GxP Compliance Software
Cloud-based, GxP compliant QMS software that helps you ensure compliance with the current GxP requirements.
GxP compliant software system designed for life sciences
The term GxP is generally used to describe good practice guidelines within the pharmaceutical industry. By definition, GxP includes a variety of regulation guidelines but the most common are GCP, GLP, and GMP. A GxP software like SimplerQMS offers a smart digital solution that can simplify your work and help you reach your QA/RA goals more efficiently.
The main benefit of GxP software for your business
Since GxP defines a broad collection of regulatory guidelines for the pharmaceutical industry, it requires a capable GxP software that can handle all requirements. SimplerQMS GxP system allows you to manage your trial master files and commitment, directive, or data collections documents with ease and simplicity.
Interlink all your quality processes
When it comes to the practical management of these documents, you can interlink them with the GxP software and achieve an even smoother workflow. Link your trial master files to specific projects and related documents to always have access to them and all their past changes within a few clicks. You will be able to:
Seamlessly achieve full traceability
Quickly locate and resolve root causes of problems
Have your files accessible from any location
Allow the system to send automatic notifications for tasks, training, calibration, etc.
Better prevent human error and save resources
Automate your training management processes
When new training materials are released The training management module will automatically notify your employees. The SimplerQMS GxP Software also offers dashboards with which you can monitor the training activities of each team member and remind them about certifications that are about to expire. The DEMO video practical demonstration of the module, take a look.
Utilize trusted technology platform
M-Files technology forms a foundation of the SimplerQMS GxP software. M-Files develops a document management platform that is currently used by 5000+ customers all over the world. Full integration of M-Files with Microsoft office, salesforce, azure, and many more 3rd party applications provides several benefits. One of them is the possibility to edit and save documents seamlessly within Microsoft office without the need to download and upload them to your eQMS GxP Software.
Automate document management processes
The document control module automatically numbers, versions, and names your documents. Then you can enforce the usage of your standardized and approved forms within the GxP software. It also allows you to work in a familiar Microsoft Office environment, as well as restrict access to the documentation so that only specific team members can view it. Lastly, you can automate workflows so that your employees are notified about pending tasks, signature requests, and more.
Fast implementation, pre-validated software
The SimplerQMS GxP Software is a pre-validated solution. In practice, this means that we will deliver a solution that can be used right after the implementation. In addition to that, we re-validate the GxP software every month to ensure compliance. Finally, we value your time. For that reason, we use an incremental implementation process that on average takes 5-6 weeks and places little strain on your current processes and organization.
Streamline your CAPA processes
With the SimplerQMS CAPA Management Module, you can analyze data via built-in dashboards and identify patterns to easily understand which components of the system are affected by the deviations. Get an overview of CAPA-trending, easily export post-market surveillance data, and track the performance of your employees towards due dates. Enjoy an out-of-the-box, closed-loop CAPA process that allows you to analyze any quality issue from any location.
Fast and easy audits
Enjoy shorter preparation for audits, no missing documents, and fast search for requested documents. The audit management module lets you easily link NCRs, SCARs, or CAPAs or securely share important documents with notified bodies or external parties. Collect all upcoming audits under an audit plan, escalate investigation of high-risk activities and seamlessly track low-risk findings.
What customers achieve with SimplerQMS
Utilize proven technology
SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.
Pass audit more easily
Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.
Gain a high level of traceability
Gain cross-functional visibility and trace back to the root cause of each nonconformance.
“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”
Frequently Asked Questions
What is GxP?
The term GxP is generally used as a summarizing term for all good practice guidelines within the pharmaceutical industry. By definition, GxP includes a variety of regulation guidelines but the most common are GCP, GLP, and GMP.
What is GxP software?
GxP software refers to an electronic quality management system (eQMS) that complies with the GxP guidelines.
What does GxP stand for?
The short answer would be that GxP stands for Good X Practice. The X then represents a variable that specifies the exact Good Practice guideline. A few examples, GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), etc.
What is GxP cloud compliance?
GxP cloud compliance simply asks the question of whether specific cloud storage complies with the GxP guidelines. Often this is not the case and there needs to be GxP software built on the top of the cloud storage to assure GxP compliance.
What is the difference between GxP and GMP?
GxP is a term that covers all good practice guidelines. GMP on the other hand is a specific good practice guideline that focuses on manufacturing practices.
Ready to learn more?
To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.
