1. www.diahome.org DIA 6 th European Validation Workshop, Amsterdam, 2007. Building Change into Process David Bridges Director, eChange Solutions Limited eChange Solutions Limited

2. www.diahome.org Introduction Impact of change on validated systems How to manage change Contrast with processes and recourses used in new system introduction / major upgrades. Drawing examples from the European Biometrics Department of an (un-named) global research based pharma. Company.

3. www.diahome.org Biometrics systems Query Management RDE CDMS Reporting & Statistical Analysis Submission Compilation & Publishing Work Tracking Resource Management Image Management

4. www.diahome.org Biometrics systems Query Management RDE CDMS Reporting & Statistical Analysis Submission Compilation & Publishing Work Tracking Resource Management Image Management

5. www.diahome.org Biometrics systems Query Management RDE CDMS Reporting & Statistical Analysis Submission Compilation & Publishing Work Tracking. Resource Management Image Management

6. www.diahome.org Data Extraction Major System Change Query Management RDE Image Management CDMS Reporting & Statistical Analysis Data transfer Data entry OCR Query Generation Major change is usually focuses on a single system and it’s interfaces

7. www.diahome.org Scope : Requirement Design Development Testing Training Release Support planning System introduction / major upgrade CDMS Validation

8. www.diahome.org System introduction / major upgrade CDMS Usually : Organized as a project High level sponsorship (business & technical) High visibility “Business” involvement Best practice in –Change management –Configuration management –Risk management May also : Form part of a change programme Benefit from project office

9. www.diahome.org Data Extraction Validation of system Query Management RDE Image Management CDMS Reporting & Statistical Analysis Data transfer Data entry OCR Query Generation Validation focuses on a single system and it’s interfaces

10. www.diahome.org Validation paradigm Investigator FDA A chain of validated systems : Each of which has been validated to demonstrate its fitness for purpose. That together ensure the authenticity, integrity, confidentiality and signer non-repudiation of records from the investigator to regulatory authority.

11. www.diahome.org So What is the problem ! These system do not exist in a static environment. In fact, the environment is less “under control” that the systems ! Changes to : –Organization structure –Staff –Processes (SOPs) –Use of system –IT infrastructure –System functionality (minor changes, bug fixes) All have potential to compromise the effective operation of the system.

12. www.diahome.org Scale of change : Biometrics At any one time involved with approx. 20 drugs. 4 in phase III and a further 4 post primary submission. Estimated duration of involvement with drug that is approved is 15 years Biometrics involved with drugs in phase 1-3 & also drugs where primary submission complete but further submission (country, indication) required. IPost SubmissionIIIII

13. www.diahome.org Think about it ! What changes have occurred in your organization in the last 15 years ? –Organization structure –Staff –Processes (SOPs) –Use of system –IT infrastructure

14. www.diahome.org RDE3 Image Management2 CDMS3 Query Management4 Report & statistical analysis2 Submission Compilation and Publishing1 Work Tracking>4 Resource Management>5 System Duplication Systems change but data migration is risky and expensive This leads to system duplication

15. www.diahome.org Managing change Management of change to : Organization structure Staff Processes (SOPs) All require similar processes and resources Change management Configuration management Risk management Use of system IT infrastructure System functionality (minor/bugs) Change control boards Designated staff Inventories Decision makers

16. www.diahome.org Managing change Management of change to : Organization structure Staff Processes (SOPs) All result in similar outcomes Document and proceed Undertake partial risk-based validation Undertake full validation Use of system IT infrastructure System functionality (minor/bugs)

17. www.diahome.org Analysis of validation events Over a three year period there were 41 changes to systems or processes requiring full or partial re-validation impacting the Clinical Data Management System (CDMS). Half related to upgrades of the CDMS system itself, while the remainder related to auxiliary systems and infrastructure products such as the database, SAS and the operating system.

18. www.diahome.org Analysis of validation events Of the 41 events 11 were infrastructure driven : –4 database –9 Server –Of these 2 were driven by infrastructure change required by another validated system 2 were database migration projects 12 were releases of new functionality (including bugs) 16 were bug-fix releases Significant number of infrastructure and process deemed not to require re-validation by CCBs.

19. www.diahome.org Final points Can not achieve compliance by focusing on change management of the system alone. Most organizations have multiple CCB’s (& they don’t talk to each other !). One man’s focus of responsibility is another man’s risk.

20. www.diahome.org Practical advice Determine what the sources of change are and how they are controlled Encourage best practice within each domain Encourage communication and mutual support Put in place safety net (Support Plan)

21. www.diahome.org Questions ? Many Thanks Slides can be downloaded from : www.echangesolutions.com from Monday Or leave me a business card and I will e-mail them to you.