Collection: Regulatory Mock Audits
Let’s be blunt. Automation System vendors generally have only a passing awareness of the requirements of qualified systems and can be a little haphazard with maintaining appropriate levels of change control. Conversely, Validation services generally have only a passing awareness of building automation systems because of the strong focus on process systems and automation. The proprietary nature of many building automation system platforms leads to additional obscurity.
Combining a system data review along with a building automation system documentation assessment BSUBAS provides mock regulatory audits complete with a detail deviation and discrepancy report along with a corrective action plan. BSUBAS Mock Audits are based on a) Client Quality System Requirements, b) FDA 21 CFR regulations, and c) ISPE GAMP recommendations.
Upon request we can also encompass appropriate alternate regulatory requirements (e.g. for non-US markets) or alternate best practices to align with the BSUBAS Mock Audit.
NOTE: The BSUBAS Mock Audit is intended as an internal client review of the associated impact systems and is not in any way associated with efforts and policies of various regulatory agencies.
