Knowledge base
We share because we care
Podcast: AI in Quality Management
In this episode Chantal van Gorp (ION Pharma) and Josh Keliher (Ennov) will explore the potential and hurdles preventing adoption of AI in Quality Management.
Video: RIMS Implementation Roadmap
Discover the 9-step roadmap to implement a Regulatory Information Management System, from initiation to project closure, sharing tips and tricks for vendor selection, system design, implementation, validation, and training.
Downloads
Knowledge ready to download
QA Vendor Selection in the Life Sciences Industry
QA Vendor Selection
Discover best practices for selecting QA vendors in Life Sciences that support your QA goals, ensure regulatory compliance, and strengthen inspection readiness.
8 Roadmap Steps for a Successful eQMS Implementation
eQMS Implementation
How do you successfully execute your eQMS Implementation project in only 8 steps and how do you prevent common pitfalls? These and more tips throughout the implementation process are shared in this download.
How to prevent the main Project Management Pitfalls
Project Management
Getting your project delivered on time and within budget can be a real challenge. Be aware of these 4 major pitfalls that could make you exceed your budget and timeline and discover their preventive actions.
Extracting Your Application’s Data
Data Extraction
Do you know how you can extract your application’s data into a readable format and usable for migration? In this download we elaborate on our developed process of the 4 steps of extraction: Assessment, Extraction, Verification and Handover.
Assembling The A-Team for your Project Team
eQMS Implementation
Projects, regardless of size and scope, are often complex and are also always a group effort. But how do you select the right people for the right positions? This download elaborates on how to use the PACT principle to select those people.
Don’t miss these 18 User Requirement Categories
eQMS Implementation
System and process owners define User Requirements Specifications early in the process before a system is created or bought. With these 18 Key Requirement Categories you stay on track without missing one or more relevant requirements.
CSV Deliverables and their Interrelationships
eQMS Implementation
Prevent negative impact on Patient Safety, Data Integrity and Product Quality with Computer System Validation (CSV) and Computer Software Assurance (CSA). This download contains a deliverables overview during the CSV phase and the visualized interrelationships.
Blogs and Articles
Our views on industry topics
Pillars for a Killer URS – Balancing Users, System, and Business
Karianne Martel
26 April 2023
Many companies are struggling to define a solid User Requirements Specification for their new to implement system or process. In this blog, Karianne shares her experiences of defining user requirements for computerized systems and how she is able to hit the nail on the head by focusing on the pillars for a killer URS.
Creating a Robust Framework for Life Sciences Compliance with ISO27001, ISO9001 and GAMP5
Mabel Koolen
24 March 2023
The ISO27001, ISO9001 standards and the GAMP5 guidelines are vital for any business that prioritize protecting critical (information) assets, delivering high-quality products and services, and have to comply with regulatory requirements. In this article, we will delve into the reasons why we believe that these three frameworks are vital for creating a robust compliance framework in Life Sciences.
Personal Blog | Key Lessons Learned from my ISO27001 Recertification Experience
Mabel Koolen
10 February 2023
Information security is an increasingly important concern in today’s digital landscape. That’s why ISO27001 has become an increasingly popular standard for organizations looking to secure their information assets. In this blog, Mabel Koolen will be sharing her personal experience with ISO27001 in a small company and offering insights and encouragement for those who may be considering a similar journey.
Preventing Vendor Lock-In – Better Safe than Sorry
Sacha Richters
18 January 2023
Imagine you find that your eQMS processes aren’t efficient anymore and need an update, but your system can’t support you in executing the new and improved processes. When contacting your eQMS vendor for help with retiring the system the tells you that this is not included in the support. You have become a victim of vendor lock-in.
Avoiding Common eQMS Implementation Project Pitfalls: A Must-Read Guide
Chantal van Gorp
8 December 2022
The selection and implementation of a new electronic Quality Management System is a complex process. To ensure a successful transition, it is important for organizations to understand the potential pitfalls that may arise. In this article, we will look at five of the most common pitfalls that organizations should be conscious of when selecting and implementing an eQMS.
10 differences between GAMP5 1st and 2nd Edition
Chantal van Gorp
29 November 2022
In July 2022 ISPE released the GAMP5 2nd Edition. This guide embraces the new and progressive CSA approach for software validation in relation to the established CSV guidelines. But what are the differences between this first and second edition of the GAMP5?