Research & Development
Create A Lean Quality Assurance System For Your R&D Processes
In the area of research and development we support our clients by conducting Quality Assurance studies. The purpose of these studies is to analyze our client’s Quality Assurance System.
A major goal of this analysis is to enable the creation of a lean Quality Management System (QMS), which ensures that all relevant data and procedures required by a specific client are in place. An example of such a procedure could be the registration activities required for various purposes by the client.
Further major activities focusing around the development process could include the following:
FDA Registrations / 510(k)
We provide support to our clients in the preparation of the documentation required for FDA registrations such as 510(k) and premarket approvals (PMA). Our teams review the documentation of such submissions for their completeness and accuracy; we supplement this documentation wherever necessary.
Design History And Site History File Creation
We are able to analyze our client’s documentation and the procedures used to create these documents. Should GxP-CC identify any gaps in the documentation and/or the procedures for document creation, we can provide the necessary know-how to create a more suitable documentation for submission to European, American or other regulatory authorities.
Method and System Validation is one of the key success factors for providing reliable documentation for drug development and drug registration.
Method And System Validation
Method and System Validation is one of the key success factors for providing reliable documentation for drug development and drug registration. Our experts provide support in the following areas:
- Validation of analytical methods
- Validation of laboratory and pre-production equipment
- Validation of software (e.g. Statistical Software)
All of these services are supported by our experts who conduct a detailed “as-is” analysis and a client-tailored solution approach. Templates and generic SOPs for a wide range of topics can be provided to allow a “fast-track” start for the activities requested by our clients.
We can also provide training and procedures for self-inspection in order to assure a consistent and reliable implementation of any improvements we would suggest or recommend to our client during the course of a project.
Supportive Tools To Assist With The QMS Process
Many of the activities may be supported by a variety of tools (e.g. Electronic Document Management Systems, Laboratory Information Management Systems and others). Our experienced and specialized procedures aid our customers in identifying the right solution for their needs and requirements.
We provide a range of services beginning with the initial evaluation to the specification, implementation and validation phases in projects designed together with our clients. Based on your exact needs we can provide partial or complete services for the implementation of any of the abovementioned services.
Get the expert help you need to create a lean QMS. Contact Us About Research & Development Solutions