cGMP Compliance Software
All-in-one quality management software that helps you ensure compliance with the current good manufacturing practices (cGMPs).
Component of cGMP software that can help your business
When it comes to cGMP compliance one of the most critical components comes down to quality control. With cGMP compliant software, you can quickly find your SOPs, deviations, out-of-specification documentation, and more within a couple of clicks. If any mistakes were to occur, full traceability of the cGMP software will allow you to track the root causes of the problem and solve them before they cause further damage.
SimplerQMS provides cGMP software that can help you strive towards efficient and straightforward quality assurance.
Interlink all your quality processes
With the cGMP software from SimplerQMS, you can connect processes and products to documents, easily integrate quality management processes, or view all past changes to a document in a few clicks. In practice our cGMP system software allows you to:
Work in a fully traceable QMS
Find out how each change affects other documents
Safely access your files from any location
Automatically remind employees about their tasks, training, calibration activities, etc.
Decrease the chance of human error and save time
Streamline your training management activities
The training management module of the SimplerQMS cGMP program automatically notifies employees when you release new training materials. You can also use dashboards within our cGMP software to view training activities by process, person or document. Furthermore, the software reminds employees and managers to renew their certificates before they expire. This DEMO video will allow you to get a deeper look at how could you reap these benefits in realistic scenarios.
Trusted technology platform
The core of the SimplerQMS cGMP software is formed by the M-Files Technology. M-Files is an intelligent document management platform with 5000+ customers worldwide. Thanks to this technology we are able to provide fully integrated cGMP manufacturing software. In practice, this means that you will be able to work in a familiar environment such as Microsoft Office and save documents with one click, instead of constant downloading and uploading.
Streamline your document control processes
With the SimplerQMS document control software module, documents are automatically versioned and numbered. You can set access rights for each document and make sure that only specific employees have access. The function of standardized and approved forms will then allow users to seamlessly draft new documents based on your customized forms. Finally, the automated workflows will notify specific people about pending tasks or requests for approvals or signatures.
Fast implementation, pre-validated software
Our cGMP software arrives at your company fully validated. In practice, we validate our software every month to ensure a high level of compliance, so that you don’t need to spend time and resources on software validation. Furthermore, to ensure that you can use your time effectively, we spent a lot of time on the design and development of our implementation process to remove all possible bottlenecks. Currently, we usually implement our cGMP compliant software within 5-6 weeks.
Facilitate your CAPA management processes
The SimplerQMS CAPA Management module can help you easily determine the root causes of your deviations or non-conformances. You can easily identify which components of the system were affected, identify patterns, and analyze the problem at different levels. Furthermore, the module allows you to keep track of possible areas of concern in real-time so that you can fix issues before they become a reality.
Fast and easy audits
With the audit management module, you can enjoy the efficiency of fast search for the documents requested by your auditor, convenience of no missing documents, and overall spend less time preparing for audits. Simply link NCRs, CAPAs, or SCARs to the audit findings and seamlessly and safely share documents with 3rd parties and auditors. Access your files from anywhere and have the possibility to attend remote audits while always knowing that you can find your documents and reports in a single location throughout the product lifecycle.
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 cGMP compliance?
cGMP is a short term for current Good Manufacturing Practice guidelines. CGMP is a term used by the FDA to refer to the newest and most up to dates manufacturing guidelines that need to be complied with when it comes to the manufacturing of your products. CGMP compliance then stands for a QMS that complies with such current good manufacturing practices.
What is the difference between GMP and cGMP?
Compliance with GMP means that a company complies with the minimal manufacturing practices applicable to the industry. cGMP on the other hand refers to a consistent and proactive following of the newest guidelines and recommendations which are then applied to the company’s manufacturing system. In conclusion, cGMP compliant companies always follow and comply with the newest guidelines.
What is cGMP software?
CGMP software is an electronic quality management system software that complies with the current Good Manufacturing Practice guidelines and allows you to handle your documentation in such a way that is cGMP compliant.
Ready to learn more?
To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.