Experience

CS-01Founder experience

Validated QC laboratory for a biotech manufacturer preparing for regulation

Setting

Biotech manufacturer anticipating medical device regulation, supplying regulated customers

Role

Data integrity expert, QC systems team

Systems

Building management, cold storage, incubators, balances, refractometers, titrators (LabX), HPLC, FPLC (UNICORN), UHPLC (Chromeleon), spectrometers, genetic analyzers (SeqStudio)

Challenge

A second laboratory had to match the capabilities of the existing manufacturing facility exactly, and operate to regulated expectations from its first day, ahead of anticipated regulation and in line with what regulated customers already required.

What we did

Set up and validated the laboratory’s facility systems and every scientific instrument. Each system was assessed for data integrity before use and configured to address what the assessment found.

Outcome

The laboratory began operation with every system assessed, configured and validated, and with documentation showing how each one was controlled.

CS-02Founder experience

Rebuilding an instrument data integrity assessment method

Setting

The same laboratory program as CS-01

Role

Data integrity expert

Scope

Every scientific instrument and facility system in the laboratory

Challenge

The company’s existing method for assessing instrument data integrity was too general and not strict enough to support conclusions that would hold up to customer or regulatory scrutiny.

What we did

Rebuilt the assessment process with specific, defined checkpoints and stricter criteria, then applied it consistently to every instrument and system in the laboratory.

Outcome

A repeatable assessment method that produced consistent, defensible results. It became the foundation of the ComplianTech Data Integrity Assessment.

CS-03Founder experience

Training management integrated with document management

Setting

Biotech manufacturer

Role

Independent developer

Integrations

Electronic document management, external training platforms via REST APIs

Challenge

Training came from several sources: SOP reading, on-the-job training signed on paper, classroom sessions and external online courses. Tracking completion across all of them was manual and fragmented.

What we did

Built a training system that presented current SOPs from the document management system page by page and tracked completion. On-the-job training forms carried a barcode identifying the trainee and the training, so signed forms were recorded automatically when scanned. The system also scheduled classroom sessions, recorded attendance and imported completions from external training platforms.

Outcome

Training records from paper, classroom and online sources were brought together in a single system, with completions captured as the training happened rather than entered later.

CS-04Founder experience

ERP-integrated shipping and dangerous goods documentation

Setting

Biotech manufacturer shipping regulated and hazardous materials

Role

Independent developer

Documents

Commercial invoices, dangerous goods declarations, bills of lading

Challenge

Shipping documents were prepared with significant manual entry, on documents where errors carry regulatory, customs and safety consequences.

What we did

Built a shipping database integrated with the company’s ERP that generated commercial invoices, dangerous goods declarations and bills of lading from controlled data.

Outcome

Shipping documents were produced from the same source data as the ERP, reducing manual re-entry and the risk of inconsistencies between documents.

CS-05Founder experience

Schedule attainment and right-first-time metrics

Setting

Biotech manufacturer, manufacturing, QC and QA

Role

Independent developer

Data sources

ERP work orders, Active Directory, Workday, equipment utilization, custom input forms

Challenge

Managers needed a reliable view of whether work was completing on plan as it moved through manufacturing, QC testing and QA release, and where batch record errors were recurring.

What we did

Built a reporting system that combined work order, staffing, time-off and equipment data to compare available and used labor hours and measure schedule attainment by location, product line and work center. Visual summaries supported tiered team meetings, and a right-first-time tracker recorded batch record corrections for trending.

Outcome

Planned versus actual performance became measurable across the full path to release, and recurring documentation errors became visible enough to address at the source.

CS-06Founder experience

Equipment downtime, maintenance and spare parts tracking

Setting

Biotech QC laboratory

Role

QC Systems Engineer

Platform

SQL Server, SharePoint, Microsoft Lists, Power Automate

Challenge

Instrument downtime, user-reported issues, spare parts and preventive maintenance were tracked in separate places, making it hard to see the state of the laboratory’s equipment at a glance.

What we did

Built a single system for downtime and issue tracking, spare parts inventory and preventive maintenance schedules, using platforms the company already owned.

Outcome

One view of equipment status and maintenance across the laboratory, on technology the company’s own staff could support.