Regulatory bodies such as the FDA require validation of software utilised to manufacture and distribute medical devices and pharmaceuticals. Detailed validation templates are available for QAD Enterprise Applications. We can manage and perform the validation services for your company eliminating the need to take employees away from their day jobs. Our consultants are qualified to develop your validation plan, perform a risk assessment along with your team and perform and document the IQ, OQ and PQ on your behalf.
Cebos MQ1/QAD QMS
QAD QMS uses an integrated system to automate, store and give access to written documentation and interactive processes such as CAPA and internal audits. It connects every department to one system. This makes communication fast and easy, eliminates the need for paper documents and cuts down the time to deliver, review and approve documents.
QAD QMS provides storage of all quality management system documentation in a single server location. Users can access documents and complete processes without paging through manuals, binders or paper files in multiple locations. Everything is accessible with a secure login and password.
The software enables teams to share, store and access information for the Corrective and Preventive Action (CAPA) process from the initial investigation phase to the final corrective action. Team members in remote locations can access documents, enter data and make changes from any location.
QAD QMS can track employee quality and process training and produce training report documentation. It can send automatic reminders to participants and collect feedback after course completion.
QAD QMS can be used to store audit check sheets and audit results. It can produce reports, document non-conformances and produce corrective and preventive action documentation. Teams can use the audit software to input audit data and review reports.
Our Consultants can recommend and implement the appropriate modules/functionality for your business.
For a summary of each module available in the QAD QMS suite, here is a summary on the QAD website.
Regulatory Attributes help companies meet various regulatory and industry compliance requirements, for example: current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR), NAFTA and GATT. Regulatory Attributes enables manufacturers to associate customers, items or sites with regulatory agency codes for import/export and international agreement compliance. It helps reduce compliance risk by applying regulatory controls at the batch and lot level enabling cradle to grave lot traceability and work order tracking and meet specific industry and governmental regulatory requirements, for example: track regulatory agency licenses like the DEA, support controls required by cGMP and provide for the use of eSignatures.
Our Consultants can help you implement Regulatory Attributes to meet your compliance needs.