iPassport
Why is Document Control So Important?Research shows that the most common laboratory inspection citations now include: •Incomplete documents •Important information missing from a procedure •Multiple versions of the same document in the lab simultaneously. Staff using both •Failure to review procedures annually •Failure to make complete procedure manuals available at the workbench •Failure to archive previous versions •Failure t…
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Why is Document Control So Important?
Research shows that the most common laboratory inspection citations now include:
•Incomplete documents
•Important information missing from a procedure
•Multiple versions of the same document in the lab simultaneously. Staff using both
•Failure to review procedures annually
•Failure to make complete procedure manuals available at the workbench
•Failure to archive previous versions
•Failure to demonstrate staff procedure & policy review
•Failure to demonstrate management procedure & policy review
iPassport is designed to address all aspects of document control in an orderly and easy-to-use structure for every policy, procedure and more.
Document Control Features
•Comprehensive document control with full version information
•Control of document status: Draft, Authorized, Superseded
•ISO compliant document review and update structure
•Automated notification of review tasks both within iPassport and via email
•Full electronic signature capabilities
•Controlled and fully traceable document printing
•Automated notifications for technical staff at each document update
•Ensure technical and administrative staff have access to the most up-to-date authorized document version at the point of use
•Automated History features allows clients to view a summary of events for each document
Compliance Management Features
•Checklists and Standards management
•iPassport automatically sorts full checklists into individual standards to allow for assessment of each standard on a case-by-case basis
•Link individual standards/ checklist questions to the relevant controlled documentation (policies, procedures, forms etc.) for evidenced based compliance
•Attach compliance evidence from external sources
•Comprehensive auditing features allows identification of non-compliance events
•Record external audits/assessments
•Corrective Action and Preventative Action (CAPA) management
•Track all CAPA tasks to completion
•Link/ attach relevant documentation to completed CAPA tasks for evidenced based compliance
