AI Checklist Generator

Email address

Home > Quality Control Checklist – Pharmacovigilance System Master File (PSMF) for Vectans Pharma

Quality Control Checklist – Pharmacovigilance System Master File (PSMF) for Vectans Pharma

Confirm the PSMF version is up to date.

Verify the PSMF is approved by the appropriate authority.

Ensure the PSMF is accessible to relevant personnel.

Review the organizational chart for the pharmacovigilance department.

Confirm roles and responsibilities are clearly defined.

Ensure contact details for key personnel are current.

Check that all pharmacovigilance processes are documented.

Verify compliance with applicable regulations and guidelines.

Ensure procedures for adverse event reporting are in place.

Confirm data collection methods are validated.

Verify that data entry is consistent with source documents.

Ensure that data is securely stored and backed up.

Review the quality assurance processes for pharmacovigilance.

Confirm regular audits are conducted and documented.

Ensure corrective and preventive actions (CAPA) are implemented as needed.

Verify that training records for pharmacovigilance staff are up to date.

Ensure ongoing training programs are in place.

Confirm that staff competency assessments are conducted regularly.

Check that reporting timelines are adhered to.

Confirm that communication channels for safety information are established.

Ensure stakeholders are informed of relevant safety updates.

Verify that the PSMF complies with local and international regulations.

Ensure that regulatory submissions are timely and accurate.

Confirm that any regulatory feedback is addressed promptly.

Schedule regular reviews of the PSMF.

Confirm that updates are documented and communicated.

Ensure that changes are approved by the relevant authorities.

This checklist provides a structured approach to ensure quality control in the Pharmacovigilance System Master File for Vectans Pharma.

Hey there! Here's a little about us or visit our recurring workflow SaaS: Manifestly Checklists

Light Dark