For managing directors & authorised officers · Life-science SMEs < 500 employees

The audit is coming. Your business must keep running.

Q: How soon can you support us?

We first clarify the audit date, scope, open items and available capacity. We then identify what can realistically be addressed before the date. We do not promise a fixed lead time or a successful audit.

Q: Do you prepare CDMOs for customer audits?

Yes. We define the relevant GxP processes and IT evidence with you and align preparation with the announced audit scope. Requirements outside our engagement are assigned transparently.

Q: Must every gap be closed before the audit?

Which actions are needed and by when depends on the finding and your quality system. We support assessment and prioritisation. Unfinished items are made visible with status, owner and next steps.

Weeks before an audit, your team searches for documents, explains inconsistencies and puts client projects aside. A customer audit may also affect the next contract. We make preparation needs visible and lead the agreed actions through to handover.

Arrange your free initial consultation

15 minutes · by phone · free of charge

What it means for your business

Being busy does not tell you whether you are ready.

A high document count can create an illusion of progress. As a managing director, you need different answers: Which gap is critical? Who will close it? Which items will remain open at the audit date? We turn these decisions into a manageable sequence.

Daily operations get displaced

When everyone is searching for everything, those same people are missing from production, projects and client support.

The wrong gaps get addressed first

A polished document achieves little if the underlying deviation remains unresolved.

Answers depend on chance

Without named contacts and aligned evidence, the person who happens to be available determines how well a question is answered.

What we deliver

A preparation plan that fits the time available.

Review audit scope and evidence
We clarify audit type, date, processes in scope and available evidence. A targeted assessment identifies gaps within the agreed scope.
Prioritise and address gaps
You receive actions with owners, dates and required decisions. We deliver the documentation packages we take on and track dependencies.
Prepare evidence and contacts
We structure the evidence, work through typical questions in the agreed subject area and document the remaining actions.

Agreed before we start

When is it finished?

The agreed preparation is complete when the evidence index is ready, commissioned actions are addressed, open items have owners and documented decisions, and the intended contacts know their materials. The auditor determines the audit outcome.

Clear responsibilities

Your team's contribution

You provide the audit notice, sources and contacts. Process owners verify actual implementation; your QA assesses and approves documents and actions under your quality system. Management decisions on remaining risks stay with you.

Delivery with a method and a workspace

IVE leads the work.
traqx supports delivery.

Our IVE method gives the engagement a clear structure: understand the situation, agree the scope, carry out the work and hand over the result. You know which decisions are needed and what defines completion.

Explore the IVE method →

Less document work. Clearer review.

traqx supports document work before the audit: Word drafts draw on agreed, approved sources. Changes, review status and history make revisions traceable. Your leading QMS or DMS continues to determine which records are authoritative for the audit.

Your existing QMS or DMS remains the authoritative system. Formal approvals follow your quality process.

See how we work with traqx →

From project experience

Experience you can assess.

Corporate experience · Validation under pressure. We took responsibility for validation workstreams and maintained delivery in demanding programmes.

See the project cases →

Before we speak

Your questions, answered.

How soon can you support us?

We first clarify the audit date, scope, open items and available capacity. We then identify what can realistically be addressed before the date. We do not promise a fixed lead time or a successful audit.

Do you prepare CDMOs for customer audits?

Yes. We define the relevant GxP processes and IT evidence with you and align preparation with the announced audit scope. Requirements outside our engagement are assigned transparently.

Must every gap be closed before the audit?

Which actions are needed and by when depends on the finding and your quality system. We support assessment and prioritisation. Unfinished items are made visible with status, owner and next steps.

The next step takes 15 minutes.

Click the button, choose a phone slot, and we talk briefly and honestly about your situation. Free of charge, and it commits you to nothing more.