The practice of software validation is a distinguishing characteristic of the life sciences industry. The FDA requires any software that touches the regulated process to be validated. This software must be tested and managed in a way that demonstrates its performance as intended by the end user.
Software validations serve an important purpose in Life Sciences Industry - ensuring that the software being used to maintain Part 11 records do so, with accuracy, reliability, integrity, availability and authenticity. However, life science companies validating software against 21-CFR-Part 11 are aware about how resource intensive validation can be.
- We have a dedicated team of validation & compliance experts with a proven and methodical approach to systems validation that saves your time and resources, thereby reducing the high costs associated with validation
- Our validation products and services specific to the Oracle Health Sciences application suite can offer custom validation services that are tailored to fit your organization's needs, including quality systems gap analysis and third party user acceptance testing
- Our validation experts can prepare a range of requirements for validation process, from Validation plan to Validation summary and help in IQ/OQ and PQ process and documentation. We also have validation accelerators through which the documentation process can be speeded up and compliance with Computer system validation guidelines and 21 CFR Part 11 guidelines can be achieved