Document Management Solution (EDMS)

Transcription

1 Implementing TrackWise with an Electronic Document Management Solution (EDMS) Alex Kotikovsky Product Manager Sparta Systems Gilad Kigel Manager, Solutions Consulting Sparta Systems

2 Agenda Document Management Overview Document Management within TrackWise Benefitsof anintegrated Solution Best Practices Demo of TrackWise Document Management Q&A

3 Compare/Contrast Document Management and EQMS

4 EQMS Vision Audit Management Deviations & Incidents Lab Issues Complaint Handling Supplier Quality Management Investigations Adverse Event Reporting Training Management Risk Evaluation Root Cause Analysis CAPA Product Registration Tracking Correspondence Commitments Change Control Batch / IT / Process / Document Material / Equipment Effectivity Analysis

5 Typical Document Management Strategies Many of our customers have existing document management systems in place that t they want TrackWise to link to: Other companies that don t already have EDMS may want to leverage their EQMS investment to support both. This presentation will focus primarily on helping these companies understand how TrackWise can support documentmanagementneeds management needs

6 Introto to DocumentManagement What is it: fundamentally, the ability to control documentation and distribute to appropriate employees Key features?: revision control and check in/check out functionality Some companies distinguish between types of documents Controlled SOPs, Policies, Forms, Work Instructions things that t require change control approval to be released Standard or Project documents meeting minutes, validation reports, testing summaries, project plans Donot require change control approval to bereleased, even thoughsome may support change control (e.g., a validation plan may be electronically approved for CAPA or Change Control but doesn t require the same approval steps as an SOP update) For the purposes of this presentation we will focus on Controlled documents, or those that require Change Control approval to be released

7 DocumentManagement vs. EQMS Document Management EQMS Key feature Revision control Workflow management Key searching capability Key value proposition Historical tools before electronic systems Key risks to process Display all SOPs needed to perform job Ensure products are made per specification and company operates under control Shared network drive, paper printouts 1. Using outdated procedures 2. Not knowing procedure exists 3. Not following procedure Ability to identify trends in database Enables closed loop processes Paper with excel tracking 1. Not completing things in a timely manner 2. Incomplete documentation 3. Bypassing process/ late documentation

8 EQMS Nonconformity CAPA Change Control

9 DocumentManagement vs. EQMS New SOP 1.0 in progress WIP Approve 1.0 Effective 2.0 in progress 2.0 Effective 1.0 Retired 2.0 Retired Revise SOP WIP Approve 3.0 in progress 3.0 Effective 3.0 Retired Revise SOP WIP Approve Revise SOP 4.0 in progress WIP Approve 4.0 Effective Discussion point: should documents become effective as soon as they are approved?

10 High level Change Process Change Request Request Assessment Pre approval Execution Change Management Change request vs. change management Why is the change happening? Who does it impact? What actions are required? Regulatory implications? What approvals are required? Real time status? Post approval

11 Enterprise Change Control: Desired State Hierarchical relationship of one change request and its associated activities iii Electronic attachment and organization of supporting documentation Logical association of supporting information directly to change request Automated, consistent, and efficient change control process Clear visibility to all levels of the organization through centralization of information and dashboards Accommodation of both proactive and reactive change activity Clear Linkage Change Request Impact Assessment Regulatory Assessment Implementation Activities Electronic attachment

12 TrackWise Document Management Options TrackWise file attachments: ts Leveraging repository to securely store and associate documents to TrackWise records. Document Management Connector: Integrate with existing content solutions (ex: Documentum, SharePoint, LiveLink) Integrated EQMS and Document Management: A single, integrated solution to relate content management processes directly to EQMS (CAPA, Change Control, Regulatory Correspondence, Auditing, Training, etc..)

13 TrackWise Document Management Key Features Workflow Automation Check in and Check out Version Control Access Control Escalations Notifications Auto Embedding Embeddingof Metadata Search and Query Dashboards

14 Benefits of an Integrated Solution

15 Typical Quality Process Data received and monitored by EQMS Deviation or anomaly detected Analysis preformed as directed Interpret, document, and discuss results Modify processes and documentation as appropriate p Publish and audit system changes Quality information tracked and monitored Deviation logged into system Cause and correction analysis performed Ad hoc review and discussion of results Publish and archive

16 TrackWise Document Management and EQMS Audit Management Deviations & Incidents Lab Issues Complaint Handling Supplier Quality Management Investigations Adverse Event Reporting Risk Evaluation Document Control Training Management Root Cause Analysis CAPA Change Control Batch / IT / Process / Document Material / Equipment Effectivity Analysis

17 Benefits of Integrated TrackWise EQMS & EDMS Ensure compliance through document control Seamless integration Reduced training cost Improved system performance Reduction of time to transfer documents

18 Case Study: NVI (Netherlands Vaccines Institute) Business Challenge Its previous system for managing records a combination of Microsoft Excel, Microsoft Access and old fashioned, paper based methods had become insufficient for managing documentation and readying reports for submission to the EU. NVI decided to seek out a centralized electronic system for document management that would not only ensure efficient and effective compliance with reporting standards, but also seamlessly integrate with its current systems Why TrackWise Compliant with European Standards, easy to generate submission reports Easy integration ti with other systems, minimal i configuration Ease of use, intuitive GUI

19 Results NVI Implementation Results: NVI was able to create a centralized repository for all its critical documents, immediately migrating more than 20,000 documents into its new system, and eventually doubling that number to 40,000 over the next two years. Leveraging and Expanding TrackWise Investment beyond Document Management: Addition of 13 workflows within it its quality assurance department, including: Deviations Corrective and Preventive Actions (CAPA) Change Control Internal and External Audits

20 Best Practices

21 Best Practices All linked processes in a single system Notifications on Sunset Dates, Updated Content, etc Dashboards of document state and status Document Templates for consistency and repeatability Use the EDMS Connector to leverage an existing investment

22 Documents ina Corporate Hierarchy SOP Work Instructions Policies Batch Records Regulatory Submissions Correspondences CAPA Evidence Validation Docs Manuals Instructions Investigation Reports Audit Reports Product Registrations Plus more

23 How Do Companies Manage The Complexity?

24 Define, Track, Manage and Report Across Your Organization Customer called about missing instructions Complaint Complaint Entry Initial Assessment and Data Collection Send notification to QA for impact Analysis Immediate Action Taken Manufacturing site conducts an investigation to determine cause of problem Investigation Trend Detection Root Cause Determination CAPA Determination

25 Define, Track, Manage and Report Across Your Organization Add procedure to verify instructions included before shipping Quality Assurance CAPA Corrective Actions Preventive Actions Change Control Risk Assessment Need to continuously verify effectiveness of CAPA actions A Change Request for the new SOP is required Quality Assurance Effectiveness Check Check Plan Check Execution Approvals Document Control Change Control A Change Request for related existing SOPs Change Plan Risk Assessment Design Change Execution

26 Define, Track, Manage and Report Across Your Organization A new SOP is added for this new process step An existing SOP is updated to accommodate the new process step Document Control Document Change Plan Risk Assessment Design Change Execution Revision to existing SOP triggers retraining Employee Training Issue retraining record to appropriate employees based on job description and curriculum

27 Questions?