Why waste reduction is the #1 priority for QA & Compliance, according to experts

Posted on Posted in General

At a recent knowledge sharing and networking event in London, England, life science industry professionals gathered to glean insights from experts on the common challenges experienced in implementing effective quality systems. While there were many important points made, the one consistent takeaway was that the key to practical QA and compliance is the reduction of waste. This […]

Survey says: Proactive quality risk management for life science companies is a must

Posted on Posted in Electronic QMS, General, london_2018

Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their compliance obstacles into real business opportunities. The practical aspects of this vision are as important to regulatory bodies as they are to the companies Epista serves. To get clear on […]

An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork. Beyond the risk of non-compliance, it was a daily challenge to ensure that procedures were standardised and the latest documents were being referenced.

How we Saved a medical device company time, compliance headaches and money

Posted on Posted in Case studies, General, JIRA

For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance.  The challenge  An in […]

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 […]

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 […]

Good practice dictates that controlled records should be managed in compliance with the FDA CFR 21 part 11 (aka Part 11) guidelines.

Adjusting Jira for FDA CFR 21 Part 11 compliance: managing deletion

Posted on Posted in JIRA

Regulations dictate that controlled records should be managed in compliance with the FDA CFR 21 Part 11 (aka Part 11) guidelines. Part 11 defines the criteria under which the US Food and Drug Administration ‘considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records […]

Why the controlled document lifecycle matters

Why the controlled document lifecycle matters

Posted on Posted in Confluence

Often, when life sciences companies are working to define their controlled document management process, they spend a lot of time considering the regulations and ensuring that their approval process and electronic signatures are compliant. However, the regulations don’t require the process to be easy or efficient, and prioritising compliance over practicality often results in cumbersome […]