Before, FDA (Food and Drug Administration) puts heavy emphasis on documentation, which makes it hard for businesses to transition from paper-based to automation and technology-based methods. Nowadays, FDA has seen the importance of computer software for quality management rather than the paper-based methods, releasing the new FDA validation guidelines in effect.
Quality management software improves the business’ data integrity (FDA), is easier to track, gives businesses a better product performance knowledge, optimizes the processes, allows businesses to respond promptly, provides better patient experiences, reduces product risks and operational expenses, and most importantly, increases the business’ value.
IT consultants in Bridgewater, New Jersey, recommends that you have the following requirements ready at the time of validation:
- Installation Qualification (IQ)
The software must be installed correctly, free from cyber security threats. As FDA puts it, “establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer’s recommendations are suitably considered.”
- Operational Qualification (OQ)
This ensures that the product will be able to meet the users’ needs. FDA puts it this way, “establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and duly considering the manufacturer’s recommendations.”
- Performance Qualification (PQ)
The FDA defines PQ as “establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.” This then ensures that having installed the software, the product operates to its fullest functions properly.