Qualitätswandel partners with Inpharmatic for digital transformation

Bresewitz, Germany: – Innovative pharma industry quality management specialists Qualitätswandel Dana Graupner GmbH has entered a dynamic partnership with Italian-based pharma software specialist Inpharmatic.

The collaboration is intended to boost take-up of Inpharmatic’s highly innovative software tools and now allows Qualitätswandel to offer digital transformation services backed by highly adaptable technologies.

Innovating clean production

Together, the two companies will exhibit from Stand AO.2 at the upcoming Lounges Cleanroom 2025 trade fair on 25th – 27th March in Karlsruhe to show how their respective expertise can transform sterile processes.

The Lounges Cleanroom Processes show will highlight how Inpharmatic technologies, combined with Qualitätswandel expertise in quality management, GxP, and regulatory compliance can generate a range of innovative solutions for clean production.

Qualitätswandel still has a few complimentary tickets left for the event that it can provide on request (see Resources).

Software suite

Inpharmatic develops digital tools for process optimization, with a software suite that includes three highly innovative solutions:

• DiBatch: This solution produces batch records without paperwork for greatly enhanced efficiency. Fully digital, accurate and GMP compliant, DiBatch automatically captures batch production data at source, with ‘Smart Check’ automatic validation and simple review processes. DIBatch produces transparent data for fast approvals for QA teams, much faster inspection times, easy integration with existing systems, and regulatory compliance – all boosting performance in production efficiency and Quality Control.
• DiForm: This technology for converting paper forms and logbooks into digital formats is a significant advance for the ‘Paper-on-Glass’ concept in which all workflows are digitized. DiForm also allows workflows to be re-engineered to be more intuitively, auditable and 100% paperless. The product is designed to be fast to implement and simple to use with no need for complicated training or system adjustments, highly flexible and adaptable to specific processes. It is also configured to be closely aligned with GxP requirements from production to quality control and with maximum compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and other guidelines on integrated document management & electronic signatures.
• Ioi Integration of Instruments: This solution brings the digital future direct to laboratories without replacing existing systems. The system eliminates risk of written transcription errors with all instrument data accurately and completely captured into the management system automatically. This Plug and Play solution will work with any LIMS, ELN or ERP without need for complex system changes. Guaranteed GMP compliance and alignment with enhanced Alcoa+ data integrity requirements, making this a perfect solution for audit trail and quality management systems.

Expertise meets technology

Having access to advanced digital tools is a key advantage that can only be leveraged with the right expertise and insights on how best to apply them for maximum advantage. This is where Qualitätswandel enters the picture, with its deep expertise and proficiency in quality management systems, regulatory affairs and pharma processes, including cleanroom production.

Posting on social media, Qualitätswandel Managing Director Dana Graupner commented: “The digital future of pharmaceutical and medical technology begins here- and we are right in the middle of it.”

“Qualitaetswandel.de is proud to be an official partner of Inpharmatic as a pioneer of digitization in the pharmaceutical and laboratory world. Our joint mission is to simplify processes, ensure data integrity and increase the efficiency of pharma processes”.

Qualitätswandel has hosted a series of podcasts over recent week on digitization of pharma, including a discussion presented by consultant Roman Ickert of a current project where it is working in direct collaboration with Inpharmatic (see Resources).

About Qualitätswandel Dana Graupner

Qualitätswandel Dana Graupner GmbH is a quality GMP consultancy and that helps companies, including those in the pharma and life sciences sectors make process transformations that require re-engineered quality management systems.

The company’s ‘Quality Change’ name encapsulates its mission to optimize quality management at organizational and systems levels. The company leverages its deep-rooted GMP and ISO expertise to help clients navigate the highly complex quality assurance landscape and achieve their goals. Its wide-ranging services include developing a GMP quality management system (GMP), ISO 9001 and ISO 13485, process analysis, training and audits.

The company offers customized services highly tailored to the individual needs of pharmaceutical and medical product manufacturers, as well as to clinical and pharmacy organisations, drawing on deep expertise in QM systems, project management, regulatory affairs management, documentation, cleanroom technology, risk assessment, and GAMP 5 CSV Computer Systems Validation.

Founded in 2019 by pharmaceutical quality expert Dana Graupner, Qualitätswandel is based at Bresewitz on Northern Germany’s Mecklenburg-Vorpommern Baltic Coast, with team members located all over Germany and connected online.

In its few years of operation, the company has already conducted scores of successful engagements, currently lists more than 40 client companies, and has been honoured with top consultancy awards for 2023 and 2024.

About Inpharmatic S.r.l.

Founded in 2017 and based in Milan, Inpharmatic’s mission is to deliver comprehensive and compliant solutions for the Life Science market.

Starting from expertise in adapting legacy laboratory instruments to current data Integrity requirements, Inpharmatic has gone on to develop a highly innovative suite of software solutions for Life Science industries. Its flagship solutions for paper-to-digital transformation are distinctive in the field in being applicable to any forms.

Inpharmatic’s proprietary technology facilitates the paper-to-digital conversion of paper checklists, logbooks, workbooks and batch records preserving their original layouts. Additionally, Inpharmatic has developed the Ioi platform able to capture, process and report transactional measurements from any kind of instrument.

In March 2025, Inpharmatic became part of the Italian-based Bluenext group of companies.

Learn more at: https://inpharmatic.it/en/

Resources

Click on Digitalization Project with Inpharmatic to listen to relevant podcast.
Message on https://www.linkedin.com/company/qualitaetswandel/ for Complimentary Ticket for Lounges Cleanroom 2025.