This modules looks at the management of validation and verification of decontamination processes used and their compliance with Regulatory Standards.
Validation Masterplan for Hospital Departments
the validation of the decontamination facility and all equipment installed for the purposes of medical device decontamination will be explained.The qualification of equipment activities and procedures will be addressed by the production of comprehensive masterplans.
Validation of Track and Trace Systems
Information and data storage systems will be explored in the context of inventory management of medical devices and management of the decontamination pathway. Software and hardware requirements will be included
Environmental & Utilities Validation
Validation requirements of clean steam, RO water Medical air and HEPA filtered air supplies will be examined.
Validation Reporting
Provision of documentary evidence to support specifications provided by manufacturers and to comply with regulatory standards will be the focus here.
Auditing for Regulatory Compliance
Compliance audits will be explained and strategies used for effective auditing of the decontamination pathway will be outlined. Emphasis will be placed on verifying the accuracy reliability and integrity of validation data and its secure archiving and retrieval for the production of audit reports.
Management of Validation Data
Verification of data accuracy and reflective analysis of the validation methods used will be explored to ensure compliance with Quality Management System Requirements.Independent validation and verification will be explained for retrospective and concurrent validation of decontamination processes.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |