Process Centralization and Automation Proves Invaluable for ISO Audit

How Omnify Empower helped Cytonome Inc. create a centralized, automated development infrastructure through product lifecycle management

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Most animal and plant tissues contain a mixture of cell types. However, there is a growing interest in studying a pure population of one type of cell. In some cases, cells differ in some physical property that allows different cell types to be separated. White blood cells (leukocytes) and red blood cells (erythrocytes), for instance, have very different densities because erythrocytes have no nucleus; thus these cells can be separated on the basis of density. Since most cell types cannot be differentiated so easily, other cell-separation techniques have had to be developed. Boston-based Cytonome was founded on the premise of providing advanced solutions for these cell purification needs.

Cell Purification Technology
Cytonome produces advanced, high quality cell purification systems for bio-medicine, bio-industry, and bio-science. The company developed an innovative and proprietary technology that combines with optical detection to achieve the precise and safe selection of discrete cell subpopulations. Their bio-medicine products target a cGMP-compliant cell purification using a closed, sterile and disposable cartridge to guarantee operator safety and sample isolation.

Silos of Automation and Manual Operations
Cytonome’s engineering department aims to quickly develop new product innovations. There is a collaboration that takes place in which engineering deliverers concepts to manufacturing and manufacturing then works with them in tandem during prototyping. This is why it was so important to achieve bi-directional seamless communications among engineering, manufacturing and purchasing. It was quickly determined that only a product development environment that would support centralized and automated processes would be effective for the kinds of products Cytonome develops.

Unfortunately the tools the company were using did not interface or communicate well with each other, creating small silos of data that was coming from such systems as SolidWorks Workgroup PDM, CAMA Software QCBD (Quality Collaboration by Design), and Expandable ERP, to name a few. Product information was transferred from SolidWorks into Excel spreadsheets. Due to information having to be manually entered into each individual system, Cytonome was discovering that their systems contained incorrect or out-of-date information. Valuable employee time was being wasted introducing human data-entry errors that could prove costly.

“The process was rather burdensome and error prone,” stated John Bragg, Mechanical CAD Designer for Cytonome. “We quickly understood that what we needed was a solution that could automate engineering change order workflows, ensure all steps were being followed, and deliver a one stop location for all of our documentation needs.”

Cytonome also needed to ensure it would be able to meet ISO Standards, which ensures that all products are safe, reliable and of good quality. For this, they needed to put in place formal procedures to manage, track and report their product development and manufacturing operations.

Creating One Single Cohesive Environment
In creating a seamless unified infrastructure, the first matter at hand was to address Cytonome’s manual product development processes. The criteria they needed involved a solution that delivered a centralized location to manage product information and quality processes. The solution also needed to integrate with SolidWorks and Expandable ERP, which would then eliminate manual data entry. Leveraging certain employees’ previous expertise in Product Lifecycle Management (PLM) technology and Omnify Software, Cytonome investigated potentially using Omnify’s Empower PLM solution. “After seeing a customer demo, we were impressed with the capabilities and simple web interface of Empower,” noted Mr. Bragg.

Cytonome selected Empower PLM because it allowed them to create automated signoff workflows for new Part Requests (NPRs) and Engineering Change Orders (ECOs) as well as establish automated data transfer with SolidWorks and Expandable with ease. The Omnify Empower Quality Management and Training Management modules support their ISO compliance and ability to achieve full cGMP compliance. All Non-Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), process deviations and customer service repair processes are managed within the Quality module and directly connected to the product record in Omnify Empower. The Training Management module manages and tracks employee training documentation, calibration processes and calibration records. Omnify tracks, manages and controls business documents such as product engineering reports and Non-Disclosure Agreements (NDAs).

PLM Deployed Enterprise-Wide
Omnify Empower delivers a central location to securely access accurate product data and documentation for practically the entire company. “Over eighty five percent of the company uses Omnify Empower at Cytonome including engineering, quality, manufacturing and purchasing,” stated Heather Kiessling, Chief Financial Officer for Cytonome. “The most significant business benefit of using Omnify Empower is the real-time global updates among engineering, purchasing and manufacturing that we did not have before.”

Quality information is now shared in real-time across the organization. When an ECO is under review, engineering, purchasing and production know this information immediately. Decisions on buying parts or build plans for assemblies under ECO are made in real-time. Purchasing can access the system to pull the most up-to-date drawings that need to go to vendors for fabricated parts. Manufacturing has access to the most accurate and current BOM with automated updates from Omnify Empower to Expandable ERP. “Our overall product development processes are faster and more efficient due to the time savings and improved data accuracy we have realized by implementing Omnify Empower as our central product information management system,” said Miss Kiessling.


ISO Audit Gets a Thumbs Up
Due to Cytonome’s new centralized and automated product development processes, auditors saw that they had the proper signoff, history tracking and reporting to meet ISO compliance guidelines. During their first ISO audit, the auditor positively remarked how everything was in order when reviewing Cytonome’s tracking and management of calibration records, training on quality documents, and procedures associated to groups.

The auditor noted that he was very impressed with the capabilities of Omnify Software and the extent to which Cytonome uses it to control information, documents, changes, training, project data, manufacturing processes and engineering data and was particularly pleased with Cytonome’s automated workflows and signoff stages with history tracking for NCMRs and ECOs.

“The success of our preparation for our first ISO audit as demonstrated by having the first two days with no findings is a direct result of having (and using) Omnify Software,” commented Miss Kiessling. Adopting Omnify Empower validates Cytonome’s commitment to manufacture their products under the strictest quality control guidelines and deliver the most advanced, high quality cell purification systems to the market.

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