How can we help you?

We design, deliver and manage simple, effective and robust QA solutions that are expertly aligned to your specific business needs.

We’re confident that the expert focus and care we provide to your business and users will be unmatched by any other provider.
It’sQA QMS has been designed by QA for QA based on research and it has been continuously certified to ISO 9000 by TUV since 2005.
Not being involved in any other clinical research activity enables It’sQA to provide a truly independent audit service with no conflict of interest.

Experienced and Independent Quality Assurance for Clinical Research

IT’s QA is a service company providing quality assurance for clinical research to the life science and healthcare industries. Whether you’re a large Pharmaceutical or a small Startup, we understand your industry.

Specialising in clinical research, we bring an unparalleled mix of business acumen and quality assurance expertise to work, in partnership, with you. Truly independent and committed to improving your business practice and procedures, we recognise the need for effective integration within your company.

Change can be a daunting prospect for many; employees can resist a changing culture if they don’t understand the benefits. Quality can be seen as bureaucratic. IT’sQA can help cut through the “red tape” and manage change proactively. We actively engage with your team getting buy-in and ensuring continuous improvement happens where it matters, at the heart of your business. For small companies, the financial burden and need for expert input can be a lot to cope with. That’s where IT’sQA All Day Every Day™ can really help.

Even for larger organisations, the audit schedule can be hard to manage internally. The extra work involved, planning and preparing for inspections can be considerable. Our dedicated team of experts is here for you, understanding your needs and providing solutions. IT’s QA brings drive and passion to what we do: after all, quality is our business.

Our clients include pharmaceutical, medical device, biotechnology, laboratory and software development companies.

GxP Audit Programme

It’sQA provides a comprehensive audit programme for all systems, processes and studies in clinical research including the interfaces with GMP, GLP, GVP and the validation and use of computer systems. Includes audits of vendors, laboratories, investigator’s sites, pharmacovigilance, data integrity, qualification etc.

QMS for Drug Development

We help organisations to establish and manage robust QMS processes and SOPs build for change and continuous improvement for the whole drug development process (GMP, GLP, GCL, GVP etc) to ensure consistent GxP compliant quality standards, traceability and inspection readiness.

Find your GxP consultant/auditor

We provide expert QA recruitment services to help organisations attract, evaluate, and onboard qualified Quality Assurance personnel.

Why It’sQA?

Because you need independent and experienced auditors to help you demonstrate the safety and efficacy of your product(s)
You want to comply with the GxPs (GCP, GLP, GDP, GVP etc)
You want a flexible solution tailored to your needs
You need someone to start ASAP
You do not want to spend time sorting across many CVs
You want to achieve consistently the same quality for you audit reports
You want to have only one contract, project management and auditing workflow procedure for all your staff in your company

It'sQA is a community

It’sQA is not a referral service nor a developer of computer systems.

We are clinical auditors, and the consultants are our colleagues, peers and friends.

Research, customer service and sustainable innovation are at the heart of It’sQA. We have been the first GxP QA consultancy to use the GLocal model in our industry in 2005. We found this was the most cost-effective and sustainable way to serve our customers with their need for international QA audits.

The local knowledge and language adds value to the audit whilst keeping air travel to the minimum.

Quality of deliverables is assured by our centralised project and account management from the small office in the UK.

You are global and local and so is It'sQA

Over the years, It’sQA has built a network of highly skilled, dedicated GCP auditors in all the continents of the world. We are present in more than 16 countries worldwide with a wide range of specialist areas, highly technical skills and even language capabilities.

From these bases, consultants have undertaken clinical quality assurance projects all over the world.

What’s it like to work with It’sQA?

It'sQA provided high quality trial-site GCP audits for us at very short notice. Their rapid and efficient work in auditing sites in the Ukraine allowed us to complete Due Diligence on a product acquisition within a very tight timeframe. They provided a highly effective solution when all of the major providers had failed to do so. I unreservedly recommend them for any GCP audit work.

We loved It'sQA and Piera's team! They responded to our needs really quickly and their work was done with the greatest attention to detail. This is the reason why we continue to use their services!

I am working with you since 2010. Since then, all my audit requests were adhered to without exception. As a main feature, you have shown very high flexibility to conduct business, even on very short notice. This is rather exceptional in this business. Auditors are well qualified and selected appropriately for the relevant audit. Quality of auditor's work is overall very good based on the audit reports received and outcome of co-audits.

You understand us and all reports are consistently good, targeted for our needs. This means a lot to us!

My staff and I would like to express our appreciation for the excellent work done by you during the visit.

Your cost structure is transparent and we can always find a way to meet our budget.

You have the ability to make people do things well …. this is a strength!

Dr Pierangela Sedda Ph.D

Dr Pierangela Sedda is the founder and head of It’sQA. As a member of the Research Quality Association (RQA) and the Institute of Clinical Research (ICR), she has worked in the pharmaceutical industry playing an important role in Quality Assurance since 1996 conducting audits across Europe as well as India, South Africa, South America and the United States.

Contact us

Talk to us to discover our range of services and let us manage your GXP Quality Assurance requirements for you.

ItsQA