Our approach

From the first requirement to the day a system is retired, we can map and manage the complete validated lifecycle for you. Engage us to lead the whole process, deliver specific phases, or support your own team wherever you need another experienced hand.

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What guides our work

Proportionate to risk

Validation effort follows GxP risk, in line with GAMP 5 and Computer Software Assurance principles. Critical functions get rigorous testing; low-risk ones don’t consume the budget.

Quality and IT together

Both are involved from the first requirement, so the finished system is one both can accept, with no surprises at approval.

Documents that get used

Every deliverable has a purpose: supporting a decision, proving fitness for use, or guiding the people who run the system.

Traceable end to end

Each requirement is traced through design and testing, so you can show an inspector exactly how any requirement was met and verified.

Every specification has a matching verification

Validation follows a simple logic: what you specify on the way down, you verify on the way up. User requirements are confirmed in performance qualification, functional specifications in operational qualification, and design specifications in installation qualification.

Validation V-model Specifications descend on the left: user requirements, functional specification, design specification. The system is built or configured at the base. Qualifications ascend on the right: installation qualification verifies the design specification, operational qualification verifies the functional specification, and performance qualification verifies the user requirements. The process starts with a validation plan, request for proposal and proposal, and ends with a summary report and release. Begins with the validation plan, RFP and proposal Ends with the summary report and release URS User requirements FS Functional specification DS Design specification Build Develop or configure IQ Installation qualification OQ Operational qualification PQ Performance qualification verified by verified by verified by

The complete lifecycle, mapped

We can map every phase and deliverable for your system before work begins, so you know what will be produced, who approves it and how it connects to everything else. Then we can deliver all of it, or the parts you choose.

Plan

Define the scope, the GxP impact and the validation approach.

  • Validation plan and system risk assessment
  • User requirements specification (URS)

Select

Find the right solution, whether commercial, configured or custom.

  • Request for proposal (RFP) built from your requirements
  • Proposal evaluation and supplier assessment

Specify and build

Turn requirements into a documented, reviewable design, then build or configure it.

  • Functional specification (FS) and design specification (DS)
  • Configuration specification for commercial systems
  • Development or configuration, with design reviews

Verify

Show that the system is installed correctly, works as specified and fits its intended use.

  • Installation, operational and performance qualification (IQ, OQ, PQ) protocols and execution
  • Requirements traceability matrix
  • Deviation management during testing

Report and release

Close the project with a clear record of what was done and a system ready for use.

  • Validation summary report and formal release for use
  • Operating SOPs and user training

Operate and maintain

Keep the system in a validated state for as long as it’s in use.

  • Change control for fixes, upgrades and new features
  • Periodic review, access review and backup verification

Retire

Decommission a system without losing the records it holds.

  • Data migration or archival with verified integrity
  • Decommissioning plan and report

Work with us your way

Every organization has different internal capacity. We fit around yours.

Lead the entire lifecycle

We plan, author, execute and report the full validation, with your team reviewing and approving at each stage.

Deliver specific phases

Bring us in for the parts you need, such as writing requirements, evaluating vendors or executing qualification testing.

Support your team

Your people do the work and we provide expert review, guidance and a second opinion when it matters.

Validated systems still need to change

New versions, feature enhancements and fixes are part of a system’s life. Each one should go through a controlled process that keeps the system in a validated state without revalidating everything from scratch.

We can manage this for applications we build and for systems you already run.

  1. Change request

    The change is described, justified and logged under your change control process.

  2. Impact and risk assessment

    We determine what the change affects, its GxP risk, and exactly which documents and tests need updating.

  3. Specification updates

    Requirements and specifications are revised so the documentation matches the system as it will be.

  4. Build and targeted verification

    The change is implemented and tested, along with regression testing proportionate to the risk.

  5. Approval and release

    Traceability is updated, the change is approved, and the new version is released with clear release notes.

Founding partner program

ComplianTech is a new company. The experience behind it isn’t. Our founders have spent their careers inside regulated biotech, building validated laboratories, assessing instrument data integrity and managing quality systems.

We’re now establishing our client portfolio, and we’re looking for a small number of organizations to work with as founding partners.

Talk to us about partnering

What founding partners receive

  • Direct access to a founder throughout, with both founders reviewing every deliverable
  • Priority scheduling for your project and follow-on work
  • Partner terms discussed openly at the start of the engagement

What we ask in return

  • Permission to describe the engagement anonymously on our website: the type of organization, the challenge, what we did and the outcome
  • Never your name, products or confidential information without your written approval
  • Greater detail shared with prospective clients only under NDA, and only to the extent you agree

Planning a new system, or changing an existing one?

We can map the full lifecycle for you before the work begins, so you know exactly what it will take.

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