CGMP Consulting, Inc.

08/21/2026

Some projects are lasting memories because of what they let you give back. For Rachel Sitko, Senior Engineer, this is one of them.

One of Rachel's favorite projects was supporting a client through preparation for an FDA PAI. Working the back room during the audit offered a close, firsthand view an inspection is managed, the questions that are asked, the records that are requested, and how to interact to achieve the best possible outcome.

When a smaller client faced their own inspection, Rachel helped them get ready the way larger organizations do:
• Training to show the team what to expect during an inspection
• A full mock audit to expose potential gaps before an inspector does
• Practice answering questions and retrieving supporting records to simulate an inspection

The goal is to have a client who is prepared, confident, and ready for anything the inspection brings.

For those who have been through a PAI, what preparation made the biggest difference on inspection day?

08/20/2026

For Kate Aschoff, Chief Operating Officer, an early major facility expansion project became a lasting memory for not only the work, but also the people. During this multi-year project, she worked directly with as many as 45 new staff members and watched each round of hires grow stronger, then help train the next.

Some of our best leaders today got their start on that project.

Now, 25 years in, cGMP Consulting continues to grow in the same way: experienced people investing in the next group while delivering excellence to our clients.

What project shaped the way you lead today?

08/19/2026

Some projects give us long-lasting pride and fond memories. For Kevin Linde our CEO and founder, this is one of them.

This rewarding project was to help a pharmaceutical client meet the Drug Supply Chain Security Act (DSCSA) serialization requirements. The scope was one of our largest with hundreds of SKUs to convert from non-serialized to serialized versions across 12 packaging lines.

Serialization affects nearly every function in a plant. Getting it done meant coordinating:
▪️ Equipment upgrades with Plant Engineering
▪️ Qualification of those upgrades with Validation
▪️ Label updates with Packaging Engineering
▪️ SAP SKU updates with IT
▪️ Specification updates with Document Control
▪️ Scheduling with Materials Management
▪️ Recipe and configuration updates with Maintenance
▪️ New product introductions with Project Management
▪️ And reporting all of it to Plant Management

What Kevin loved was the work itself: partnering with stakeholders, solving problems as they surfaced, tracking SKUs to completion, and keeping the client informed at every step.

All SKUs converted on time, and many of them early; it was a memorable team accomplishment!

What was your most memorable, large-scale project?

08/18/2026

25 Years, 25 Stories

Who doesn’t love a great success story? 25 years as your engineering and compliance partner, this milestone deserves some extra celebration.

So, we asked staff and clients to share their favorite memories. Over the coming weeks, we will share 25 stories about favorite projects, lessons learned, or personal growth.

We hope these reflections give you a little more insight into who we are.

Stay tuned for the first installment tomorrow!

08/17/2026

Happy Birthday to our CEO, Kevin Linde!

Kevin brings the same positivity, grit, and heart to leading his family up the mountain as he does to leading our team.

Please help us wish Kevin a wonderful year ahead!

08/12/2026

Testing a vendor-supplied feature as hard as your custom, high-risk code takes time and doesn’t show you fully understand system risks.

This is the focus of GAMP 5 and the FDA draft guidance on Computer Software Assurance (CSA).

Full overview: https://cgmpconsulting.com/computer-system-validation-csv-a-risk-based-guide/

08/11/2026

An interim position is judged by its status at its completion.

Done well, the handoff is the point. The organization does not simply return to where it stood before the vacancy. It moves forward from a stronger position.

That is the difference between covering a role and strengthening a quality system.

Reach out at https://cgmpconsulting.com/contact-us/ to learn how we can help your organization.

08/07/2026

Proud to Support Literacy and Learning Across Chicagoland!

Some of our staff volunteered at Bernie's Book Bank this week, sorting and quality-checking children's books for distribution to children in our area.

It's always rewarding to give back and make a positive impact in our community. Thank you to everyone who participated!

08/05/2026

What are your options when a leadership role is emerging or sitting empty?

Our new article walks through interim and fractional leadership in FDA-regulated operations, with practical considerations for both small organizations growing into an emerging quality role and established organizations covering a vacancy.

👇 Give it a read.

A practical, risk-based guide to Computer System Validation (CSV) for FDA-regulated companies, covering GAMP 5, CSA, the V-model, and data integrity.

08/04/2026

An open role does not have to mean lost ground.

Interim quality leadership is often assumed that the status quo with be maintained.

This is where our experience can move your organization forward. A leader who has been through transitions before does not wait for the permanent role to be filled in order to move priorities forward.

The work does not have to wait. If we see opportunities, we will drive them forward.