Find the data integrity gaps before an inspector does.
ComplianTech helps GxP laboratories and manufacturing sites assess and harden their QC and production systems, especially the legacy ones, and builds compliant software when existing tools fall short.
| Timestamp (UTC) | User | Action | Reason |
|---|---|---|---|
| 09:02:41 | jlee | Sequence acquired | n/a |
| 09:14:07 | jlee | Integration events modified | Baseline drift, per SOP-QC-112 |
| 09:15:30 | jlee | Results reprocessed | Following integration change |
| 10:48:12 | mpatel | Reviewed and approved | Second-person review |
Legacy systems are where data integrity quietly breaks down.
Data integrity remains one of the most common themes in FDA warning letters and inspection observations. The gaps usually aren’t in new, well-validated platforms. They’re on the instrument workstation in the corner of the QC lab, the spreadsheet that became a system of record, and the paper-and-electronic process nobody has looked at end to end.
These systems still produce GxP data, so they’re held to the same expectations as everything else.
What our founders have seen in regulated labs
- Shared or generic logins on instrument workstations, so results can’t be attributed to a person.
- Audit trails that are disabled, incomplete, or never reviewed as part of release.
- Raw data stored on local drives with no reliable backup or archival.
- Unsupported operating systems that can’t be patched or replaced without revalidation.
- Hybrid paper and electronic records where the true original is unclear.
- Users with administrator rights who can delete or overwrite data.
Start with a Data Integrity Assessment.
A fixed-scope review of your QC and manufacturing systems, their data flows and the procedures around them. You get a clear, risk-ranked picture of where you stand and a practical plan to close the gaps, in an order that makes sense for your budget and your inspection timeline.
Explore the assessmentWhat you receive
From findings to fixes.
The assessment tells you what needs attention. These services close the gaps, whether the answer is configuration, process, validation, or new software.
Bring aging instrument systems and workstations up to current expectations without a forced replacement. Access controls, audit trail configuration, centralized data capture, backup and archival, and the procedural controls that support them.
Strengthen the processes around your data: hybrid records, review and approval practices, data lifecycle management, and SOPs that match how work is actually done on the floor.
Risk-based validation strategy aligned with GAMP 5 and CSA, Part 11 and Annex 11 readiness, system selection, and preparation for inspections and audits.
When remediation calls for new software, we build it: instrument data capture, training records, controlled forms and regulated shipping documentation, designed with audit trails, electronic signatures and validation in mind from the start.
Why work with ComplianTech
Built in regulated labs
Our founders have spent their careers inside biotech companies, building validated laboratory environments and running QC operations. They know the regulations and what the lab floor actually looks like.
Practical remediation
We harden and modernize what you already have before recommending replacement. Fixes are sized to your risk, your budget and the validation effort they’ll require.
Able to build the fix
When the right answer is new software, the same team that found the gap can design and build it, so recommendations don’t stall waiting on another vendor.
You work directly with the person doing the work, from the first call to the final readout.
Selected founder experience
ComplianTech is a new company. These examples come from our founders’ past experience in regulated biotech, not from ComplianTech engagements. Employer names are never listed.
See all case studiesValidated QC laboratory setup
Founder experience: planning, setting up and validating a QC laboratory with a primary focus on automation and data integrity. The lab layout was designed for efficiency, to avoid material cross-contamination, and to eliminate interference from vibration, RFI/EMI or heat.
Dangerous goods and export documentation system
Founder experience: one of our founders led a team that created a database platform for dangerous goods and international shipping documentation. This application pulled delivery data from the ERP system, aggregated deliveries to the same entity, generated Container Labels, Commercial Invoices, Hazardous Declarations (including overpack functionality), and Bills of Lading.
Know where you stand before your next inspection.
A short scoping call is enough to define the assessment and give you a fixed quote.