In CompuCal we have been working on the development and testing of software for regulated industries for over 25 years. We know that the documented validation of the software is a requirement for compliance with FDA, FSMA and other relevant regulations.
We reviewed the report of the 483 FDA forms for the fiscal year 2018 and we present you the most common calibration related observations by industry.
One of the most critical figures in the effective management of data center operations is the PUE. A calibration management software can help you reduce it.
Although IoT hasn't been used yet to its full potential, it has come to stay. The benefits of IoT technology in the prevention of food contamination and cost decrease are multiple. Find out how it can be used in food industry.
During the last years, the global temperature has increased and a lot of regions experience warm and dry weather. This is a threaten to beer production. Read the reason in this article.
Are you in compliance with FSMA? Here there is a high level presentation of the Food Safety Modernization Act in simple terms with links from FDA's official page.
A very common question among calibration technicians and operation managers is the frequency of calibration. When should you calibrate your instruments?
Instrumentation is an indispensable part of any production unit. If you don't calibrate then you have no idea whether your instruments are giving the right readings to your control or batching system.
Packaging may not be the first thing that pops into your mind when writing up your calibration SOP, but it is critical in the process of effective and controlled calibration management.
What is your estimation on the cost of a warning letter for your business? Find out which areas are affected if your company receives a warning letter from FDA.
