DEV Systems and data
Custom Software Development and Smart Inventory
If a task repeats, it can be automated. When an assessment or a validation reveals a problem or a process that can be simplified, we solve it with software. We build custom programs that automate tasks, organize data and reduce errors, following the life cycle a regulated environment demands. We also have our own product: DRP Smart Inventory, a system for managing the GxP inventory of pharmaceutical laboratories.
Signals
When do you need it?
- A task is done by hand every dayCopying data between systems, consolidating spreadsheets or building reports nobody enjoys.
- We spotted a bottleneckAnd it's better solved with a simple tool than with yet another procedure.
- Your lab runs on spreadsheetsMaterials, equipment, systems and suppliers with expiry dates that depend on someone remembering.
- Commercial software doesn't fitOr an off-the-shelf product would be expensive and overkill for what you need.
Approach
Software that simplifies, built to be validated
Often the problem surfaces in the middle of other work: a record filled in twice, a calculation redone by hand, a follow-up that depends on someone's memory. Instead of adding more paperwork, we build a tool that solves it, right then and tailored to your operation.
Because it's custom software in a GxP environment, we build it following the life cycle GAMP 5 requires for Category 5: requirements, design, version control, testing and documentation. That way it's ready to be validated instead of becoming a new audit finding.
If a task repeats every day, it deserves a program, not another spreadsheet.
How we do it
Service stages
- 01DiscoveryThe process or problem, its cost and its GxP impact.
- 02RequirementsWhat it must do, defined with the people who use it.
- 03DevelopmentShort iterations tested with real users.
- 04TestingVerification traced to requirements, with evidence.
- 05Go-liveTraining, support and continuous improvement.
Regulatory framework
What the regulations require, point by point.
These are the references we work with for this service. We apply the ones that fit your market and your type of product.
ISPE GAMP 5 Second Edition
- Category 5 · custom softwareFull life cycle: specification, design, code review, testing and configuration management.
- GAMP GPG: Enabling InnovationAgile and iterative methods applied to regulated systems.
FDA United States
- General Principles of Software ValidationValidation principles for custom-developed software.
- 21 CFR Part 11When the tool creates or stores GxP records: audit trail, access and signatures.
EU GMP EudraLex Volume 4
- Annex 11 §4Validation of bespoke systems developed under an appropriate quality management system.
ISO Development good practices
- ISO/IEC 27001Secure development, access control and change management.
Deliverables
What you get.
Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.
- Assessment and solution proposalThe problem, the chosen approach and its scope, before writing any code.
- User requirements specification (URS)What the software must do, agreed with its users.
- Working custom softwareA concrete tool that automates or simplifies the process.
- Versioned code and technical documentationDesign, configuration and change history.
- Documented testing and traceabilityEvidence ready for system validation.
- Training and user manualYour team uses the tool from day one.
- DRP Smart Inventory deployedWhere applicable: installed, configured for your laboratory and with your team trained.
FAQ
What clients ask before we start
What is DRP Smart Inventory?
It's our system for managing pharmaceutical laboratory inventory: materials, equipment, computerized systems and suppliers, with expiry dates, alerts and full traceability. It's designed to support compliance with 21 CFR Part 11 and Annex 11. Like any GxP system, it's validated within your organization before production use, and we support you through that process.
Can the software you develop be validated?
Yes. We build it following the GAMP 5 life cycle for custom software, so the documentation and testing already support the validation.
How long does development take?
It depends on the scope. Many tools are delivered in weeks through incremental releases. We define scope and schedule before we start.
Works well with
Related services
-
QA·IT
IT quality management
Without an inventory, criticality and QA IT policies, every validation starts from scratch.- GxP inventory
- GAMP 5
- PIC/S PI 011-3
-
CSV
System validation (CSV)
LIMS, ERP, MES, SCADA or QMS that must prove they do what they claim.- GAMP 5 Second Edition
- 21 CFR Part 11
- EU GMP Annex 11
-
XLS
Excel spreadsheet validation
Spreadsheets that calculate results, yields or stability and that nobody has validated.- GAMP 5
- 21 CFR Part 11
- EU GMP Annex 11
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.