Digital transformation in practice, i.e. how to teach elephant to fly?

Transcription

1 PRESENTATION Digital transformation in practice, i.e. how to teach elephant to fly? Keresztesi Kálmán Controsys Irányítástechnikai Kft.

2 Agenda Project background Current practices Digital transformation in automation project collaboration Digital transformation in quality management Human factors of the transformation process Experiences Conclusion

3 Source: Wikimedia by Srilekha selva Cross-wiki upload from en.wikipedia.org

4 The project Location: Richter Gedeon Biotechnology Plant, Debrecen In operation: System Upgrade for HW and SW components Capacity extension - new equipment Typical process automation tasks HW replacement: Servers (new virtual IT environment) HW Extensions: New controllers, servers, client access SW upgrade for system components: new control SW version Application extension for new equipment introduced for extension Application change on some existing equipment

5 Project background PAS (Process Automation System) + BMS (Building Management System) End user: Richter Gedeon Biotechnológiai Üzem Automation Department Quality Management Department System supplier: ABB Mérnöki, Kereskedelmi és Szolgáltató Kft. Equipment suppliers Subcontractor teams: HW & SW plan, design, configure, test, commission All computer based systems must meet compliance requirements stated in Validation Plan, installation based on GMP & GAMP 5

6 GAMP 5 approach: computer systems Project & operation phases Same workflows to follow

7 Practices prior to project End user provides URS and VP approved (signed) documents PAS & BMS supplier quotes HW + SW + Services based on end user docs Services ca 50% engineering + 50% verification and documentation Equipment suppliers and end user provides Functional specifications Supplier to provide GAP analisys, then create PVP (Project and Verification Plan), then HW + SW Design specification and Test protocol documents Automation Department & QA approves the specifications and test protocols HW to build, HW and system SW to install and test SW applications to configure, program and test against approved test protocols Tests: Internal, dry, on site. CT (configuration) and FT (Functional) User acceptance tests to prove URS requirements meet

8 PROs and CONs of using docs PROs Commonly used tools exist (Word, Excel, Access, etc.) All teams and participants have experiences to use the tools No new investment for doc SW No training costs CONs Slow with high cost human effort to create, comment and sign docs Mix of paper and electronic issues Versioning is mostly manual Distribution of docs need extra tools No snapshot (baseline) capability Extra administration & project cost Manual traceability - if any Cost of create and store paper docs Approved paper docs are not searchable

9 Existing practice Common in most regulated sites in US and Europe Use well known documentation tools (Word, Excel) Staff is trained and forced controlled to follow the practices Effect of inspections: do what you did so far, or do it even better 30+ years traditions via continuous improvements an refinements Source: majapahit.net

10 What elephants can do? Source: Internet

11 How to start digital transformation? Source: Internet

12 Introduce digital transformation in automation project collaboration Prior the capacity extension Controsys Kft. and ABB Hungary decided to possibly implement a paperless PAS project GAMP5 template was developed in Application LifeCycle Management SW framework GAMP5 template covers 2 main parts of PAS lifecycle Project phase Operations phase Quoted a project including fully electronic collaboration, document and information management for Richter on a discounted price over traditional paper based documentation

13 Duties for ALM based solution provider ALM tool is a computer SW consequently has to be validated before use in real projects based on GAMP5 rules Personalized validation required for every end user ABB and Controsys created ALM requirement specification Functional requirements FDA 21 CFR Part 11 based requirements Test cases to verify all requirements ABB has executed the verifications and created qualification report ALM validation design and test cases prepared in ALM SW framework ALM core validation reported still on paper based documents!

14 ALM setup & use ABB Hungary set up and operates an ALM server Multiple ALM projects can be defined on the same server to support automation projects of ABB Hungary ABB Hungary provides licenses to its own staff and to the subcontractors working on different projects GAMP5 related workflows are defined by Controsys and continuously improved in the ALM framework High level, effective collaboration can be achieved with repeatable standards

15 Extend the ALM collaboration ABB Hungary plans to extend the methodology to foreign ABB operations System based templates and unified workflows will be provided to wider audience & user base Company operations can be standardized for project executions Online helps and trainings embedded in ALM tool itself can help penetration Possible ways of future ALM framework utilization 1. Centrally managed and administered for maintaining global control on operations 2. Template provided as is and let organizations adapt and customize locally

16 Target the end user ALM tool is a computer SW consequently has to be validated before use in real projects based on GAMP5 rules Personalized validation required for every end user Contract for project signed Real difficulties come later Organizations are usually not well prepared for electronic ALM End users has strong dedication to current practices (paper) Existing document store, versioning, but not accessible either for suppliers or System Integrators Even by having ABB QA validation report, new project has been introduced for the electronic ALM validation at end user

17 End user arguments SW based ALM expected to be fully specified based on existing practices There are generally differences in workflows for paper based and electronic ALM Default ALM SW solution not necessarily meet end user specific SOPs ALM SW has generic, configurable tools to adapt end user requirements End user with no experience may result step by step resolution to final ALM SW During the use of ALM SW changes are to be made based on better understanding of the user SOPs and based on practical experiences All above results multi-step iteration to hit the target

18 Comparision 1 Paper documents Work items / documents ALM SW Electronic (Word, Excel) docs Creation Independent single work items Manual, as attachment, (Document repository) Commenting, replying in documents + redistribute the documents Distribution Review No distrbution needed, web based instant access is available Comments, replies, Electronic signature (21 CFR Part 11) Manually sign papers Approval Electronic signature (21 CFR Part 11) Manually maintained in separate document Status Automatically maintained Manual Traceability Automatically available Paper based: n*(print+scan+ ) Alternatively Servide Desk / Ticket Change Standard workflow

19 Comparision 2 Paper documents Work items / documents ALM SW No Baselining Infinite number of baselines Manually set in documents Versioning Automatically keeps all versions Manual document store and numbering Manual on pre-printed test protocol document, printed evidences attached Manual GMP signatures on filled test report Replace paper or fix on paper and GMP sign History Testing Test approval Record changes Automatic, life cycle length Automatic or manual, evidences electronically attached (JPG, PNG, doc, pdf, etc.) Electronic signature (21 CFR Part 11) No (21 CFR Part 11). Modification of content is not possibe, or do by using Redefine in workflow Manually administered Test coverage Automatic dashboard

20 Comparision 3 Paper based ALM SW Traditional way (docs + paper) Electronically scan and store signed documents Change any workflow Backup / restore Electronic change, standard like other work items, historized Schedule automatic backups Immediate restore on new HW N/A Upgrade Generic IT level task after Risk Assessment done Ask QA person, probably full time job Ask QA person, probably full time job or rarely happens Administration Maintenance Generic IT level job Included in Admin job N/A Audit trail Automatic, built in, Login, change + access, etc. Manual Task schedule / release Included, traceable

21 Experiences Potential end users have far good IT environment and skills QA current practices hardly match available IT capabilities Generic fear of inspection and possible consequences, count on inspectors with traditional experience only Attitude to follow existing practices to avoid transitions and possible difficulties Some of the users do not simply believe anything can be done differently than they do it Some of the users do not simply believe this can be done by a SW based solution Generic opinion after an ALM SW demo seen: Absolutely nice and really looks good, but how could it handle our case?

22 Meet ALM SW first time

23 ALM SW initial acceptance

24 Achievements The SW based ALM is functional and active in the Biotech plant in Debrecen Same ALM server is utilized also in other projects of ABB Hungary even with different application template License number is constantly increasing as a result of gained experience and confidence among users No paper based validation document was prepared so far after the initial ALM validation has been completed!

25 ALM SW application includes Requirements of end user and regulatory requirements (GMP, GAMP) Functional and Design specifications for the System HW, SW and for the application development Reviews, approvals of all kinds of work items and configuration items using electronic signatures based on role based reponsibilities of end user FMEA Risk management, risk tasks, Observations and deviations (i.e. bugs), Change controls Test cases for all levels, test runs, test reporting and test report acceptance Tasks and time schedule for the whole project with timekeeping

26 Who can use ALM SW GAMP5 template? Regulated industries Prove compliance Use in case of inspection All industrial manufacturers and industrial plants using process control & automation Template also can be partially implemented or used Ensures proper collaboration and establishes a clear framework for all automation projects

27 Conclusions Confirm or deny? Elefant can be definitely trained to fly! Elefants fly differently than we generally think about flying!

28 Questions?

29 Thank you for your attention!