Software Validation & Data Integrity Audit
The integrity of data generated by business software systems is an essential part of business risk
management. Additionally, the Food and Drug Administration (FDA) expects that all data associated
with regulated products will be reliable and accurate throughout the data life cycle.
Data integrity is generally part of a software validation effort to ensure the adequacy of access controls,
audit trails and electronic signatures, and good documentation practices. Also, the protection of
regulated data must be ensured by deploying procedures. Data integrity encompasses the accuracy,
completeness, and consistency of GxP data over its entire life cycle. It involves defining all the steps for
practical management, control, and documentation.
A data integrity audit will review compliance documentation related to the following:
- Security & access control
- Change Control
- Disaster Recovery Planning
- Audit Trail Integrity
- Documentation Practices
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.