Toggle Engineering
Risk-based Computer System Validation for regulated automation environments — from strategy and qualification through operational lifecycle management.
Validation in regulated industries is under pressure from two directions at once. Regulatory expectations are moving — the FDA's 2022 CSA Guidance and GAMP 5 Second Edition both push away from documentation-heavy compliance theatre toward critical thinking, risk-based assurance, and early defect detection. At the same time, the systems being validated are more complex than ever: custom-coded, cloud-hosted, Agile-deployed, and tightly integrated with MES, ERP, and process control layers. Operational Technology is moving from traditional PLC/DCS systems towards open SDA — Software Defined Automation — systems.
Traditional paper-based approaches — disconnected Word documents, manually re-executed test scripts, traceability matrices maintained in Excel — are structurally misaligned with how modern systems are built and maintained. When the underlying code changes, every document is stale. The traceability matrix is the first to lie.
Toggle Engineering delivers validation engagements built around how systems are actually developed. For GAMP 5 Category 5 custom-coded systems, we go further: we use a purpose-built validation platform that generates the full V-model document set directly from the codebase, drives every deliverable through a structured review-and-approval workflow, and produces a hash-sealed, auditor-ready validation release — in weeks, not months.
Pillar 01
Validate what matters. Document what's needed.
The FDA's Computer Software Assurance guidance marks a deliberate shift: from prescriptive documentation of every test step to a critical thinking–driven approach where testing effort is proportionate to patient safety risk and product quality impact. GAMP 5 Second Edition reinforces the same direction — built-in quality assurance throughout the software development lifecycle, not a final-stage document exercise.
We translate that regulatory intent into a practical validation strategy for your project or system portfolio — one that satisfies inspectors without burying your team in documentation overhead that adds no quality value.
Why it matters
"More than 60% of defects are introduced in the requirement and design phase — not during execution. A validation strategy that only activates at the end of the project is not quality assurance. It's a final exam with an already-fixed answer."
Pillar 02
Documents derived from the system. Not reconstructed from memory.
Why it matters
"The validation package is not a reconstruction of what was built. It is the system — viewed through a compliance lens, anchored to the same source of truth, and sealed at the moment of approval."
For GAMP 5 Category 5 custom-coded systems — process control software, environmental monitoring systems, building management IACS layers — the full V-model applies. All deliverables, every change rippled through every document, every signature defensible to an inspector.
We deliver this using a platform built by Toggle Engineering that wraps the GAMP 5 lifecycle around the actual codebase. You provide the URS, the source tree, and an in-code traceability map. The platform generates the complete V-model document set, drives each deliverable through an Author → Reviewer → Approver workflow, executes the automated test suite as formal OQ/PQ evidence, and bundles the approved versions into an immutable Validation Release. Every approved version is SHA-256 stamped. The result is a complete, auditor-ready validation package in weeks rather than months.
Pillar 03
Go-live is not the finish line. It's where the system starts changing.
The validation challenge for most regulated systems does not end at go-live. Custom-coded systems accumulate change requests, patches, and incremental releases — each of which has the potential to place the system outside its validated state unless each change is anchored to a documented, defensible qualification record.
The modern answer to this is not to slow down development. It is to make the development pipeline itself the source of qualification evidence. In a properly configured CI/CD environment, every commit carries a git SHA — a precise, tamper-evident reference to the exact version of the code under test. Every automated test run against that commit is a candidate qualification record.
We design and implement that governance layer: structuring your pipeline so that change control triggers the right test runs, formal qualification runs are marked, witnessed, and SHA-anchored, and the traceability matrix stays current with every release — without requiring a full re-qualification cycle for every change.
Why it matters
"Your CI pipeline already runs the tests. The question is whether those results are governance-grade evidence or just engineering noise. The difference is not in the tests themselves — it is in the traceability, the intent declaration, and the SHA that ties the result to an exact version of the system."
Integrated
For clients engaging Toggle Engineering on a capital automation project, CSV/CSA is available as an integrated workstream from the start. Validation planning begins at FEED, qualification protocols are written in parallel with engineering design, and the handover package includes a fully validated system — not a documentation backlog to resolve after go-live.
Get Started
Let's talk about how a risk-based, code-anchored validation approach can simplify your qualification effort — and produce a validation package that holds up under inspection.
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