PRESENTATION Digital transformation in practice, i.e. how to teach elephant to fly? Keresztesi Kálmán Controsys Irányítástechnikai Kft . kalman.keresztesi@controsys.hu 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
Agenda • Project background • Current practices • Digital transformation in automation project collaboration • Digital transformation in quality management • Human factors of the transformation process • Experiences • Conclusion 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
Source: Wikimedia by Srilekha selva Cross-wiki upload from en.wikipedia.org 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
The project • Location: Richter Gedeon Biotechnology Plant, Debrecen • In operation: 2013- • 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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
GAMP 5 approach: computer systems • Project & operation phases • Same workflows to follow 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
PROs and CONs of using docs PROs CONs • Commonly used tools exist • Slow with high cost human effort to create, comment and sign docs • (Word, Excel, Access, etc.) • Mix of paper and electronic issues • All teams and participants have experiences to use the tools • Versioning is mostly manual • No new investment for doc SW • Distribution of docs need extra tools • No training costs • 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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
What elephants can do? Source: Internet 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
How to start digital transformation? Source: Internet 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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! 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
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 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
Comparision 1 Paper documents Work items ALM SW / documents Electronic (Word, Excel) docs Creation Independent single work items Manual, as email attachment, Distribution No distrbution needed, web (Document repository) based instant access is available Commenting, replying in Review Comments, replies, documents + redistribute the Electronic signature documents (21 CFR Part 11) Manually sign papers Approval Electronic signature (21 CFR Part 11) Manually maintained in separate Status Automatically maintained document Manual Traceability Automatically available Paper based: n*(print+scan+email) Change Standard workflow Alternatively Servide Desk / Ticket 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
Comparision 2 Paper documents Work items / ALM SW documents No Baselining Infinite number of baselines Manually set in documents Versioning Automatically keeps all versions Manual document store and History Automatic, life cycle length numbering Manual on pre-printed test Testing Automatic or manual, evidences protocol document, printed electronically attached (JPG, PNG, evidences attached doc, pdf, etc.) Manual GMP signatures on Test approval Electronic signature filled test report (21 CFR Part 11) Replace paper or fix on paper Record changes No (21 CFR Part 11). Modification and GMP sign of content is not possibe, or do by using „ Redefine ” in workflow Manually administered Test coverage Automatic dashboard 24-26 October 2018 Miskolc- Lillafüred, Hotel Palota****
Recommend
More recommend
