Leida Bridge

    Building blocks for real-time change control shared by developers and QA

    Bring developers and QA into the same release-tied change set, with evidence gates, a decision trail and controlled outputs that stay audit-ready.

    What Bridge does for developers
    through integrations

    Bridge meets developers where work already happens. Integrations and plugins surface the compliance change set inside existing tools, so developers can review what changed, attach evidence, and complete required tasks without switching into Leida. Bridge keeps the release context intact and carries the right signals and artifacts forward, so engineering work remains engineering-native while still becoming part of a controlled evidence trail.

    What Bridge does for QA and
    regulatory decision-making

    Bridge turns technical change into an approval-ready view. The QA and regulatory side translates commits, tickets, configurations, tests and release signals into plain-language impact, evidence gates, and a clear decision path. Both sides stay anchored to the same underlying change set. Bridge brings them together into one approved snapshot that can be exported into an existing eQMS or promoted into Leida QMS when Leida is the system of record.

    Bridge actions

    • Open a release-tied change set from an integration or plugin, without requiring developers to switch tools.
    • Pull Core proposals and engineering context into one shared change set that both sides work from.
    • Turn the compliance delta into clear tasks and evidence requests tied to the release.
    • Collect evidence from engineering work and keep it attached to the exact change.
    • Present the same change set in two role views: developer view for execution and QA view for decision-making.
    • Run evidence gates in real time and show what is required, what is present, and what is missing.
    • Capture questions, assumptions, rationale, and the final decision trail inside the change context.
    • Freeze the approved snapshot so the reviewed state cannot drift after sign-off.
    • Produce controlled outputs for export to an existing eQMS or promotion into Leida QMS.

    Inputs

    • Core proposals: impact map, required updates, evidence checklist, draft edits, and recommended decision paths.
    • Engineering signals: commits, PRs, branches, tags, diffs, dependency updates, configs, feature flags, release metadata.
    • Verification signals: CI results, test reports, coverage, protocol outputs, screenshots, validation artifacts.
    • Working context: internal SOP criteria, acceptance thresholds, release gates, and organizational review rules.
    • Existing evidence: approved documents and records from an eQMS or Leida QMS, used as the baseline for comparison and control.

    Outputs

    • A release-tied, shared change set that combines engineering context, evidence, and QA decisions.
    • Two synchronized role views: an engineering-native execution view and an approval-ready QA decision view.
    • Evidence gate status: what is required, what is present, what is missing, and what is blocking release readiness.
    • Final decision trail: approvals, requested changes, timestamps, and the rationale summary that becomes the official record.
    • Frozen snapshot: an immutable, approved state for inspection safety and traceability.
    • Controlled exports: audit-ready evidence outputs for filing into an existing eQMS.
    • Promotion-ready records: approved snapshots mapped into Leida QMS when Leida is the system of record.
    Input from Leida Core
    Leida Bridge
    Developer/Product Team View

    Compliance Pull Request

    • Open the change set tied to a release tag or branch
    • Review what changed from engineering sources
    • Complete required evidence tasks for the release
    • Attach evidence such as test reports, CI logs, screenshots, and protocol outputs
    • Respond to QA questions and record context
    • Track blockers and readiness
    QA/Regulatory View

    Decision Workspace

    • Review the rationale summary
    • Inspect the impact map: intended use, claims, risk file, cybersecurity, labelling, PMS, training
    • Evaluate evidence gates: what is required, what is present, what is missing
    • Ask questions and clarify assumptions
    • Choose the decision path: ship EU/US only, ship with feature flag off, hold release, require extra verification
    • Approve, reject, or request changes
    • Freeze the approved snapshot for promotion
    Freeze Snapshot
    Promote to Leida QMS
    Export to existing eQMS

    Connect the tools the team already uses

    Bring Jira, GitHub or GitLab, and test systems into the evidence chain so change signals arrive automatically and work stays in the tools people already live in.

    Bridge for release decisions

    Evaluate every release in a shared change set with two role views, developer execution through integrations and QA decision-making in an approval-ready view, then freeze the approved snapshot.

    Audit and submission exports

    Generate controlled exports from the approved snapshot, including traceability and risk evidence, ready to file into an existing eQMS or promote into Leida QMS.

    The Bridge advantage

    Built for teams that ship continuously and need evidence to stay approval-ready.

    Align developers and QA on every release

    Review the same release-tied change set from two role views, engineering-native for developers and approval-ready for QA, so decisions happen in real time instead of late meetings.

    Turn change into controlled traceability and risk evidence

    Keep requirements, tests, and risk controls tied to the release, then export an approved traceability matrix and risk evidence from the frozen snapshot, without manual spreadsheet reconstruction.

    Freeze the approved state and ship with confidence

    Capture the decision trail, freeze the approved snapshot, and produce controlled outputs for export to an existing eQMS or promotion into Leida QMS, so evidence cannot drift after sign-off.

    Problem it addresses

    Moving from documents directly from drafting into the QMS creates a bottleneck. Teams need a safe place where regulatory reasoning, evaluation, debate, and evidence collection happen before anything becomes authoritative.

    Why this exists

    Bridge is the pre-commit zone. It holds intent, drafts, deltas, questions, evidence and decisions. It makes compliance review a structured workflow, not email archaeology. It preserves human authority. It batches changes into coherent packages per release or regulatory event.

    How the problem is solved in practice

    Core creates proposals. Bridge phase groups proposals into a change set. Developers attach evidence and complete tasks. QA evaluates impact and rationale in real time, asks questions and selects the best compliance path. Only approved, frozen snapshots can be promoted into QMS.

    What it makes easier, simpler, faster
    • Understanding exactly what compliance work is required for a release
    • Seeing compliance impact as a delta, not a massive checklist
    • Completing required work without meetings and email archaeology
    • Understanding what changed and why – in one place
    • Seeing evidence gaps clearly and early
    • Choosing the lowest-risk regulatory path for a release
    • Producing inspection-ready rationale without extra work
    Main users

    Engineering teams, QA/RA teams, product/engineering managers.