Paid Diploma / Master's Thesis - A methodological framework for the digital transformation of integrated management systems (IMS)

Paid Diploma / Master's Thesis

A methodological framework for the digital transformation of integrated management systems (IMS)

Ref No. DA198

To dedicated students of Environmental Systems Sciences, Business Administration, Business Informatics, Software Engineering, Industrial Engineering, Pharmaceutical Engineering, Biotechnology, or related disciplines.

OBJECTIVE

A research organization working for GxP-regulated partners has to be auditable and fast-moving at once. RCPE is not itself a GMP manufacturing site, but operates an integrated Quality & Environmental Management (QEM) system aligned with ISO 9001, ISO 14001, and ISO 90003. In research the routines, experimental designs, and laboratory setups change by nature, so a rigid compliance system would work against the science. The QEM system still runs largely on documents, which limits traceability and scalability. That tension between traceability and research flexibility is what makes replacing it a design problem rather than a configuration exercise.

The difficulty is not the standards themselves. The Harmonized Structure of the ISO/IEC Directives gives ISO 9001, ISO 14001, and ISO 27001 the same clause sequence, core text, and vocabulary, so integration at the level of the management system frame is well understood. The operational layer is not, and that is the layer an electronic management system has to render as concrete objects, workflows, and records. Environmental aspects, the Annex A control set of an information security management system, and the software guidance of ISO 90003 do not reduce to one another, and a shared clause number does not decide whether an environmental aspect register and an information security risk register are one entity or two, or whether one corrective-action object can carry nonconformities from several standards without collapsing into a lowest common denominator. Nor is the answer supplied by the market: the eQMS landscape is largely built around ISO 9001 and GxP quality logic.

The timing sharpens it. ISO 14001 was reissued in April 2026 and a new edition of ISO 9001 is expected in autumn 2026, each with a three-year transition, while ISO 90003 remains guidance keyed to the 2015 edition. An architecture designed now must absorb those transitions, and a later extension to ISO 27001, without being rebuilt.

The objective of this thesis is to develop, apply, and evaluate a structured methodology for the digital transformation of a multi-standard QEM system, and to establish how far such an architecture can be made extensible by design. Embedded in the QEM team from analysis through to implementation, the work should be validated against real organizational dynamics.

The work is analytical and organizational rather than software development; programming skills are not required. Familiarity with requirements engineering, process modeling, management system standards, or structured decision-making methods is an advantage; prior GMP or GxP experience is not expected.

Candidates from pharmaceutical engineering, biotechnology, or process engineering bring something specific to this project: the processes being digitalized are laboratory and development processes, and knowing from the inside what those actually look like counts for a great deal. For them the thesis is also a route into the systems and compliance side of a research organization in a GxP-regulated field.

Research Questions:

• Given that the management system frame is already harmonized, where does integration actually have to be engineered? Which topics of a QEM data model can be shared across the three standards, and which must stay standard-specific to preserve auditability?
• How should the criteria model for the software selection be derived from clause coverage and operational requirements, so that a Multi-Criteria Decision Analysis yields a reproducible recommendation rather than only a pure ranking?
• How must the architecture be structured so that a further standard (ISO 27001, with its Annex A controls and Statement of Applicability) and new editions of standards already in scope can be integrated without re-engineering existing objects?

Work Packages

Five work packages, whose relative depth is agreed with the supervisors at the start, in line with the requirements of the respective degree program.

• Analyze the current QEM processes and map the clauses of the three standards, separating what the Harmonized Structure already aligns from what remains discipline-specific.
• Elicit and formalize functional, technical, and regulatory requirements using established techniques such as Volere, including traceability and auditability.
• Survey the eQMS market from primary vendor documentation, build the criteria model, and apply a formal method such as AHP or TOPSIS with documented weighting and a sensitivity analysis.
• Co-engineer configuration and deployment, translating document control, audits, CAPA, risk management, and environmental aspects into digital workflows, and documenting friction points in migration.
• Evaluate the result against baseline efficiency and audit-readiness metrics, and derive a generalized framework for absorbing further standards and new editions.

WITHIN THE FRAMEWORK OF THIS DIPLOMA / MASTER’S THESIS WE OFFER THE FOLLOWING:

• Ownership of a self-contained, industrially relevant digitalization project in a professional, international environment
• Structured supervision and training, with experienced staff supporting the implementation of new, innovative ideas
• Assistance with the publication of results

At a glance

Start: Autumn 2026, exact date by arrangement

Language: English is the working language, level B2 required – German is an advantage.

Location: RCPE, campus of Graz University of Technology, Inffeldgasse, Graz

Compensation: on the basis of a service contract

Not just a thesis: the intention is to continue the collaboration afterward, first as a part-time student employee, then as a full member of the RCPE QEM team – a role covering internal audits, document control, and training development, and one that grows as RCPE’s certification scope grows. Applications are reviewed on a rolling basis.