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, Qualification and Validation
Our main goal is to achieve a quality product that is manufactured within your facility. We cover all aspects of commissioning, qualification and validation engineering including computer, equipment, process, cleaning and supply chain. Our consultants are on hand to ensure all aspects are covered including, VMP’s, URS’s, RTM’s, DQR’s, FAT’s, SAT’s, IQ’s, OQ’s and PQ’s.
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 ground up ISO 13485:2016 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
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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