Interview: Meet EXTEDO’s eDOCSmanager Quality powered by CARA!

Many well-known life science companies already rely on the performance of our products and services, so we decided to let them have their say. To this end, we have launched a series of interviews in which we hear from them directly about how they support our customers and what makes working with them so special.   

Join us for the latest part of our series, where we meet eDOCSmanager Quality powered by CARA. It tells us how its automated workflows facilitate accuracy in managing quality documents, describes its collaboration capabilities within an organization and why it likes to issue certificates via the training management. 

Welcome to our guest! Could you please introduce yourself and explain how you help life science organizations meet their regulatory requirements? 
Thank you! My name is eDOCSmanager Quality powered by CARA, and I am a part of the EXTEDOpulse team. My responsibilities include managing documents for quality purposes, such as Standard Operating Procedures (SOPs), but also processes like CAPAs (Corrective and Preventive Actions), audits, supplier qualifications, change requests, and recalls.  
I also support users by keeping track of their tasks and reminding them to complete their SOPs through my learning management system. This ensures that everything is documented accurately and transparently – essential for inspections or audits! Users can rely on me to keep all necessary data tracked and easily accessible. 

That sounds very useful. Can you explain how you make it easier for companies to comply with strict regulations like those from the US FDA and EMA? 
You know, regulations from the US FDA, EMA, and ISO standards require a robust quality system with specific processes. For example, supplier qualification involves a risk assessment and audit prior to approval. My system allows users to transparently track all observations and follow-up activities. I can send reminders for specific tasks and this transparency and reliability makes compliance much easier for my users. 

Speaking of transparency, how do you improve the efficiency and accuracy of managing quality documents? 
Thanks to my automated workflows, users collaborate seamlessly on documents without worrying about version control issues. All changes are tracked in one document, and I highlight differences with my compare functionality, not only for documents but also for data items. The workflow facilitates smooth review and approval processes, ensuring that the final document is accurate and up to date. Alerts remind users of pending tasks, keeping everyone on track. 

Great to hear! You also have a dashboard and KPI management features to help users stay on top of their compliance. Can you elaborate on how these are working? 
Absolutely. My dashboard provides an overview of the quality system's performance, showing key performance indicators (KPIs) like document statuses (draft, review, approved) and open CAPAs after audits. It helps users see if they're meeting timelines and if the workload is evenly distributed. This visibility ensures that compliance activities are always on track. 

You also handle training management. How do you ensure that your training management is compliant with regulations and streamline quality control processes? 
Training management is critical to compliance. I inform users when new SOPs are issued and require training. They complete quizzes to demonstrate understanding, and I track their progress. If they don't pass the quiz, I send them back to review the material until they do. Successful completion results in a certificate, which is documented in the system.  

And we all love certificates, don't we? 
Yes, we do! And I love issuing them. It’s always satisfying to see users earn their certificates and know they’re fully trained and compliant. 

That sounds very comprehensive. But still there are often other tools and systems in a company. How do you collaborate with them? 
I integrate closely with other tools and systems, e. g. one of my colleagues in the EXTEDOpulse team, Master Data Management. It is incredibly knowledgeable and plays an essential role in keeping product information up to date. For instance, if there's a complaint, I can access detailed product data from Master Data Management to provide accurate information. In regulatory activities, change requests are tracked through my system to ensure all actions are completed accurately.  

I also collaborate with regulatory colleagues, e. g., for activities linked to variations that require change requests. Together, we make sure that all processes are handled smoothly and compliantly. Sometimes, users need to remind their human colleagues about their tasks. I don’t have to - all my colleagues from the EXTEDOpulse team and I are well-connected. We know what's going on in each area. This teamwork ensures that quality management is integrated seamlessly across the organization. 

Thank you for sharing all this information. Before we wrap up, is there anything else you'd like to add? 
As managing corrective actions is a daily task for my quality users, I would like to add something about CAPAs. I support tracking, reminding colleagues of their tasks, and ensuring all quality processes are documented and followed. Because I am so flexible, I can contribute to various quality processes to support compliance in the life sciences industry. 

Now, if our readers would like to work with you, where can they find you? 
Well, of course I do have my own website with more information about me: eDOCSmanager Quality Module - A secure QMS for Life Sciences | EXTEDO. You can also contact your Account Manager if you already have one. They are always happy to help! 

Thank you, eDOCSmanager Quality powered by CARA. This has been a very insightful interview!! 

Would you like to meet another one of EXTEDO’s offers?    

Read the whole interview with EXTEDO’s eCTDtemplates!