The Life Science industry is increasingly becoming dependent on information communication technologies. Due to high and increasingly extensive demands for documented Quality Assurance efforts, these companies must ensure both data security and integrity by conforming to regulations such as the FDA CFR 21 Part 11 and GxP.
Regulatory authorities push the implementation of FDA CFR 21 Part 11 and GMP in the Life Science environments to enable fully electronic regulatory submissions, encouraging a faster and more accurate approval process while enabling full control of the processes.
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