Document Control

Implement documentation policies to facilitate the referencing of information for processes, systems and equipment, and to comply with regulatory requirements



Competency Area

Quality Assurance


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