Prelude developed and implemented a central tracking system to centralize management and storage of GxP documents and records.
Consolidated retention schedules and physical documents reducing compliance risks.
The company moved over 20,000 GxP records from individual departments to central storage, cataloguing, archiving, and changing the appropriate SOPs within an 18 month timeframe.
Prelude provided project management for the consolidation and global rollout of the GenSight Portfolio Management System in a major pharmaceutical company.
Multiple instances of the application were consolidated so all users were on one common system which provided greater consistency and harmonization across the organization. The roll out included additional users in Asia Pacific, Europe, Middle East, Africa, South and Central America, and North America.
Prelude spearheaded a team that examined all day-to-day work processes in the documentation department. We removed inefficiencies and streamlined the process for receiving and tracking documents across four physical sites. This redesign freed up two of the seven staff members.
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Prelude worked with management to develop an overall Document Management Strategy and life cycle management. Strategy that included the paper records life cycle management and tracking as well as the implementation of a new Documentum document management system.
The Prelude team developed computer based and instructor led training and documentation materials for the GenSight Portfolio Management System being deployed globally for a major healthcare provider.
Materials included: Nine CBT courses, instructor slides, training workbook, quick reference handouts and user guides for each type of user. We also assisted in the acceptance testing for the new system.
By better utilizing an existing SharePoint site, Prelude was able to improved productivity by moving paper and Word based request forms to self service SharePoint web forms based solutions. We reduced turnaround time and captured response and volume metrics for continual improvement and an improved user experience.
Prelude managed an SOP Integration and Harmonization team consolidating GxP SOPs resulting from company merger.
Reduced the total number of documents by 50% and number of SOPs by over 95% implementing hierarchical system.
Prelude Computer Solutions, Inc.