Process Stream

In April 2021, Process Stream was acquired by Sikich LLP to bring new expertise and solutions servicing digital transformation clients in regulated industries, which includes life sciences. The acquisition expands Sikich’s offerings into quality management and IT compliance, enabling the firm to help companies as they journey from early stages through commercialization.

Big4Bio Editor Marie Daghlian recently spoke with Mike Kean, partner and head of Sikich’s ERP and CRM practices, and Bobby Roy, former CEO of Process Stream and Sikich partner now in charge of regulatory quality and compliance, to discuss how Sikich's new practice is thriving with expanded capabilities and organizational support.

Check it out here!

Sikich + Process Stream = Expanded Best of Breed Solutions Through a Company’s Journey - BIG4BIO Sikich LLP is a 1000-member business advisory firm that offers ERP and CRM technology and accounting services to a broad array of companies, including life sciences, tailored to fit their specific needs. In April 2021, Sikich acquired Process Stream, a leader in digital transformation services for r...

The FDA eMDR eSubmission Gateway and the EU MIR forms have been reflecting new changes to fields and structures to harmonize codes on IMDRF code sets.

With this harmonization, it is now possible to align and harmonize your post-market surveillance process, using the IMDRF unified coding system from the Complaint record to the individual reports to the FDA and European Competent Authorities, ensuring data integrity in your system, and supporting trend and similar incident analysis.

If your organization is struggling with compliance implementations before the next mandatory deadline (November 30, 2021) let our Sikich LLP (Formerly Process Stream), eQMS experts, design a plan to optimize business processes while meeting the necessary regulatory requirements.

Schedule a call today via the calendar link below!
https://bit.ly/2VAk42o

Is your organization being served jurisdictional penalties due to non-compliance? Has your team’s limited bandwidth or lack of subject matter expertise led to recurring violations?

Sikich LLP (Formerly Process Stream) can streamline efforts for regulatory reporting obligations today by configuring your platform to eliminate inconsistencies and correct oversights. Our consultants will help you build a clear roadmap to sustain compliance for today’s evolving requirements. We’ll tailor a plan to supplement your staff and bring critical expertise to help:

• Identify problem areas with a thorough assessment
• Lift the burden of managing historical claims
• Support and drive jurisdictional correspondence, and file corrective action measures
• Translate business needs for your technology stack
• Fine-tune your platform to its true potential (add prescreen automation, drop-downs, autofill functionality)

Set up a discovery call with our team today to learn how we can help!
https://bit.ly/2TfhVsd

Sikich LLP (formerly Process Stream) is proud to be a 2021 Gold Sponsor of Insurity Summit and a Preferred Systems Integrator of Insurity.

Make sure to join us for our sponsored session (Purpose-Built Solutions for a Simplified MGA Experience) featuring key insights and perspectives from Insurity's senior leaders!

https://bit.ly/2SvR7Up

They’ll cover current market approach, dig into synergies between data/analytics and straight-through-processing, as well as strategies to help manage risk.

Also, be sure to stop by our virtual booth in the conference showroom after the session to meet our team, and fill out our brief survey for a chance to win a year of Amazon Audible (online audiobook & podcast service) on us!

https://bit.ly/3gJqB1U

Per the latest guidelines recommended by the FDA, how is your organization managing Computer Software Assurance (CSA) for manufacturing, operations, and quality system software? Is your team facing challenges to implement those standards?

Let our IT Quality & Compliance experts execute a plan that applies a risk-based approach, leverages vendor testing and automation, and shifts focus to assurance (not validation).

Set up a discovery call with our team today to find out how we can help reduce your regulatory burden!
https://bit.ly/3pEMvXS

We’re a little under two weeks away from Insurity Summit 2021!

The featured speakers and deep-dive sessions at this complimentary virtual event (June 15th, 17th and 22nd) are sure to be informative and will provide a great opportunity to network with industry leaders.

As 2021 Conference Gold Sponsors and Preferred Systems Integrators of Insurity, we hope you’ll stop by the Sikich LLP (Formerly Process Stream) virtual booth to meet our experts. Be sure to enter our giveaway for the chance to win some exciting prizes!

Stay tuned to this page for updates/prize reveals, and drop us a line today to secure a one-on-one discovery session with our team. (before they fill up!)
https://bit.ly/3vSGCbX

If you haven’t yet, register today!
https://bit.ly/3fOwrj5

Is your organization looking to supplement application support and business process expertise for your transition to digital?

TrackWise Digital® Managed Service plans by Sikich LLP offer flexible agreements to execute your short-term, tactical priorities, while also fostering internal growth and development for your team's long-term success.

We'll help identify critical gaps and customize a plan for our QMS experts to mentor/guide your resources through the implementation with any combination of services:

- Ticketing & troubleshooting
- Maintenance activities (adding fields, dependencies, object management)
- Ongoing support updates to Process Builders
- Enhancements (Workflow configuration)
- Migration assistance
- Regression testing (Salesforce platform upgrades)
- Builds for analytics & reporting

To learn more, click the calendar link below and schedule a discovery session!
https://bit.ly/3fLIOfF

We're proud to be the Gold Sponsor of Insurity’s 2021 Virtual Summit!

As preferred systems Integrators of Insurity we’re excited to share insights and perspectives with the insurtech/claims industry’s best and brightest.
https://bwnews.pr/34mQuP2

Hope to see you there. If you haven’t yet, register today!
https://bit.ly/3ujP3eU

*Process Stream has joined Sikich LLP. Click below to learn about our expanded capabilities.
https://bit.ly/3fp5gem

Can your QMS data be trusted?

With the increasing complexities of IT systems and evolving regulations in Biopharmaceutical and Pharmaceutical manufacturing processes, managing QMS Data Integrity risk is a vital initiative.

Our Compliance as a Service (CaaS) plans are built to adapt your compliance strategies, add versatility, and help mitigate looming risks.

To set up a discovery session with our Regulatory Compliance Consultants, click the link below and choose the date/time that works best for you!

https://bit.ly/3urz2U2

*Process Stream has joined Sikich LLP. Click below to learn about our expanded capabilities.
https://bit.ly/3frvuNE

Has your organization been struggling with post-go-live maintenance and enhancements for your ClaimsXPress ecosystem? Our insurtech/P&C business process consultants and technologists have been helping clients manage configuration updates, business rules, integrations, and have even supplemented internal training resources in strategizing/executing today's industry best practices.

Sikich Managed Service Support programs provide expert-level service tailored to your team's needs. Our extensive domain knowledge and experience ensure you are keeping pace with evolving compliance requirements while getting the most out of your ClaimsXPress investment.

If your team is looking to bolster support and streamline your claims administration platform, we'd love to chat. Set up a discovery session with our experts via the link below.

https://bit.ly/3f4TYfp

Proud to be Preferred Systems Integrators of Insurity!
https://bwnews.pr/3y7oVqD

If your organization is looking to advance capabilities for your ClaimsXPress ecosystem, set up a discovery call with our P&C experts today!
https://bit.ly/3y7oVXF

For more information about us joining Sikich LLP and our expanded capabilities, give us a follow on the official Sikich social channels!
https://bit.ly/3y7oWeb

Check out the official announcement!

https://bit.ly/3dIHPdW

Sikich expands digital transformation services with acquisition of quality management and insurtech consultancy - Sikich LLP Sikich will acquire the assets of Process Stream, a leader in digital transformation services for regulated industries, including life sciences and insurance. Process Stream specializes in quality management, IT compliance, and insurtech systems implementations and consulting.