GxP compliance services - QFINITY
QFINITY · Service · Holistic approach

Pars pro toto - the whole in view, building block by building block.

Modern companies are deeply integrated, both organizationally and technologically. In that environment, success comes from an approach that spans system boundaries - one that keeps technology, structures and business functions under control.

Discuss your requirements Our approach
Pars pro toto

The part stands for the whole.

Our guiding principle: connect the increasingly complex technologies behind every essential business process with your corporate structures and specialist departments - so you can master them permanently, across system boundaries. That doesn't have to happen all at once. It takes shape through logically coherent, self-contained building blocks placed along the timeline.

As with a jigsaw puzzle, the overall picture only makes sense once each piece sits in the right place.
Approach

Building blocks, connected along the timeline.

Inherent risk - the impact on data, product and patient - decides which block goes in when. The overall picture takes shape step by step, without ever losing sight of the whole.

  1. 1

    Assess

    Understand the business processes, the technologies and how they interact - the complete picture is your starting point.

  2. 2

    Prioritize

    Rank the building blocks by inherent risk - their impact on data, product and patient.

  3. 3

    Connect

    Tie logically related building blocks together across system and departmental boundaries.

  4. 4

    Master

    Keep the overall picture permanently under control - cost-aware and inspection-ready, even across system boundaries.

What this secures for you

Responsibly guided, inspection-ready results.

Risk-based guidance - across the board or in specific subject areas
Managed responsibly and cost-consciously
Customers involved right from the start
Established methods and tools, used deliberately
Organizational, project and quality goals met on time
Results that hold up in an audit and stand up to inspection
QFINITY · How we put it into practice

Consulting, training, audit - three paths, one standard of quality.

Discuss your requirements →
Consulting ↗Strategy and implementation for compliance, quality and risk management across the entire lifecycle. Training ↗Knowledge that empowers - training and workshops on general and specialized GxP/CSV topics. Audit ↗Supplier assessments and audits - strategy, planning and execution, remotely and on site.

Let's set the first building block together.

In an initial conversation, we map your processes and technologies and rank the next building blocks by their risk to data, product, and patient. The result: a prioritized roadmap along your timeline - about 30 minutes, free of charge.

Book an intro call