Document Control
Implement documentation policies to facilitate the referencing of information for processes, systems and equipment, and to comply with regulatory requirements
Type
Functional
Competency Area
Quality Assurance
Levels
Apply document processing and formatting procedures
Organise information in document management systems, ensuring the accuracy of information and its accessibility by appropriate stakeholders
Apply document formatting and version control procedures
Track document distribution
File electronic and hardcopy documents according to standard procedures
Prepare documents required for documentation audits
Implement document control procedures and operate document management systems
Review the maintenance of document management systems
Document and update personal certifications and licenses for employees
Verify the correct distribution of documents
Perform document management audits to ensure documentation requirements are met
Record results of audits
Implement new and revised documentation policies and procedures to ensure compliance with the organisation’s and regulatory requirements
Develop documentation policies and evaluate new and existing documentation practices based on identified requirements
Evaluate documentation requirements for biopharmaceuticals manufacturing processes, systems and equipment
Develop documentation policies and procedures based on the organisation’s requirements
Revise existing documentation policies and procedures based on industry best practices
Develop templates for technical documents
Communicate changes in documentation requirements to relevant stakeholders to ensure compliance with new procedures
Evaluate the implementation of documentation procedures in the organisation
Facilitate documentation audits
Evaluate audit findings and results and highlight
areas of improvement