Custom compliant applications
When the right fix is new software, we build it, with audit trails, electronic signatures and validation support designed in from the first requirement rather than added at the end.
When custom software is the right answer
We don’t start with software. If a commercial product or a configuration change will solve your problem well, we’ll tell you. Custom development earns its place in situations like these:
- Your process is specific enough that no commercial product fits without heavy workarounds.
- The commercial options are far larger and more expensive than the problem you need to solve.
- Data has to move between systems, such as ERP, document management and instruments, that don’t talk to each other.
- A spreadsheet or paper process has quietly become a system of record.
- A legacy instrument needs its output captured as a controlled electronic record.
Compliance built in
Every application we build for a GxP environment starts from the same foundation, so the controls your inspectors expect are part of the design rather than an afterthought.
- Unique user identity through your existing directory and single sign-on, so every action is attributable.
- Complete audit trails recording who created, changed or deleted data, when, and why.
- Electronic signatures that show the signer’s name, date, time and meaning, permanently linked to the record.
- Role-based access so people can do exactly what their role requires, and nothing more.
- Protected data storage with backup and restore designed in from the start.
- Validation support including requirements, traceability and test evidence your Quality team can review.
| Signed by | M. Patel (mpatel) |
|---|---|
| Date and time | 2026-04-12 10:48:12 UTC |
| Meaning | Reviewed and approved for release |
| Authentication | Re-entered credentials at signing |
| Linked to | Batch record BR-2026-0187, version 3 |
What our founders have built
These are applications our founders designed and built in past roles for biotech manufacturing and laboratory environments. Employer names are never listed.
Training management
A training system that presents current SOPs from the document management system and tracks completion page by page. Printable on-the-job training forms carry a barcode identifying the trainee and the training, so signed forms are recorded automatically when scanned. It also schedules classroom sessions, records attendance and imports completions from external online training platforms.
Regulated shipping documentation
A shipping system integrated with the company’s ERP that generates commercial invoices, dangerous goods declarations and bills of lading from controlled data, reducing manual entry on documents where errors carry regulatory and safety consequences.
Instrument data capture
Capture of instrument output, including serial print output from older instruments, into controlled applications where results are stored as attributable electronic records with audit trails, ready for review.
Operations and quality metrics
Reporting that combines ERP work orders, directory and HR data, equipment utilization and user input to measure schedule attainment across manufacturing, QC and QA release, with visual summaries for tiered team meetings. Also right-first-time tracking of batch record corrections to reveal recurring errors.
Equipment and maintenance tracking
Systems for digital equipment use logs, instrument downtime and user-reported issues, spare parts inventory and preventive maintenance, built on platforms the client already owned so they could be supported internally.
How we build
Quality and IT are involved from the start, so the finished application is one both can accept.
We build with .NET, SQL Server and containerized deployment, hosted in your environment or the cloud, and integrate with your existing systems through their APIs. IT reviewers can find more on our security and architecture page.
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Requirements and risk
We document what the application must do, the records it creates and the GxP risk it carries, which sets the level of validation needed.
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Design review
Quality reviews the controls and records. IT reviews hosting, identity, integration and security. Both sign off before building begins.
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Iterative build
You see working software early and often, so feedback from the people who will use it shapes the result.
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Validation support
We provide traceability from requirements to testing, along with test evidence your Quality team can review and approve.
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Deployment and handover
The application goes live with documentation, user and administrator training, and an agreed plan for ongoing support and change control.
Products in development
We’re turning what we’ve learned into software products for regulated sites, starting with training management and laboratory data capture. If you’d like to help shape them as an early design partner, we’d like to hear from you.
Have a process that needs better software?
Tell us what it is and what you’re using today. We’ll give you an honest view of whether custom software is the right answer.