Digital qualification processes on a new level

SKAN AG, a global leader in cleanroom and isolator technology, faced a major challenge: manual management and documentation of qualification processes increased the time required, complicated processes, and increased the risk of errors. Together with brix Solutions AG, the requirements for a digital solution were recorded and comprehensive specifications were drawn up to serve as the basis for a software tender.

Industry

Pharmaceutical and biotech industry

Founded

1968

Company locations

Headquarters in Allschwil, Basel-Landschaft – other locations in Brazil, Germany, Japan, and the US in addition to Switzerland.

Employees

1000+

Initial situation

Challenges

SKAN AG's qualification processes were heavily paper-based. This led to several challenges:

High manual effort

Qualifications were managed using Word and Excel documents, which made documentation time-consuming. SKAN also wanted to further reduce the risk of errors.

Distributed storage

There was no central database for qualification reports and test protocols, which posed a challenge for traceability and overview.

Compliance with regulatory requirements

GMP compliance required complete documentation and versioning.

Standardization of qualification reports

The existing processes in the Process Solutions and Pure Solutions divisions differed greatly. Standardization made it possible to increase efficiency and ensure high quality in the long term.

Quantity structure of qualifications

The following figures illustrate the complexity and scope of the qualification processes to be digitized:

Extensive customer base with high quality requirements
Several hundred qualifications and requalifications per year
Over 100 different types of equipment
Over 1000 test devices
Several dozen SOPs
150 directly affected employees

A solution had to be found that would digitize and standardize these processes and ensure compliance.

3 Thomas Kämmerle 2026 Original 326x326

Through close cooperation with brix Solutions AG, we were able to ensure that all requirements were fully captured. The structured approach made it possible to create a solid basis for the digital transformation of our qualification processes.

Thomas Kämmerle

Project Manager, SKAN AG

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Solution

To create the basis for a future-proof, automated qualification solution, brix Solutions AG worked with SKAN to develop a comprehensive functional and technical foundation. Careful analysis of existing processes, precise recording of all requirements, and structured development of key specifications resulted in a complete and robust specification sheet. This document formed the basis for the software tender and ensured that all functional, technical, and regulatory requirements were clearly defined and comprehensible. The following measures were implemented as part of this work:

Workshops were conducted and interviews were carried out to comprehensively record requirements.
System archaeology was performed to analyze existing processes and structures.
Six actual processes were collected and documented.
Framework conditions and boundary conditions were defined.
A system context diagram was created to illustrate the interfaces and dependencies.
A detailed system analysis was performed.
A rough class diagram was created and the relevant objects were specified.
A state diagram was created to illustrate the life cycle of the qualification reports.
Defined IT security requirements in the GxP environment.
Created an authorization concept to regulate user access rights.
Three target processes identified to describe future working methods.
Six use cases defined to map typical application scenarios.
Non-functional requirements formulated to set technical and regulatory framework conditions.
Project approach structured and documented.
102 requirements written to create the basis for software development.
A price sheet for the license and development costs was created.
A glossary and a list of abbreviations were created to ensure consistent terminology.

Results & successes

The structured recording and documentation of requirements led to the following successes:

A solid basis for the software tender was created.
Standardized and uniform processes for future qualification were defined.
A high level of traceability and transparency in the requirements documentation was ensured.
Regulatory compliance is ensured by clear specifications.

Conclusion & outlook

The development of the specifications and the detailed requirements analysis were a complete success. The next step is the tender for the software solution and the implementation of the digital platform.

Why was this project successful?