Penn Medicine Clinical Research

Veeva QualityDocs (QD)

About

QualityDocs (QD) is designed for the maintenance and storage of documents used in the manufacture of investigational products.  QD enables manufacturing teams to store documents, as well as to author, review, and approve documents. In addition, the QD system integrates a change control for management of GMP documents.  QualityDocs is built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant system.

QD: Access & Training

  • QualityDocs (QD) is a validated system; each user requires training prior to being granted access.  All users, except for outside inspectors, must obtain a PennKey. Non-Penn faculty/staff can submit an external PennKey Request Form for a guest PennKey.  Access requires an Access Control Form to be completed.  Note that accounts are deactivated after 6 or more months of inactivity.  If you have switched job roles and/or departments, this could impact your access, and modifications to your account may be needed.  Should an account be deactivated, a new Access Control Form will need to be submitted, and training completed prior to reactivation. See Research Technology SOPs.
  • Complete the QualityDocs Access Control Form
  • Submit the form in a ticket in the PMACS helpdesk system, select the PennVault/Veeva queue
  • Penn IS will reach out for training

QD: Support