Enterprise Level Change Control: A Life Science Business Imperative. Presented by: Carl Ning Solutions Delivery Manager Sparta Systems

Transcription

1 Enterprise Level Change Control: A Life Science Business Imperative Presented by: Carl Ning Solutions Delivery Manager Sparta Systems

2 Agenda Global Change Control: An Overview Benefits and Challenges Change Control as Part of a Quality Management Solution Implementing a Change Control Solution Questions & Answers 2

3 Change Control Overview 3

4 Implementing a Change Control Solution The most effective automated change control systems comprise the following types of critical functionality: Electronic Centralized Consistency Control Electronically and securely managing all information in a centralized, scalable, and reliable system eliminates the potential loss of information Centralized management of all change control items eliminates redundant systems and decreases production costs Consistent and harmonized processes and procedures across the organization reduces liability and patient risk Applying the right controls, at the right time, to ensure compliance while also maintaining a culture for innovation 4 4

5 High-level Change Process Request Change Request vs. Change Management Why is the change happening? Change Request Assessment Pre-approval Change Management Who does it impact? What actions are required? Regulatory implications? What approvals are required? Real-time status? Execution Post-approval 5

6 Enterprise Change Control: Desired State Hierarchical relationship of one change request and its associated activities Electronic attachment and organization of supporting documentation Change Request Electronic attachment 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 Impact Assessment Regulatory Assessment Implementation Activities 6

7 Benefits and Challenges 7

8 Business drivers for Enterprise Change Control Time to Market Companies require a consistent mechanism to implement change Supports Global Supply Chain Initiatives Enables plant rationalization and supply continuity Supports product enhancements and evolution Supports Merger & Acquisition (M&A) strategies Provides mechanism to harmonize onto common systems and processes Compliance Significant consequences to non-compliance including fines, production stops and even requirements to register new product variations Global visibility of change is expected 8

9 What s slowing companies down? Alignment Getting a global company to set aside resources at the same for the same purpose requires executive sponsorship and commitment Efficiencies Local site leadership may believe their local process is optimized for their needs. Why should they give that up? Regulations In some companies, especially those that have grown via M&A, products are regulated differently either based on product type or region. Companies must devise a strategy to hold each product to the appropriate regulation not too little or not enough Perception In many companies change control is seen as not value-add. This perception must be actively managed during any project Process Reengineering Before investing in an electronic system, the best-practice is to use that opportunity to refine your business process. This requires the right team and targeted effort but pays dividends in the long-run. Smart companies know that software-alone won t solve their problems 9

10 Change Control as Part of a Quality Management Solution 10

11 EQMS Overview: How it all fits together 11 11

12 Change Control as Part of a QMS Change Control is logically correlated to multiple elements of a company s overall quality system including CAPA, deviations, audits and batch control. Organizations with best in class quality systems processes are including global change control as fully integrated element of their enterprise quality management systems (EQMS) 12 12

13 Implementing a Change Control Solution 13

14 Implementation Methodology Strong executive sponsorship is a critical prerequisite to initiating a deployment Scope must be clearly identified and documented to serve as a baseline to prevent creep Project team resource needs and timelines need to be clearly communicated and agreed upon in advance of project start Prototype reviews during design/build are critical to insure requirements are met and gain buy-in from project team 6 Stage Implementation Methodology 1 Analyze requirements Design/build Test Validate Train Go live/support 14

15 Initial Discovery Evaluation of existing processes Documentation of As-Is process Collect all plant and site level SOP s Document site specific processes based on the SOP s Prepare and distribute questionnaires to help learn more about local process Summarize all findings, including major differences Identification of challenges, issues, risks of the overall process as well as impacted functions Evaluation of IT landscape Identify all systems, including interfaces, used by the impacted departments Identify a state of infrastructure to support a global system Master data analysis Identify source(s) of master data Define strategy for to be model 15 15

16 Process Harmonization Input From Key Stakeholders Across geographies and functions (QA, RA, Validation & Tech Services etc.) To-be Process Definition Identify major changes and areas for improvement Process mapping, including control points Tradeoffs from current state? Leverage Executive Champion Nearly all projects include resource efficiencies, although sometimes there is also a shift of work from group A to B which champion can help manage Initial Face to Face Workshop Alleviates interpretation issues Builds relationships across team Subsequent activities are then easier to conduct remotely 16

17 Implementing a Change Control Solution Automation Automation of required impact assessments based on the change type, impact, and other criteria improves the impact assessment process Automated notifications for departments and sites when problems occur increases visibility and reduces product impact Automated workflow and parallel review and approval processes improves efficiency and reduces change control closure time Automated and enforced specific actions help comply with ISO and other industry regulations 17 17

18 Integration - Sophisticated ERP Direct master data validation ERP Batch in ERP Release Fully automated placement of hold notices in ERP by EQMS Master Data Integration Place Hold Disposition Updated Fully automated disposition updates from EQMS Release process with clear, inherent visibility into quality issues User Entered Product Information Initiated Change Validated Data SOA Affected Batches Initiated Change Disposition Updated Completed Change 18

19 Integration - EDMS Basic Access to controlled documentation in EDMS from the change management system Seamless no additional authentication Advanced Change Management Workflow > Document Lifecycle Interaction Two way visibility to status 19

20 Conclusions 20

21 Conclusions When implemented and managed successfully, electronic change control can be a competitive advantage to differentiate a company from their competition by enabling improved cycle time and time to market, supporting global supply chain initiatives, enhanced product quality, and the flexibility to adapt to changing regulations. 21

22 Questions & Answers 22