TR-Print – Complete Control Over Every Test and Batch Record Print

Q: Can TR-Print be used for GMP and pharmaceutical batch records?

Yes. TR-Print was designed specifically for GMP and pharma traceable printing. It ensures that all printed batch records, labels, and analytical forms are produced from approved templates and remain fully traceable throughout the lifecycle. This helps QA departments demonstrate compliance during inspections and audits.

Traceable, compliant, secure

Book a Demo Explore Features

TR-Print dashboard with users, templates, print jobs and audit-ready notifications

GMP-ready

EU GMP Annex 11

FDA 21 CFR Part 11

ALCOA+

SaaS & On-Premise

The Problem: Printing as a Compliance Blind Spot

In many regulated industries — from pharmaceutical manufacturing to biotech and laboratories — digital data is well controlled. Validated systems such as LIMS, QMS, or ERP safeguard registration and traceability.

Yet the moment a document is printed, the process often falls outside that controlled chain. QA teams still manually approve, number, and record batch records to maintain traceability — a time-consuming and error-prone process. A wrong or missing print, a duplicate, or an unverified copy can lead to audit findings or delays in batch release.

TR-Print closes this gap — securing the last uncontrolled step between digital data integrity and paper-based process control.

When printing is not controlled, your audit trail is incomplete — even if your digital systems are validated.

Researcher in lab coat walking through endless stacks of paper records

Approved stamp placed on controlled document representing validated templates and compliant printing process

The Solution: Controlled Printing from Approved Templates

TR-Print is not a generic print tool, but a specialized application that brings the printing of test and batch records under full quality and compliance control — available as SaaS, on-premise, or in a hybrid configuration.

Within TR-Print, organizations upload approved document templates — such as test records, batch forms, or certificates of analysis. From these templates, controlled prints are executed, automatically assigned with:

a unique, non-reusable ID;
a sequential print number;
full audit trail.

After printing, the user confirms whether the printout was successful and meets physical quality requirements. Unreadable or defective prints can be marked as failed, and TR-Print records this automatically. The result: a complete and reliable audit trail showing exactly which records are in circulation, which failed, and which are pending.

TR-Print is available as SaaS, on-premise, or in a hybrid configuration — whichever fits your organisation's data and IT requirements. In every setup, a small TR-Print Node is placed on site behind the printer to create a secure print connection. No complex IT setup required.

How TR-Print Works

Upload Approved Templates

Upload validated versions of your test or batch forms into TR-Print. Only approved templates can be used for controlled printing.

Controlled printing with unique IDs

Each print job receives a unique ID and sequential numbering. All details — user, time, printer, and result — are logged automatically.

Confirm, verify, and reconcile

The user confirms that the print was produced correctly and is readable. Any failed or rejected print is flagged instantly, keeping your reconciliation up-to-date.

Secure archive & full traceability

All print data is securely archived. Every document, user, and deviation remains traceable — anytime.

One source. One ID. One auditable truth.

Bring Traceability to Your Print Process

Ready to remove printing as a compliance risk in your quality process?

Starting from €700/month · SaaS or on-premise · No complex IT setup

Book a Demo Call: +31 (0)85 016 5049

6 Key Features of TR-Print

Unique IDs & Sequential Numbering

Each printout is uniquely identifiable — eliminating duplicates, uncontrolled copies, and undocumented reprints

Manual Print Confirmation (Reconciliation)

Users verify that each print is successful and of acceptable quality. Failed prints are automatically logged.

Template-Based Printing

Only approved templates can be printed — ensuring consistency and version control.

Full Traceability & Audit Trail

All activities are logged automatically and instantly available for audits.

Audit-Ready Reporting

Automatic reports per batch, user, or time period — always inspection-ready.

Flexible Deployment

Available as SaaS, on-premise, or hybrid — manage templates, printers, and user rights centrally in every configuration.

TR-Print print wizard step 1 with selection of templates and quantities

TR-Print print wizard step 2 confirming selected documents and print status

TR-Print printed documents overview with record numbers, status and user info

TR-Print printed document details showing record code, status and audit notes

TR-Print reconciliation archive showing issued, returned, and outstanding test records per batch

End-of-Process Reconciliation

In GMP environments, printed test records must always be fully accounted for. Auditors expect clear proof that all issued records are either returned, archived, or properly explained. TR-Print automatically performs end-of-process reconciliation, giving full visibility over the lifecycle of every printed test record.

With TR-Print you can instantly see:

how many test records were issued
how many have been returned or archived
which records are still outstanding
who was responsible for them

Because every record receives a unique, non-reusable ID, missing records can always be traced back to the originating process or user. This level of reconciliation and traceability is highly valued during GMP and data-integrity audits.

Who TR-Print Is For

TR-Print is designed for organizations operating under GMP, ISO, or FDA regulations where printed documentation remains part of the quality process:

Pharmaceutical manufacturers – controlled batch record printing
Biotech companies – traceable test and analysis documentation
QC / QA laboratories – reconciled and traceable test forms
Medical device manufacturers – audit-ready production and QA records
Contract labs (CROs / CMOs) – demonstrably controlled print processes for clients

Why QA Teams Value TR-Print

QA teams need certainty — not assumptions. TR-Print eliminates manual print controls, ensures full traceability, and standardizes documentation integrity across sites. Less manual work, fewer audit findings, faster review cycles.

Significantly less manual approval and numbering work
End-of-process reconciliation of issued test records
Faster batch release and review cycles
Full traceability of all printed records
Consistent process across multiple sites

TR-Print controlled printing dashboard showing template selection, print status and reconciliation overview

Why Organizations Choose TR-Print

Printing used to be the last uncontrolled step in regulated environments — TR-Print closes that gap. It brings accountability, traceability, and reconciliation to every printed record, without changing your workflow. Simple to deploy, easy to use, and built for GMP compliance. Confidence in every print — from first copy to final reconciliation.

TR-Print is built for regulated environments where paper is still part of the validated process.

Total Control

Know exactly which prints exist, who created them, and whether they were approved.

Simple Implementation

Available as SaaS, on-premise, or hybrid — minimal IT effort in every configuration. Just one TR-Print Node per printer, no complex rollout required.

Proactive Insight

Real-time dashboards and reports simplify audit preparation and batch release.

Confidence in Every Record

Every document is unique, traceable, verified, and confirmed — removing doubt during inspections.

What Our Customers Say

"Before TR-Print, reconciling our batch records was a manual, error-prone process. Now every print is tracked automatically from issuance to return — our reconciliation is always complete, and auditors love it."

Sandra van der Berg

QA Manager · Pharmaceutical Manufacturer

"We used to spend hours each week manually numbering and approving print requests. TR-Print has cut that workload significantly. Our QA team finally has time for actual quality work instead of administrative tasks."

Mark Hendriks

Head of Quality · Biotech Company

"We evaluated several tools, but TR-Print was the only one built specifically for controlled printing in GMP environments. The implementation was smooth and the support team was excellent. We are very satisfied."

Laura Smits

QC Laboratory Manager · Contract Research Organisation

"We spent years managing print controls with spreadsheets and manual stamps. I wish we had found TR-Print sooner — it would have saved us countless audit preparation hours and at least two significant findings. Don't wait as long as we did."

Dr. Thomas Bauer

Quality Director · Medical Device Manufacturer

"During our last GMP inspection, the inspector asked specifically about print control. We opened TR-Print, pulled up the complete audit trail in seconds, and the inspection moved on without a single finding. That moment alone justified the investment."

Ingrid Koopman

Qualified Person · Pharmaceutical Manufacturer

See TR-Print in Action

Schedule a live walkthrough with our team. We'll show you how TR-Print fits into your current quality process — no lengthy RFP, no IT project required.

Book a Demo Call: +31 (0)85 016 5049

Frequently Asked Questions About TR-Print

What is traceable printing and why is it important in GMP environments?

Traceable printing means every printed document — such as a test record, batch record, or label — is uniquely identified, numbered, and logged. In GMP environments, this is essential for data integrity and compliance with regulations like Annex 11 and 21 CFR Part 11. TR-Print ensures every printout can be traced back to the user, printer, and approved template — eliminating uncontrolled copies.

How does TR-Print support GMP and regulatory compliance?

TR-Print automates secure printing processes, applies unique document IDs, and guarantees reconciliation of printed records. This makes every print traceable and always audit-ready for GMP, Annex 11, and FDA 21 CFR Part 11 inspections.

How does TR-Print improve data integrity?

TR-Print enforces data integrity by making the printing process itself controlled and auditable. Every print action is logged with who printed what, when, and why. Failed prints, duplicates or reprints are automatically tracked and included in reconciliation reports — supporting ALCOA+ principles of data integrity (Attributable, Legible, Contemporaneous, Original, Accurate).

Can TR-Print be used for GMP and pharmaceutical batch records?

Yes — TR-Print was designed specifically for GMP and pharma traceable printing. It ensures that all printed batch records, labels, and analytical forms are produced from approved templates and remain fully traceable throughout the lifecycle. This helps QA departments demonstrate compliance during inspections and audits.

Can TR-Print run in a secure on-premise or hybrid setup?

By default, TR-Print is a SaaS platform cloud-based with a small local TR-Print Node behind each printer. For organizations with strict data policies, on-premise and hybrid configurations are available. All data traffic is encrypted, and user authentication integrates with your existing security model.