Quality and Compliance

Quality Document Manager ()

Quality Document Manager enables companies to globally define and manage controlled documentation with a scalable change process and enterprise-wide training management. Collaboration with electronic signatures enforces compliance in accordance with industry standards and regulations.

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Regulated companies live and die at the hand of being first to bring a “best in class” product to market rapidly without jeopardizing compliance. Companies must ultimately achieve mature product quality with a low compliance burden. Quality Document Manager establishes and enforces company standards to enable consistent development and production of high-quality products that will meet or exceed regulatory and quality requirements.

Quality Document Manager automates and effectively manages the enterprise change management, review release, training, and distribution of approved documents. Quality Document Manager simplifies the document change and revision process, and more importantly, reduces risk associated with the use of erroneous and outdated documents.

Proposed changes are evaluated, justifications are documented and change plans are defined and executed. Change approval assignments are configured for reviewer and approvers that require electronic signatures to release approved documents across the business. Change management process is implemented to ensure a consistent multiple site implementations of the approved document based on effectivity dates that supports periodic reviews to ensure on going compliance and accuracy of the document intended usage.

Quality Document Manager ensures and records that all effected locations and staff are aware of changes and trained with new or revised control documents. For each new or revised document that is released, the system automatically sends email notifications to personnel who are affected by the released controlled document. The automatic training process engages staff for acknowledgement when documents are approved, and requires electronic signatures with read and understood statements to verify stakeholders have performed any related mandatory training tasks. Training assignments by location are easily defined and they are tracked until completion to support quality audits.

Key features & benefits

  • Securely automates a change control process based on industry best-practices such as FDA Part 820, Part 211 and ISO standards

  • Closed-loop routines to manage document revisions and change control with automated approval routings and email notifications

  • iMajor, minor revisions are tracked; departments, groups and individuals affected by each document are recorded and can receive automated changes notices

  • Personalized document control workflow, document lists, implementation, and templates.

  • Create and define templates by organization or create change order templates and store all templates.

  • Time saving creations with all reusable information, ability to incorporate further documents as required, and the ability to track progress and status information per document.

  • Change orders tracked by organization and/or approvers.

  • Full traceability and auditable document revision control.

  • Change order implementation and impact analysis