About ComplianTech
ComplianTech is a founder-led firm built on years of hands-on work inside regulated biotech laboratories and manufacturing. We help companies find and close data integrity gaps, using the same methods we developed and relied on in our own careers.
ComplianTech is a new company. The experience described on this page comes from our founders’ past careers, and employer names are never listed.
Dave Zimmerman
Cofounder, Systems and Technology
Laboratory systems
LabX, UNICORN, Chromeleon, SeqStudio, HPLC and UHPLC, spectrometers, balances, moisture analyzers, refractometers, porosimeters, titrators
Facilities and equipment
Building management systems, cold storage, incubators
Enterprise integration
ERP, electronic document management, Active Directory, Workday
Development
.NET, Entity Framework, SQL Server, Docker, Azure, SharePoint, Power Automate
I’ve spent my career inside biotech companies, building the systems that laboratories and manufacturing teams depend on and making sure those systems hold up to regulatory scrutiny.
Technical support in biotech
I started in tier 3 technical support at a biotech manufacturer, where I spent 5 years learning how scientific and manufacturing operations actually run.
Independent systems development
I then started an independent practice and spent 8 years building custom systems for that company. They included a training management system that tracked SOP reading, barcoded on-the-job training forms, classroom sessions and external online courses, and a shipping system integrated with the company’s ERP that produced commercial invoices, dangerous goods declarations and bills of lading.
I also built a right-first-time tracking system for batch record corrections, and a reporting system that combined ERP work orders, Active Directory, Workday and equipment utilization data to measure schedule attainment across manufacturing, QC and QA release.
QC Systems Engineer
I then joined a different biotech company as a QC Systems Engineer and worked there for five years. The company was preparing for its products to be regulated as medical devices, and its regulated customers already expected it to operate that way.
We built a second laboratory that had to match the existing manufacturing facility exactly, and I was the data integrity expert on the team that set up and validated it, from the building management system and cold storage to every scientific instrument in the lab.
We performed a data integrity assessment on every instrument. Early on, we found that the corporate assessment method wasn’t strict or specific enough to rely on, so we rebuilt it. That experience shapes how we run assessments at ComplianTech today.
I also built a system for tracking equipment downtime, user-reported issues, spare parts and preventive maintenance, using tools the company already had: SQL Server, SharePoint, Microsoft Lists and Power Automate.
ComplianTech
What colleagues relied on me for wasn’t any particular technology. I have a near-obsessive need to understand rules and follow them exactly, which is why people from other departments regularly brought me into risk assessments and audits.
It’s also why I started ComplianTech with my cofounder: to bring that same discipline to companies that need it.
Val Zimmerman
Cofounder, Quality and Compliance
Laboratory scope
Raw material inspection and approval, in-process and release testing, stability testing, second-source validation support
Quality systems
OOS and OOT investigations, deviations and CAPA, change control, method transfer and validation support, training
Audits
Hosting the QC laboratory in customer audits and responding to findings
I’ve spent 19 years with a biotech manufacturer, starting in manufacturing and spending the last 14 in quality control, where I now supervise the team that tests and approves the materials and products the company depends on.
Manufacturing
I started out packaging finished goods in manufacturing, then ran the manufacturing laboratory on my own as its main technician for about four years. That gave me a firsthand understanding of how production works and what it needs from the lab.
Quality control
I moved into quality control as a QC technician and became QC Supervisor in 2021. Since then I’ve led teams ranging from 4 to 19 people, and I currently lead a team of seven. We inspect and approve all incoming raw materials, support in-process and release testing for manufacturing, and support other laboratories with second-source validations and stability testing. I review and approve my team’s data before it’s used.
I’ve handled out-of-specification and out-of-trend investigations, deviations and CAPAs, and change control, and I’ve supported method transfers and validations and put training programs into practice in the lab.
Customer audits
I represent the QC laboratory in every customer audit: walking auditors through the lab, explaining how it operates, answering their questions, and responding to their findings, including the CAPAs that follow.
ComplianTech
Dave and I started ComplianTech as a team. He brings deep systems expertise, and I bring the perspective of someone who reviews data, investigates problems and faces auditors every day. When Dave assesses a client’s systems, I evaluate the processes behind them and identify the gaps the client needs to address. I also review every proposed solution before it’s put forward, to make sure it will work for the people who have to follow it.
How we work
You work directly with a founder from the first call to the final readout. There are no handoffs to junior staff and no account managers between you and the work.
Every finding and recommendation is reviewed from both a quality management and a systems perspective before it reaches you, so what we propose is sound on paper and practical to put in place.
We prefer to strengthen the systems you already have before recommending anything new, and we keep validation effort proportionate to risk.
Let’s talk about your systems.
A short scoping call is enough to understand where you are and whether an assessment makes sense.