Secure processes.
Reliable results.
With tailored, digital and GxP-compliant solutions, we take your computerised systems to the next level – efficient, secure and future-ready.
High quality.
Assured compliance.
Since 2017, we have been bridging the gap between software vendors and users, using innovative, digital and GxP-compliant strategies to achieve the highest audit and compliance standards. Our tailored approaches make complex requirements manageable – always with your individual processes in mind.
- GxP consulting, validation and training of the highest standard
- Tailored support for your specific GxP requirements
- Greater audit readiness and compliance through precise documentation
- Holistic approaches for sustainable, future-proof processes
Years of experience
in the GxP environment
Years of experience
in method validation
Years of experience
with laboratory software
Years of experience
in the laboratory environment
Your challenges.
Our expertise.
Many companies in the pharmaceutical and laboratory sector face similar hurdles when it comes to GxP compliance and audit readiness:
Lack of overview of GxP regulations
The complex requirements of GxP regulations and CSV (computerised system validation) pose major challenges for many companies.
Implementing GxP regulations
Clear, actionable guidance for reliably ensuring compliance is often missing.
Missing documentation
Inadequate or incorrect documentation can delay audits and increase compliance risks.
Rising demands during audits
Regulatory standards and audits are becoming increasingly complex and require specialist support.
Our solutions deliver not only audit readiness and compliance but also efficiency and future-proofing for your systems.
GxP Consulting
As experts in GxP regulations, we help pharmaceutical companies reliably align their quality systems and processes with regulatory requirements. We make sure you pass audits with confidence and bring your products to market safely.
Quality Documentation
Benefit from our many years of experience in creating, validating and maintaining quality-relevant documentation. We support you with QMS-compliant SOP writing, computerised system validation and audit preparation in regulated environments.
Chromeleon Services
Our Chromeleon Services help you realise the full potential of Thermo Scientific™ Chromeleon™ CDS. Whether through training, workshops or individual consulting, we support you in implementing, qualifying and efficiently using Chromeleon™ in regulated environments.
On-Demand Software Development
Drawing on many years of software development experience, our partner Qpliance Data Services GmbH delivers tailored solutions: reliable, scalable and precisely matched to customer requirements. From initial idea to finished application, Qpliance Data Services GmbH manages the entire development process professionally, efficiently and in line with GxP.
These clients value our quality and expertise.
Our values.
Our drive.
What does Qpliance stand for?
The vision of making GxP processes not only simpler but also safer. Our mission is to develop practical solutions that add value and make our clients’ day-to-day work noticeably easier. Through consistent quality and innovative approaches, we aim to build lasting trust and foster sustainable partnerships.
Vision
A world in which our clients see change as an opportunity and use future technologies to safeguard everyone's health for the long term.
Mission
By applying current regulations and best practices efficiently, we show our clients practical ways to make successful use of change and future technologies.
Motto
“Optimise processes. Live audit readiness. Shape the future.”
Frequently asked questions
Here you will find answers to frequently asked questions. If you have a different question, please feel free to get in touch with us at any time.
Qpliance supports pharmaceutical companies with GxP-compliant solutions such as consulting, validation, Chromeleon services and IT services to make audits safe and efficient.
Our services are aimed primarily at medium-sized to large pharmaceutical companies, including laboratory managers, QA/IT staff and Qualified Persons.
We advise on numerous GxP regulations, including the EU GMP Guidelines, 21 CFR Part 11, ISPE GAMP® 5, the German AMWHV (Ordinance on the Manufacture of Medicinal Products and Active Substances) and many more.
With tailored documentation, validated software solutions and structured training, we significantly increase audit readiness and compliance.
One example is our data migration tool, which enables automated, validated data migrations with 100% data comparison – for maximum efficiency and security.
Our solutions are specifically tailored to the requirements of pharmaceutical companies and take individual needs and processes into account.
Personal support, trust, high quality and more than 130 successfully completed software validations give us a unique combination of experience and innovation.
Thanks to our experience, we cut project time by an average of 30% when introducing new laboratory software – efficiently, safely and reliably.
Your enquiry –
we are here for you!
Do you have questions about our services or would you like to learn more about our tailored GxP solutions? Simply fill in the form and we will get back to you as soon as possible. Together, we will find the right solution for your requirements.
Our publications
Here you will find white papers that provide clear answers to complex questions.
