Validation is a process in which evidence on improvements made to processes are documented. It also ensures you meet pre-determined specifications and quality attributes, and provide evidence that in turn you are adhering to the correct standards. Lean is the never ending efforts to eliminate or reduce any activity that consumes resources without adding value.
Zenith Technologies’ validation specialists take a lean, practical, and science based approach to validation. By building upon existing industry good practices in an efficient and effective manner, we offer a robust, cost effective method to achieving computerised, process, utility, facility, IT business, and laboratory systems that are fit for their intended use and that meet current regulatory requirements.
Zenith Technologies approach to lean validation is adapted from the ten guiding principles of the Shingo model, and has been influenced by the ASTM E250 standard and the ISPE GAMP 5 guide. It is also based on many years of experience in industry.
The International Society for Pharmaceutical Engineering (ISPE) published GAMP 5 guidelines in 2008. It provides guidelines to develop and maintain automation systems in regulatory industries.
Benefits of Implementing a Validation Solution with Zenith Technologies:
- Document system control and compliance
- Optimise quality with efficiency
- Reduce the waste in your processes
- Provide evidence that you are working to industry standards
- Exceed Good Automated Manufacturing Practices (GAMP 5)
- Reduce the risk in your processes
Enterprise / System Integration
Zenith Technologies is a world leading enterprise integration company specialising in integrating Automation, Process Control and MES projects globally to Life Science customers.Read More...
Commissioning and Qualification
Ensuring the commissioning and qualification process runs smoothly and that systems are ready for handover is critical to project successRead More...