Why SALSA
Advantages for you!
- SALSA allows you to respond to the current COVID-19 pandemic, or to any other circumstances requiring significant modifications to your existing annual audit plans
- SALSA adds value to the efficacy and objectivity of the auditing and audit planning processes
- SALSA enables “smart” selection of the subjects and data to be reviewed during site audits
- is an audit needed at all?
- can the site audit be conducted remotely (RISA)?
- a full RISA or stepwise, with or without site/CRO staff interaction or just a data review (risk-based approach to RISA and SALSA)?
- is an on-site audit needed? With priority?
- SALSA means you can either use GXP Engaged Auditing Services for your next QA steps or do it yourself
- SALSA supports single use for auditing and QA activities or ongoing use for your QA processes
- SALSA facilitates an effectiveness check for your CAPAs after inspection or audit
What is SALSA?
SALSA (Statistical Assessment Layer for Site Audits) is a validated statistical tool which provides a robust basis for decisions related to a modern risk-based auditing approach. Originally developed to respond to the increasing demand for remote site auditing, it can also be used as an additional layer to decide whether an audit is required, or if the risk level is below the defined threshold, taking – beyond other factors – data quality and data integrity into consideration.
SALSA makes your audit planning “smarter” as it utilises an evidence-based rationale for data quality and data integrity risk identification that allows you to make the right decision.
SALSA also provides an evidence-base for data selection for review during the audit and for the questions asked to site staff and the CRA. If the opportunity for interaction with site staff is limited SALSA helps to come to the point immediately; ask the right questions, which carry the highest risks.
Use SALSA
For rapid analysis and visualisation of selected study data
To evaluate data patterns for sites and individual subjects
To identify unusual data patterns and statistical abnormalities
To show you differences between subject populations at different sites
To show you outliers for individual subjects or data points
SALSA helps you:
As SALSA analyses can be used by the client in addition to other parameters in their risk-based quality management approach to provide objective, data-based evidence to support decisions to postpone or cancel individual audits, or to convert to a Remote Investigator Site Audit (RISA) strategy.
In the selection of investigator site audits as well as for the preparation of individual site audits, contracted to GXP Engaged Auditing Services
When a full RISA is not possible, necessary or wanted, it allows a stepwise RISA approach, with or without site/CRO staff involvement or even just a remote data review
As your SALSA report can be independent of site audits and you can use GXP Engaged Auditing Services consulting services to obtain recommendations on possible and appropriate next steps or you can conduct further QA activities yourselves
As SALSA can also be used for ongoing site compliance and quality status monitoring, either as part of QA routine processes or to remotely review effectiveness of corrective and preventive actions implemented after an inspection or audit, which are expected to become visible in the study data.