Hunting for Better Traceability Audit and CAPA Management

Transcription

1 Hunting for Better Traceability Audit and CAPA Management Veijo Inkiläinen

2 Veijo Inkiläinen M.Sc. IT Process Development Manager, Software - Planmeca Oy Quality system and software process development History Software Design Manager Planmeca Oy Dental care unit products software design and software process development Engineering Manager GE Healthcare Finland Oy Software Manager GE Healthcare Finland Oy Mammography imaging Project Manager Instrumentarium Oy Imaging-division Mammography imaging Software Consultant/CEO Vegeli Oy Dental Imaging and mammography imaging products Project and program manager Datex-Ohmeda Anestesia information management systems

3 Planmeca Group Founded 1971 in Helsinki, Finland Now the largest privately owned dental manufacturing company in the world One of the world s largest providers of dental equipment and growing

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5 Fighting breast cancer with advanced technology A trusted leader in mammography imaging solutions

6 Made in Finland Everything is designed, built and assembled under one roof for an unmatched attention to detail + Built using the latest technology and the best materials + Developed with the strictest quality control standards In total m 2 floor space

7 Case: Audit and CAPA management How to automate paperbased AUDIT - and CAPA (corrective and preventive actions) - management system

8 Regulatory Background ISO13485 Certified Quality Management System Internal and external audits Corrective and preventive actions

9 IT Background Product change management Complaint File CAPA Audit Records Risk Management Document management

10 Audit Management Before Internal audit records managed with paper documents Time consuming Hard to track completion of deviations External audit records managed with documents provided by auditors Time consuming to manage and update different types of audit records Hard to track completion of deviations SOMETHING NEEDS TO BE DONE!

11 CAPA Management Before CAPA = Corrective and Preventive Actions CAPA management scattered to organization Hard to track status of CAPA actions Burden of whole workload of audit and CAPA process rested on quality department SOMETHING NEEDS TO BE DONE!

12 Tool Hunting Tool candidates Master Control Trackwise NextDocs Polarion Main drivers to select Polarion Cost-effective Possibility to be validated as electronic database with electronic signatures (FDA Part 11) Full traceability Full application (product) development life cycle support including software development with Agile

13 Deployment of Polarion Development of process features done in-house Additional plugin developed by Taipuva Consulting to implement extended notifications Reminding of due tasks on configurable intervals before due date Escalation of undone tasks to configurable manager level Iterative development and training cycle with users

14 Audit Records Database

15 Audit Records Requirements Internal and external audits and corresponding nonconformities stored Digital approvals Simulates paper-based form partially Tracks audits as workitems Tracks nonconformities as workitems Deadline reminders by Escalation of not completed nonconformities by notification Audit reports Access restrictions (contains confidential and sensitive information)

16 CAPA Records Database

17 CAPA Records Requirements CAPA records from various sources stored Digital approvals Tracks CAPA issues as workitems Tracks CAPA corrective and preventive actions as workitems Deadline reminders by Escalation of not completed actions by notification CAPA reports CAPA trending

18 Pros & Cons of Using Polarion + End-to-end traceability Cost-effective solution Processes easy to modify Extensive API provides tools to extend functionality and migrate information from other systems Operation of basic elements is unified. User can use any application in the tool, when learns to use one Polarion support is working well Local partner available (Taipuva Consulting Oy) - Entry form layout and functionality configuration should be more enhanced Basic out-of-the-box workflow in Polarion needs to be scripted to automate some tasks that could be configuration options in the tool itself Integrated workflow visualizer missing

19 Lessons Learned - Involve users early to development of new Polarion processes to get commitment and feedback - Plan document format and location - As LiveDocs in Polarion - As document files in Polarion version control (SVN) - As documents outside Polarion - Plan linking to design items and documents outside Polarion - Hyperlinks - Version control revision links (SVN or GIT) - Use small pilot projects first - Plan phasing of importing data to Polarion from other systems

20 Benefits in the Future Big savings in work amount, when traceability can be automated instead of maintaining traceability matrixes manually Savings in tool deployment work, when no local installations are needed Centralized repository of information helps in maintenance of data Audit trail helps to see, who did what Data visibility across organizations. Management has realtime visibility to (agile) software development team work. Software developer has realtime visibility to business and user requirements. Possibility to restrict sensitive and confidential data visibility by access rights Version control system Subversion ready to use as it is validated as a tool together with Polarion

21 Vision Polarion Audit Records Complaint File CAPA Product change management Risk Management Software Development Document management

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