2017 Omnify Software User Conference

September 19-21, 2017, Scottsdale Plaza Resort   

Main Content


Breakout sessions provide an optimal learning environment by allowing you to participate in small, focused workshops to better meet your specific training needs. There are sessions to meet all user levels.

Session attendees will gain a better understanding of key functions to make their job easier as well as take away valuable material to share with colleagues and facilitate the application of what was learned within their own Omnify Empower environment.

Sessions are broken out into tracks based on their content focus. See below for the current keynote presentations and sessions.


Presented by: Chuck Cimalore, CTO, Omnify Software.


Presented by: Markus Harmaavirta, PLM concept owner and technical lead, Nokia Tech, Consultant, Purmaconsulting Oy

This presentation will walk you through how Nokia Tech handles design collaboration with their external design partner in different phases of the product lifecycle using Omnify Empower PLM. This session will cover what information is stored, how different stages are approved, and how the process evolves after the first official release of the product.

Presented by: Cara Wong, Manager, QA Document Control and Records Management, Abbott MCS Business Site (formerly SJM/Thoratec)

This session will help attendees to better define the lifecycle of an Item. Topics covered will include:
  • How are requirements defined and made consistent per lifecycle
  • How Change Control (Reviewers and Approvers) is defined and tracked for adequate check/balance per lifecycle requirements
  • How to consistently process each change order according to lifecycles (so that Project Management teams have a better idea what timelines to plug into their planning)

Presented by: Rinda Sama, VP of Operations and Quality, Axonics Modulation Technologies

Axonics Modulation Technologies is a medical device company developing an innovative neuromodulation platform based on miniaturized rechargeable technology. They currently utilize the Omnify Empower Document Control, Supplier Management, Training Management, Equipment Management, and Bill of Material (BOM) management modules. The company has also configured Omnify to address areas such as: material citations (used to accelerate biocompatibility risk analysis and answer other regulatory queries), calibration and preventive maintenance, component characteristics such as electrical part footprints, supplier part number decoders, and Design History File (DHF) auto-generation.

Learn how they configure Omnify to address these common company challenges.

Presented by: Omnify Software on Behalf of BionX Medical Technologies

Attend this session to learn how BionX leveraged Omnify Empower to manage data for their ISO re-certification that resulted in zero non-conformances.


Presented by: Penny Goss, Owner, Goss Technical Solutions

This session will provide answers to the most commonly asked questions about software documentation and validation including: why documentation is important, what documentation is required for regulatory validation, what is the difference between validation of an onsite instance of Omnify compared to a hosted instance, how to upgrade a validated system, and how Penny sees validation regulations changing in the future.

Presented by: Scott Schaffer, Configuration Management, Leonardo DRS, Tools and Processes

Working with all the pieces of the Omnify Administrator can be overwhelming. This presentation explains how Types and Categories work with Stages, Attributes and Roles/Groups to create effective workflows. It also explains how required fields and defaults help to gather and pass information throughout your organization.

Presented by: Alexander Bugaev, Senior Applications Engineer, and Jukka Kivari, HWM/EDA Manager, Nokia Tech

This session will provide an overview of the IT architecture of the Omnify Empower system in the Cloud and will walk attendees through how the system was built at Nokia Tech. It will illustrate a high level design of the system and the main points of system administration and security. The main challenges and lessons learned from deploying Omnify Empower in the cloud will be highlighted as well.


Presented by: Cyndi Kuka, Sr. Document Control Specialist, MRV Communications

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. The challenge with REACH is that the number of substances is updated every six months. In addition, MRV must audit their supply chains and report use of conflict minerals to comply with the Dodd-Frank Consumer Protection Act. Suppliers must report on Form CMRT (Conflict Minerals Reporting Template version 4.01 or higher) and are audited on a yearly basis.

In this session you will learn how Cyndi Kuka at MRV Communications has created a simplified way to handle REACH and Conflict Minerals compliance challenges by using Vendor Part Numbers, Attributes, Documents, and ECOs.

Presented by: Carla Sivak, VP of Quality and Regulatory, Portal Instruments

Portal Instruments is a 13485 Certified Medical Device Startup using Omnify for Doc Control, Vendor, Equipment, Training and Quality. This session will focus on the Quality module which Portal uses for CAPA, Audits, Quality Plans, Temporary Deviations, Nonconforming Reports, Employee files and extensions. Attendees will learn how Portal associates related documents to demonstrate completion of corrective actions and has the ability to search these items rather than generate a paper report.

Presented by: Eric Krosky, EDA/Tools Engineer, Acacia Communications

Attend this session to learn how easy it is to calculate assembly level FIT (Failure In Time) Rate from part attribute data and the standard Cost Rollup Report.

Presented by: Rasean Hamilton, Director, Quality Systems, EarLeans

Attend this session to learn how EarLens created an extensive, validated complaint handling process with Empower PLM.


The conference networking sessions are designed to provide a structured, round-table environment to network with your colleagues with whom you have common interests. These sessions provide another opportunity to develop your knowledge, gather new perspectives, learn new methods, and to meet colleagues.

Come to these sessions prepared with a list of questions to ask your peers and to share your experience to help someone else. A moderator is present to keep the discussion centered and to highlight topical issues. The networking session topics have been determined by customer feedback. If you would like to add a topic for a networking session, please notify us.


Get answers to your specific product questions. The Tech Lab provides the opportunity for customers to meet one-on-one with Omnify Technical Staff for 30-minute sessions. The Tech Lab will not be open during conference keynote or breakout sessions.

Registration is Closed. Email ouc@omnifysoft.com