Before you build a Quality Management System (QMS), it’s critical that you understand what is your key driver.

What you should ask yourself before building a quality management system

Posted on Posted in Confluence, Electronic QMS, JIRA

Before you build a quality management system (QMS), it’s critical that you understand what is your key driver. Over the years, here are some of the motives I’ve heard:   It’s a milestone for the next funding round. It satisfies regulatory requirements (i.e. CE mark, FDA approval). We’re “forced” to have one. We’re about to […]

Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. The trick is to strike a balance in the content, style, and organisation so they're easily understood by anyone who reads them.

Four strategies to ensure your standard operating procedures are easy to read

Posted on Posted in JIRA

Standard Operating Procedures (SOPs) are necessary for any efficient system, and yet their effectiveness can vary widely based on how well – or not – the procedures are written. Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. […]

Validating JIRA (or what we can learn from the use of Excel in regulated life sciences organisations)

Validating Jira

Posted on Posted in Electronic QMS, JIRA

(or what we can learn from the use of Excel in regulated life sciences organisations) Jira seems to be installed everywhere now. Typically, it begins with a grassroots initiative then its usage spreads almost virally, until a mid-level or senior executive realises that it has become essential to the running of the business. In life […]

Managing a life science company’s training records is notoriously difficult. Wouldn’t it be great if training could become a routine part of the way your team works, and if your training matrix and training record could be generated automatically? Well now all this is possible, with help from JIRA Core and RadBee.

Managing training with Jira

Posted on Posted in JIRA

Managing a life science company’s training records is notoriously difficult. Wouldn’t it be great if training could become a routine part of the way your team works, and if your training matrix and training record could be generated automatically? Well now all this is possible, with help from Jira Core and RadBee. Watch this video […]

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 […]