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

The data exists somewhere. But what can you actually show?

One file is in the project folder, another in an inbox. Review status sits in a list that only one employee understands. Whenever a customer or auditor asks for evidence, the search begins. We make sources, status and open gaps traceable in the agreed area.

Arrange your free initial consultation

15 minutes · by phone · free of charge

What it means for your business

The risk lies between the files.

A new filing system alone does not explain where a result comes from or whether it was reviewed. You need a traceable connection between source, working version, review and authoritative evidence. We clarify this chain before producing more documents.

Every question consumes specialist time

Your staff reconstruct the history instead of relying on a traceable record.

Decisions use the wrong version

If drafts and approved versions are not clearly separated, teams may work from different information.

System changes leave unresolved evidence

When a system changes or is retired, it must be clear which data and evidence need to remain available afterwards.

What we deliver

A traceable evidence chain for the agreed area.

  1. Identify sources and the authoritative repository

    We map the relevant systems, documents and owners. With your specialists, we establish which source is authoritative for each piece of evidence.

  2. Expose and address gaps

    Within the agreed scope, we review provenance, version, review status and links. Missing mappings and documents become concrete tasks.

  3. Build the evidence index and handover

    You receive an evidence index with locations, owners and open items, plus the commissioned documents for your review.

Agreed before we start

When is it finished?

The package is complete when the agreed evidence is clearly mapped to its sources and locations, responsible staff can understand its status, and remaining gaps have documented decisions and owners.

Clear responsibilities

Your team's contribution

Your system and process owners provide sources and access and confirm the technical relationships. Your QA defines review, approval and retention rules. Retrospective reconstruction does not replace missing original data.

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 →
traqx

Less document work. Clearer review.

traqx connects document work with approved sources, producing Word drafts with visible changes, review status and history. This supports technical review. Original data, retention and formally approved documents remain in their designated authoritative systems.

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.

Mid-sized business · Software and analytics in a GxP environment. At HMS Analytical Software, the engagement ran from baseline analysis through implementation to staff training. Processes were scaled to company size.

See the project cases →

From baseline analysis through project management and effort estimation to implementation and staff training, every task was delivered highly competently and on time. Company-specific characteristics were kept in view throughout and the processes scaled accordingly.

Elisabeth KohmHMS Analytical Software

Before we speak

Your questions, answered.

Do we need a new DMS or QMS?
We do not assume that. We start with your existing systems and establish the authoritative sources. If a technical gap prevents the agreed evidence from being produced, we identify it separately.
Can missing original data be replaced retrospectively?
No. With your owners, we clarify what exists and is traceable, what gap remains and how it must be addressed under your quality system. A newly written report does not make missing original data available.
Does this also help before retiring a system?
Yes. We can target the scope to the relevant data and evidence. Technical migration, archiving and ongoing retention must be expressly agreed and coordinated with the responsible owners.

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.

Arrange your free initial consultation

15 minutes · by phone · no pitch