Validating Calibration Management Software for 21 CFR Part 11 is a pain, but with the right mind set the process can be speedy and beneficial. Given some trade tips and good advice there is an easier way to plan, construct and execute a validated compliant management software for the pharmaceutical and medical world of metrology.
Choosing Calibration Management Software
Lab and quality managers are forced to wear several different hats when choosing software for their business. Labs that have the resource of an IT department or an employee that has some software experience get frustrated trying to sift through the software maze and give up (more often than not). They decide the only way they are going to get what they want is to build it themselves. This fix is far from simple and will leave you wishing you bought a predesigned system.