WHAT IS ORCANOS WORKSHOP
Orcanos workshop for new customers is an educational program, usually takes 2-3 days in each session, and conducted in customer facilities.
It is designed to teach or introduce to participants practical skills, techniques, or ideas which they can then use in their work with Orcanos products, and is suitable for small and medium size companies, where Orcanos socializes in the medical device development and quality management.
Orcanos have extensive and successful experience to meet your goals and have you up and running by the end of the workshop, with a complete ALM (Design Control) and Quality Management System that ties it all together.
Orcanos main expertise is in the medical device industry, and usually, we assist in compliance to ISO 14971, IEC 62304 and ISO 13485
Below is an example of a basic agenda for Orcanos workshop:
- Day 1: Organization analysis, data import analysis
- Day 2: Risk, Requirements and test management
- Day 3: Document Control, Admin, reports
WHY TAKING ORCANOS WORKSHOP
Orcanos workshop provides a way to create an intensive educational experience in a short amount of time, when the time for a more comprehensive effort may not be available. Participants may be working, they may be too far apart to gather together regularly, or may simply be unwilling to commit large amounts of time. A workshop can introduce a new concept, spurring participants to investigate it further on their own, or can demonstrate and encourage the practice of actual methods.
It’s a great way to teach hands-on skills on Orcanos system because it offers participants a chance to try out new methods and fail in a safe situation. Failure is often the best teacher, and failure in this instance doesn’t carry a cost. At the same time, feedback, from both the presenter and peers in the group, helps a participant understand what they can do to avoid failure in the future.
SETTING THE GOALS
Setting goals is an excellent way to provide you with direction and purpose. The more you can clearly define your goals, the more likely you are to achieve success. Goals can help you to channel your energy towards meaningful activities as you go along. The purpose of this Goal Setting Workshop is to help you accomplish your goals through an organized process made easy for you.
TOOLS
Master project plan: Every workshop has a master project plan supplied by Orcanos, helping the customer understand workshop scope and add topics required (Usually shareable Google Sheet).
Session recording: We use video capturing tools (such as Snagit) in order to record the sessions, which are customer propriety for future reference.
Data migration: Use Orcanos professional team in order to import all required information into Orcanos repository
BEFORE WE START
| Start | After Quotation Approval |
| Goal | Setup and prepare system for use, prepare workshop and understand required migrations and integrations |
| Customer actions | – Complete customer questionnaire
– Workshop preparation: attendees, location |
| Orcanos actions | Configure system, provide (cloud) environment, configure users, etc. |
| Deliverables | – Customer questionnaire
– Orcanos customer environment with configured users – Workshop scheduled, agenda is set |
| Duration | 1-3 weeks, depend on company readiness |
WORKSOP
| Start | After preparation, based on schedule |
| Goal | Upon completion of the workshop, the system is ready for use. This means:
– Main processes analysed and configured – Core-users trained |
| Customer preperations | – Meeting room
– Beamer – Whiteboard – Coffee/drinks/lunch – PCs/laptops for attendees |
| Orcanos actions | Prepare training, based upon questionnaire, customer wishes and attendees |
| Deliverables | – Workshop completed
– System ready to use |
| Duration | Usually 3-4 days, for ALM and QMS, 2-3 days for ALM/QMS only |
WORKSHOP AGENDA
| Task | Day | Remarks |
| Meet the team | 1 | |
| Company Introduction | ||
| Initial presentation | ||
| Define Workshop scope | ||
| Organization structure | ||
| Product Architecture Review | ||
| Analyze current processes (requirements, testing, risk…) | ||
| Configure Product hierarchy | ||
| Build Projects/Components and Versions | ||
| Documents and reports Review | ||
| Discuss Migrations/integrations | ||
| Documents Migration (partial) | 1,2 | |
| High/low level requirements | ||
| Risk Management | ||
| Forms Configurations | ||
| Status flows, e-sign | ||
| Defining reports, and traceability, building dashboards, impact analysis | ||
| Analyze and configure SQA, test design, test execution, reports | 2,3 | |
| e-DMS | 3 | |
| e-Forms and quality processes: CAPA, ECO… | ||
| Regulations, compliance and quality | ||
| Admin | ||
| Service Center – Complaint Management | ||
| DMS Alerts | ||
| Hands-on Training |