In September, 2009, PIC/S published a new version of their guide for GMP-inspectors to use during inspections of pharmaceutical manufacturing facilities. The annexes provide additional information that is generally applicable for both finished medicinal products and actives substances.
See section 11 for specifics on computerized systems.
Meeting minutes are a key communication tool for any project. This template provides an easy format for recording attendance, discussion, activities, and action items.
This SOP defines the procedures and controls for managing change to the Information Technology systems used in regulated activities. Topics include change requests, impact assessment, authorization, cancellation, closure, record retention, and emergency changes. Five forms for ch
This SOP defines the procedures to leverage system quality risk and complexity factors in developing a validation approach for Information Technology systems used in regulated activities. Topics include major function criticality and complexity assessments, the impact of vendor assessment results, validation approaches, and alter
This SOP defines the procedure to assess and analyze system quality risk for Information Technology systems used in regulated activities. Topics include risk assessment timing, risk assessment procedures, criticality classification of systems and features, and risk assessment documentation. A form for documentation of system and feature risk assessment and criticality analyses is included with this SOP.
This document contains an overall program of procedures and controls for managing system quality risks for the Information Technology systems used in regulated activities. Topics include definitions of risk-related terms, responsibilities, and an approach to software risk assessment and control.
This blank SOP template can be used to write customized standard operating procedures.
This SOP defines the procedures and controls for managing incidents regarding the Information Technology systems used in regulated activities. Topics include incident reporting, incident investigation, incident resolution, record retention, and periodic incident management effectiveness reviews. Four forms for incident management are included with this SOP.
This SOP defines the procedures and controls necessary to ensure that employees have the training needed to effectively perform their assigned responsibilities regarding the Information Technology systems used in regulated activities. Topics include application of risk assessment, training materials, training requirements, training records, change control for system changes, and periodic training effectiveness reviews. Five example forms for user training management are included with this SOP.
