CompliancePath is an end to end health and life science IT compliance and software validation service provider founded in the US in 2008. In 2018 the company opened a computer system validation and software quality assurance test centre in Glasgow, Scotland.
Life sciences and healthcare are highly regulated industries and any software used by companies operating in these fields needs to be validated for the intended use. In practice what this means is that when a company purchases software, such as Ideagen’s Q-Pulse or any other software application that impacts on patient safety or product quality, it has to be validated for the purpose it is going to be used for to ensure the company remains compliant with regulations. This can be a costly and time-consuming process and can become an unwelcome headache.
CompliancePath have been providing a fast-track, risk focused and GAMP based validation solution to the Ideagen Q-Pulse product for more than five years, significantly reducing cost and time to deployment for Q-Pulse customers. In addition, PleaseReview fast-track validation has been available for Ideagen customers since the beginning of 2020, with 90% of the validation activities being delivered remotely from CompliancePath’s Scottish test centre.
By working together Ideagen and CompliancePath can reduce the validation headache for companies through our proven and tested risk-based methodology that has been successfully deployed on more than 100 projects with Ideagen to date. Hugh Devine, MD of CompliancePath
Hugh Devine, MD of CompliancePath, explained: “It was a natural evolution to extend our risk based remote delivery of validation services to existing Ideagen companies. Most Life Science customers who are using Q-Pulse or PleaseReview will have several other software applications that will require validation to meet their regulatory requirements. Our extended partnership of additional professional services to cover all software related validation needs will allow Ideagen’s customers to continue to save time and cost while being able to utilise the remote delivery of validation. CompliancePath’s customers will now have a one stop shop to harmonise all their off the shelf (COTS) commercial validation projects.
Colin Smith, Head of Sales at Ideagen said: “This partnership with CompliancePath is hugely exciting for us. The work being done by health and life sciences companies is truly ground- breaking and it is great to know that we can take some of the administrative burden away from them. Allowing them to focus on their core work, while at the same time giving them the comfort and confidence of knowing that the processes they are following are properly validated and compliant with current legislation, is crucially important to us.”