A CRO's Dilemma - The CDMS Validation Package that Failed Client Audits 19.OCT Disclaimer

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1 A CRO's Dilemma - The CDMS Validation Package that Failed Client Audits Teri Stokes, Ph.D., Director GXP International Concord, MA - USA Common Sense Computer Validation 19.OCT Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2

2 CRO s First Validation Effort CRO purchased a large clinical data management system (CDMS) CRO purchased a large suite of test scripts from a third party IQ/OQ/PQ scripts were executed CEO also functioned as IT Manager VP doubled in the Quality role 3 CRO s Customer Audits CRO lost contract opportunities due to condition of validation work Cited for not adapting its SOPs to the use of the system Cited for not adapting the test scripts to their own work process Cited for lack of Disaster Recovery testing 4

3 What They Did Next Conducted a new formal validation of the Clinical Data Management System which included: Formal IQ, OQ, and PQ Performed disaster recovery testing Implemented formal change control process Set up a development environment which mirrored the production environment 5 CRO s Recovery Step #1 (Assess) Assess current situation Review prior validation effort Seek external assistance help Screen and select external consultant Obtain assistance from external consultant 6

4 Recovery Step #2 (Plan) Develop overall strategy for validation effort including: Develop user requirements Draft a validation plan Draft a test plan Develop traceability matrix and test cases Develop test scripts 7 Recovery Step #3 (Process) Develop overall strategy for effort including develop a process for: Executing formal testing Documenting testing deviations Documenting final Test Summary Report 8

5 Recovery Step #4 (Document) Drafting high level validation documents indicated a need for: Formal outline of data management life cycle Additional work instructions required to supplement existing SOPs Prepare formal testing envelopes for recording testing 9 Step #5 Test (Disaster Recovery) Define disaster recovery strategy, plan, and develop requirements Acquire additional hardware to simulate production environment Define disaster recovery procedures Exercise disaster recovery procedures on test system Execute the disaster recovery test as an entry point for the formal OQ and PQ processes 10

6 How They Did It External consultant guided them and provided not so gentle reminders of their timelines and need to complete the tasks Significant time spent after hours and on nights and weekend due to other company projects Thorough QC to review each document and ensure traceability back to requirements Much time was invested in training users on formal testing practices 11 Results/Pitfalls Original timeline was for 4-5 months, but project took about 8 months to complete Primary reason for delay was that it was being done in conjunction with ongoing company work Testing team was relatively inexperienced with formal testing and a learning curve took place 12

7 Results/Pitfalls Work required coordination of multiple resources which at times was difficult to coordinate IT challenges of setting up test system caused project delays 13 Challenges Limited resources for this type of effort Limited experienced resources for this type of effort Juggling multiple work projects outside of this effort Coordination with multiple team members in order to complete life cycle 14

8 Challenges Technical expertise to setup, install, document, and maintain data management systems to adhere to Part 11 Implementing a few part 11 requirements in our CDMS as the functionality was there, but required customization (auditing roles, setting default idle times, and password procedures) 15 Overcoming Challenges Extra effort with commitment and enthusiasm from upper management and external QA Coordinated effort with thorough quality control involving several people Hired additional QA staff to facilitate process Team s efficiency and knowledge grew as experience with formal testing increased Sought help from additional IT resources to address technical challenges 16

9 Lessons Learned - 1 Formal testing requires commitment (time and resources) from upper level management Provide sufficient training and ramp up time for testers and authors of testing documentation Full-time or near full-time QA resource is essential for timely completion of effort When implementing systems, acquire additional hardware to setup test/sandbox for informal testing of scripts and processes 17 Lessons Learned - 2 Reward and praise team for the extra effort required for this effort Ensure enough IT resources and support are available to setup and maintain test systems Budget for time required by administrative staff for documentation preparation, photocopies, and support 18

10 Lessons Learned - 3 Remind staff of benefits of formal testing and its impact on quality Use the exercise to fine tune SOPs and identify missing SOPs and processes 19 Thank You Merci beaucoup Vielen Dank Danku Grazie Gracias Obrigado Tack, Tak, Takk 20