Vault QualityDocs is an application to manage documentation associated with a quality system, providing seamless collaboration, reducing compliance risk, and improving quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees and partners.
Vault QualityDocs is built on the Vault platform and therefore has the features that are described in the platform help topics. In addition, it includes these capabilities specific to managing documents for medical information inquiries:
- Change control: This configurable feature helps organizations to regulate the processes of creating a new draft, moving a draft into its Steady state (releasing it for use) or withdrawing an existing, approved document.
- Overlays and signature pages: Content that is taken outside of Vault will have information stamped on it to ensure that it cannot be used in an uncontrolled manner. Organizations can also configure Vault to add signature manifestation pages to downloaded content.
- Product object: To allow content to be shared globally or localized for a specific market, Vault QualityDocs provides objects that store the master data and allow reuse and searching of that data across multiple products and documents.
- Country-/Facility-/Department- specific actions: To allow for differing approval processes globally and across many business units, Vault QualityDocs allows for configurable lifecycle and workflow actions based on the country or responsible facility/department for the content.
- Content expiration: Vault QualityDocs provides a process for notifying users of potentially out of date content. The owners of old documents are given notifications and are required to review the content in order to keep it current and effective.
- Role defaulting: When content is created or sent on a workflow the roles can be defaulted based on the product, country, facility and/or department that the content is associated with.
- Trainee role: Trainee is a specialized role for use with Read & Understood workflows. Workflows can only assign Read & Understood workflow tasks to users in the Trainee role. Vault automatically creates this role for all lifecycles.
- Controlled copies: This functionality allows companies to manage controlled copy generation, distribution, and tracking. It allows security-governed users to generate numbered copies of content for use by contract organizations or facilities which lack access to your Vault. In legacy controlled copy configurations, you can report on controlled copies and track their status (in recall, recall confirmed, etc.) using Distribution-type reports. In Vaults using Extensible Controlled Copy, you can configure specific controlled copy types, security, and lifecycles to collect, manage, and report on detailed data for each type of downloaded controlled copy.
- Read & Understood workflows: Read & Understood workflows allow you to assign a document to specific users for review. When users complete their review, they can mark the document as “Read & Understood” and provide an eSignature as proof that they’ve completed the task. These workflows differ from standard workflows in two ways: Read-only users may participate and provide eSignatures, and multiple workflows can be active simultaneously on a single document. Specialized reports geared towards Read & Understood organizational compliance allow training administrators to keep track of their organization’s compliance status as new or changed content is approved for use.
- Entry Criteria for Related Documents: This feature allows you to require documents related to a specific object record to be in specific state types (Ready for DCC Approval, Effective, Obsolete, etc.) before the object record can move into the destination state.
- Process Navigator: Documents that support a process can be associated with one or many processes and can be viewed as a user browses their process hierarchy relevant to their role. A purpose-built user interface allows casual end users an experience that allows them to view process information along with their supporting documents in an intuitive, visually guided way.
- Periodic Reviews: An enhanced suite of options for automating the start and tracking of periodic reviews for documents.