Information System
Compliance Solutions

ABOUT US
IS Compliance Solutions is built on decades of experience in information systems consultancy, gained predominantly within the highly regulated GxP life sciences sector. Our work spans the full spectrum from supporting individuals and small companies with straightforward compliance needs, through to partnering with large global pharmaceutical and medical device organisations where we are embedded deep within complex business critical programmes or leading major projects.

We are at the forefront of digital validation and AI‑enabled operational management, breaking new ground in how compliance can drive innovation, efficiency, and sustainable transformation. Our knowledge and experience rank among the best, enabling us to deliver precisely what is required, no less, and often far more than expected.

Services

Validation

Computer Systems Validation is second nature to our business having established ourselves within the industry over 25 years ago. We can provide advice, consultancy, management and of course hands-on validation for IT, OT, cloud based solutions and now Artificial Intelligence

Project Management

Our Project Management service offers comprehensive solutions to efficiently plan, execute, and monitor your projects. Our PM's have the qualifications but more importantly vast experience in delivering projects for life sciences companies where quality is as important as the timeline and budget

Quality Management Systems

Whether your starting from scratch or looking to enhance or improve your current QMS or eQMS we can help with our significant experience of design, implementation, validation and auditing of such systems. we'll happily work with paper based systems however our specialty is in digital solutions where we can support you at every level.

Digital Transformation

If you have a need but are not quite sure how it is to be achieved or even if it can be, speak to us as we can do the investigation and come back with solutions for your consideration, and don't be worried just like building blocks we quite often see a simple and cost effective option can be the best one!

Cyber Security

Working inline with ISO27001 we can implement a full information security framework as well as identify and assess your information holding assets for risks, vulnerabilities and cyber threats.

Operational Quality Management

Operational Quality Management is essential for maintaining your company in a compliance and audit ready state, whether you engage us to deal with a specific task or engage our managed service known as Compliance as a Service (CaaS) we will effectively plan, execute, and measure your operational quality activities from that initial start up and beyond meaning you can focus on your great ideas and products.

Compliance as a Service - CaaS
CaaS is a scalable solution that delivers continuous compliance support tailored to your organisation’s needs. Whether you're a start-up navigating your first regulatory obligations or a mature enterprise seeking to streamline quality operations, CaaS provides structured oversight, actionable insights, and hands-on expertise. It’s not just about ticking boxes — it’s about building a culture of compliance that evolves with your business. From system validation and QMS implementation to risk management and audit readiness, our team becomes an extension of yours, ensuring that quality and compliance are not reactive events but embedded capabilities. With CaaS, you gain access to our proven methodologies, digital toolkits, and decades of experience all delivered with the flexibility and responsiveness of a service model designed for modern regulated environments.

Testimonials

     

 The team at IS Compliance Solutions not only understood our needs when it came to the design of a QMS and implementation of an eQMS but they always took extra effort to explain the process involved and the reasons for taking such an approach. 

Jonathan B: Director of Quality
     

 Simon then went on to perform a thorough internal audit of our production facilities, leading to a range of non-conformances of process and systems (relating to GAMP compliance). Simon then went on to develop detailed processes, templates and training materials which enabled the firm to begin to address the findings of his audit. Latterly this was enabled the firm to effectively close out audit findings with its Notified Body. 

Chris H: Global QA/RA VP