Quality and compliance 2017-11-06T15:45:28+00:00

Creating a quality culture

We help clients establish industry-leading Quality and Compliance operations throughout the drug development life cycle.
Helping Q&C teams directly influence business change

Pharmaceutical Quality Assurance and Compliance groups  are under pressure due to the growing complexity of global operating models.

Compliance is a must,  but you’re constrained by limited resources and everything cannot be “top priority”. To get ahead, simplified, risk-based approaches, supported by a quality culture across your organisation are imperative. Kinapse’s four stage robust Quality and Compliance approach will help you achieve this:

The Pharmaceutical Quality and Compliance process from Kinapse.
“Quality & Compliance is the foundation of a quality culture. Kinapse believes that for a business to be successful, quality must be owned by the whole organisation and embedded in its culture.”
– Jean Samuel, Kinapse CQO.

We recognise how important Q&C teams really are in enabling successful Pharmaceutical research and development, and defining a Pharmaceutical business’s success. But, in our experience these groups are often under-valued and in some cases, can be perceived as working against the drug development process.

We know how to help QA teams change that perception, remove internal tension, improve their performance and demonstrate their value by:

  • Supporting in-house Q&C teams

    We help Quality and Compliance teams assess, define and improve their current processes. This includes developing RACI matrices, building SOP frameworks, writing SOPs and operating CAPA management activities on your behalf.

    Our team of Quality and Compliance professionals have worked in the industry for many years. We’re backed up by a network of experienced consulting partners who can support us and clients with local requirements and regulations.

  • Building reliable quality and compliance controls

    We guide clients through the process of creating risk-based approach to their Quality Management Systems: providing risk assessments and implementing KQIs to manage and improve upon quality and compliance controls over time. We also help you to remain audit-ready and provide direct support to audits activities.

    For organisations that are going through mergers or acquisitions, or encountering new legislation, we also provide due diligence and integration support.

    Our goal is to help our clients build a self-sustaining quality culture throughout their organisations.

  • Minimising risk

    Organisations with strong Q&C processes are far less exposed to risk.

    We work with our clients’  drug development and commercialisation functions to minimise compliance risks, while recognising that the pace of drug development must remain unimpeded.

    Developing drugs quickly, while remaining fully compliant? With the right support, your organisation can achieve this.

Related think piece

How to build a Quality Culture

Quality and Compliance functions can be more than just valued business partners – they can be a competitive advantage. But, they have to work as part of a wider Quality Culture to be effective.

Your organisation needs to build a Quality Culture to achieve the highest levels of quality. Here’s how.

Learn more

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