Industry challenge
Ensuring the accuracy and consistency of laboratory data so that it complies with regulations like FDA 21 CFR Part 11, GLP & GMP, is a challenge for many organisations. When using a paper-based system, development, version control, approval and distribution of SOPs and worksheets are open to errors, and manual data searching/documentation is extremely time consuming.
When working in an on-site digital environment, security is a great issue, as healthcare and pharmaceutical databases are increasingly subjected to cyberattacks. Moving to the cloud is a great solution, as this not only means that the provider is responsible for security, but also allows for the recovery of files.
The cloud also provides the ability to scale up easily, removing the ceiling imposed by on-site storage. Lastly, it supports data-intense research and development.
Introducing the correct electronic system reduces the burden of complying with the applicable regulations, prevents the reporting of invalid data, and makes better use of laboratory resources.