and document responses via the notification.
This methodology allows for multiple iterations and
options for distributing and scheduling
work within the Candidate Site's available resources. From the date that a Candidate Site declares that it is "ready for review," it has a one year period
to complete the review and conformity assessment to the requirements of the Standard and receive Accredited status. Typically 90% or more of the review activities
and discussions will occur in live video-conferences and through the SASI-WARE secure portal and user interface. However, the last
step in the accreditation process is a "site visit" in which a Surveyors will confirm and validate the findings of the online
reviews.
* All written communications including Surveyor asssessments and documentation updates between SASI and the Candidate Site are documented and centrally controlled through the Accreditation Management Directory.
** All verbal communications and conferences between SASI Surveyors and a Site Candidate's leadership or staff are fulfilled by live, on-camera and recorded video-conferencing.