Compliance and validation

- Ensure compliance in your systems and processes.

 

Compliance and quality are important to all processes and system implementations in Clinical Development. HERAX provides a series of validation services to support daily operations, as well as in relation to projects and offers a full range of compliance advisory services, from revision of existing documentation, development of new SOPs to compliance evaluation in implementation projects.

Quality Documentation in IT validation and compliance

Areas within compliance and validation

IT Validation
HERAX provides all validation services by following a risk-based approach in compliance with GAMP5, CFR part 11 and ISO13485.

Vendor Audits
HERAX has experience with IT vendor audits, evaluation of QMS quality and adherence, SDLC evaluations and service provider audits (both IT and CROs).

GxP/GDPR Compliance
Ensuring that new systems and new processes adhere to Good Clinical Practice and GDPR is a specialty of HERAX’.

How can we help?

Ensuring compliance without unnecessarily complicating your processes and documentation or extending project timelines can be difficult but is a challenge worth facing. At HERAX we can help you find the right level of IT system validation based on our extensive experience with risk-based IT validation. When assessing a new vendor, the use of our standard audit tool ensures that all regulatory and compliance areas are covered. Our consultants have extensive knowledge about GCP, Quality and Compliance and can assist with these services in all areas of Clinical Development. All our validation services are based on GAMP5.

Industry experience

We know Pharma. And that is not something we're just saying. Our consultants have extensive knowledge with Pharma or has an education within biotechnology. This also means that we know your business and the obstacles there can be when ensuring that you are compliant, or making sure your new systems and new processes adhere to Good Clinical Practice and GDPR. 

Quality of work

At HERAX we pride ourselves in being some of the best in the Life Science industry. This is not something we just say, this is proven by our consultants and their knowledge. Over time, with the right people and services, we have proven to be one of the best consultancy companies, by being chosen by some of the biggest Life Science companies in the world. We aim to bring quality and value to your company. 

Working with us 

We support you every step of the way. We work with you to add value, knowledge and resources to your projects, whatever your needs may be. Our methodology and work ethics ensure that you get IT projects implemented on time and budget, with the right level of quality and compliance.

Our experts are always ready to talk to you. Find Sophie's contact information below or get in contact with us through the contact form to the right. 

 

Sophie
Sophie Hytteballe
Senior Project Manager

Phone+ 45 3049 6800

email shy@herax.com