Quality & Validation

Our quality experts ensure that all structured quality systems meet validation requirements in a way that works for you.

Working hand in hand, our quality experts and validation consultants work seamlessly to ensure the implementation of straightforward, compliant and structured quality systems that work alongside your validation requirements. 

Generally, both quality and validation are reviewed independently. However, when viewed together it allows for a more effective solution for our clients.

Our Expertise

Change Management

We can provide bespoke turnkey solutions or assist your exciting team through the process of change management.

CAPA and Deviations Management

CAPAs and Deviations are always a hot topic. Although mostly discussed hand in hand, our experts will ensure that you are equipped to handle any deviations with overarching CAPA management in mind. From system development to subsection closure, our team is on hand to assist.

Commissioning, Validation and Qualification

Our main goal is to achieve a quality product that is manufactured within your facility.

We cover all aspects of commissioning, validation and qualification including computer, equipment, process, cleaning and supply chain. Our experts are on hand to ensure all aspects are covered including, VMPs, URSs, RTMs, DQRs, FATs, SATs, IOQs and PQs.

Data Integrity / Data Governance

We will help design a data governance policy that is positioned to mitigate any compliance risk and ensure that data is managed in a way that is effective and transparent to the facility.

Quality Management Systems

From the implantation of a QMS system, through to the overhaul of an old system, we can help you ensure that the review process and management of critical documents is done in a compliant manner, and find the right way to introduce a workable solution into your business. 

  • Change Management

    Change Management

    We can provide bespoke turnkey solutions or assist your exciting team through the process of change management.

  • CAPA and Deviations Management

    CAPA and Deviations Management

    CAPAs and Deviations are always a hot topic. Although mostly discussed hand in hand, our experts will ensure that you are equipped to handle any deviations with overarching CAPA management in mind. From system development to subsection closure, our team is on hand to assist.

  • Commissioning, Validation and Qualification

    Commissioning, Validation and Qualification

    Our main goal is to achieve a quality product that is manufactured within your facility.

    We cover all aspects of commissioning, validation and qualification including computer, equipment, process, cleaning and supply chain. Our experts are on hand to ensure all aspects are covered including, VMPs, URSs, RTMs, DQRs, FATs, SATs, IOQs and PQs.

  • Data Integrity / Data Governance

    Data Integrity / Data Governance

    We will help design a data governance policy that is positioned to mitigate any compliance risk and ensure that data is managed in a way that is effective and transparent to the facility.

  • Quality Management Systems

    Quality Management Systems

    From the implantation of a QMS system, through to the overhaul of an old system, we can help you ensure that the review process and management of critical documents is done in a compliant manner, and find the right way to introduce a workable solution into your business. 

Our Other Services

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Consultancy

Our consulting team is on hand to provide you with expert advice within the life science sector to ensure that all of your compliance challenges are dealt with in an effective and proactive manner.
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Project & Cost Management

Our proactive project management team is positioned to ensure that all aspects of your dedicated project delivery are extensively planned, monitored and controlled.
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Resourcing

Having a keen eye on developing the correct culture within a business and the respective departments or resourcing team will add a huge support network that you can rely on when things are moving quickly.

Let’s Talk

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