Case Studies

CASE STUDY

Clinical Protocol and Study Report Document Life Cycle

Project Profile

Project for a top 25 biopharmaceutical company looking to support the management of documents throughout their lifecycle stages - Plan, Develop, Review, Content QC, Publish, Publish QC, Approve, Release, Maintain and End-of-Life.

50 + products and a user base of 1000 + users worldwide.

9-month project implementation including validation, training and post go live support activities.

Multiple systems, tools and manual processes to manage the overall process resulting in inconsistency and usage of outdated versions.

Inability to capture or track metrics and statistics making it difficult to schedule and plan activities.

Redundancy, duplication and inability to share and re-use content across documents, groups and countries.

Current State

End-to-End collaborative authoring and reviewing process from planning, authoring, review, QC, publishing and other features.

Standard workflows that can be configured for specific document types.

Management of content libraries, relationships and hierarchies.

Standard document version numbering, naming, status and description.

Supporting the addition and display of documents in the EDMS system via actions taken in the solution.

Support the addition, modification, and display of descriptions and document metadata.

Event-based and user-initiated notifications of changes to documents.

Support for both simple and compound document types.

Traceability – Identify both where a document version has been used within larger documents, and which component documents have been included in a specified compound document.

A granular permissions model to support project roles and teams.

Support for removing outdated and redundant document versions.

Tracking of dates and activities, enabling collection of metrics and top-down visibility.

Searching, retrieval, navigation, and reporting capability.

Dashboards and reports with audit trail tracking all activities.

Key Benefits

Reduce the risk of inadvertent use of inconsistent or outdated document content.
Increase the efficient use of resources, e.g., reduce document cycle time.
Automatically capture process milestones to enable metrics and reporting.
Share knowledge easily and quickly between geographically dispersed groups.
Reduce training time of staff by facilitating transfer of knowledge.
Support consistent document storage and management globally.
Facilitate regulatory compliance in a robust and explicit manner.
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