Quality Assurance and System Validation

We believe in delivering GxP compliance, precision and legibility, developing your corporate governance documentation in conjunction with your needs to ensure it feels like your own.

  • Implementation support
  • Best practice
  • Compliance review
  • Systems validation

Our RQA-qualified consultants offer comprehensive Quality Assurance (QA) and Quality Management Systems (QMS) consultancy, particularly in the context of Computer System Validation (CSV).

Systems implementation support

Our extensive experience implementing SCEs and other validated systems at both CROs and major pharmaceutical companies guarantees your solutions and platforms are implemented efficiently and seamlessly. Our services include:

  • Providing qualified systems engineers
  • Designing end-to-end platform implementation
  • Providing support on in-progress projects

Here we assist with creation of a project outline and implementation plan, offering support throughout and ensuring a comprehensive sign-off and handover upon completion.

Best Practice Advice

Even when your QMS is fully compliant with relevant regulations, we offer guidance on streamlining and optimization drawing on our extensive experience in the life sciences sector.

  • QMS streamlining advice
  • Future-proofing standard operating procedures

Though we can come in at any point during your project timeline, we work best advising from the start or reviewing your written work at the end.

Ensuring GxP compliance

Our QA expertise is built on decades of work in the life sciences sector. Our consultants can help you ensure full GxP compliance with ICH E6(R3), MHRA GCP (2012), SI 2004/1031, and Directive 2005/28/EC.

  • Compliance checking service
  • Advice from fully qualified experts
  • Full documentation review

Whether your project is already underway, about to start, or already finished, our consultants can review your procedural compliance at any stage.

Quality Management System review

Whether you need a full or partial review of your Quality Management System, or prepare for an upcoming regulatory audit, we offer comprehensive reviews of your documentation and processes.

  • Validation for GxP systems
  • Regulatory audit preparation and support

Computer Systems Validation (CSV)

Focusing on proving that your systems and processes consistently produce results meeting predetermined specifications. It is especially critical in environments that rely on complex manufacturing processes and stringent regulatory requirements, and we offer expert advice on validating your systems.

  • Design and Installation Validation
  • Operational and Performance Validation
  • Change Control and Re-Validation
Help Center

Questions? Answers.

Quick answers to questions you may have. Can't find what you're looking for? Check out our full documentation.

This depends on the scope of the project, approval of the statement of work, and availability of our consultants. Generally, we can begin projects between two weeks and a month from your initial enquiry.

The principles of our pricing strategy are to be transparent and good value for money. As such we adopt a simple pricing model that incorporates:

  • for Fixed Price projects, a clear statements of tasks to be completed, work required per task and daily rates for each level of contributor to the project.  

  • for Time Based assignments, a transparent pricing model based on level of consultant and duration and intensity of the commitment required

Please contact us for an indicative quote

A brief overview of some of our past solutions can be found on our Solutions page. If you'd like more details on any of these, please contact us for a brochure.

You can send us a request for consultant profiles. Please make sure to provide project details so we can send you the relevant profiles.