How to validate computerised systems used for GxP and Medical devices environments. Computers system validation in an Agile age

Posted on Posted in General

8 February 2018, Stuttgart, Germany (9:00-17:00m)Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany In an age where computerised systems make the difference between winning and loosing, we need to find ways to continuously and relentlessly innovate our systems.  Today, compliance is no longer enough: we need a validation framework which helps the business move […]

RadBee Sophia Genetics Case Study

From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks

Posted on Posted in Case studies, Confluence, Electronic QMS

An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict regulatory and compliance requirements could mean lost business or even a complete shutdown of operations. The challenge Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of […]

Process mapping

Posted on Posted in Validation microsite

Whenever a new computer system is introduced or an old one updated, the goal is to better support one or more processes. For example, a document management system facilitates the process of authoring and approving documents while a service desk application streamlines the process of receiving and handling support requests. Before embarking on any project […]

Why you should manage your requirements in Jira

Why you should manage your requirements in Jira

Posted on Posted in Electronic QMS, JIRA

Many of my customers are devoted fans of both Jira and Confluence. They use Jira for tracking their development tasks, defects, and often times some of their business processes. For documenting technical specifications they’ll commonly use Confluence. I am also a fan of both applications, but when it comes to managing requirement specifications within a formal […]

How to validate Software Development tools used for GXP and MedDev?

Validating software development tools used for GxP and MedDev

Posted on Posted in Confluence, Electronic QMS, General, JIRA

Compliance is a key consideration when using software tools in the context of: Development of software applications which are used for good practice (GxP) purposes Development of software and hardware embedded on medical devices (MedDev). Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like […]