CSV is mandatory for implementation of software systems in a GxP regulated environment. And, it would incur huge costs if not handled adequately.
With increasing number of software systems implemented in any organization, it becomes utmost important to check the costs at every step, especially of CSV.
The CSV tools include the following:
Mandate!
- To protect public health, safety
- To ensure consumers access to safe, effective, affordable medicines
How?
- Regulations
- Guidance documents
- Regular inspections
- Enforcing actions
Today…
- GMP violations & non-compliance
- Data integrity issues
- Insufficient testing
- Incomplete or unclear data
Why?
- Incomplete CSV understanding
- Disparate Processes
- Regulatory recommendation
Avoid!
- Align all processes
- Implement proper Quality systems
- Upgrade Procedural controls
- Increased understanding, implementation, judicious use
Ensured;
- Data Integrity
- Trustworthy Computer systems
- Change control based changes
What you have?
- Validated computer systems
- Compliance
- Electronic records and signatures
- Audit trails
- Easy audit preparedness
It is not just sharpening these tools, but understanding the guideline with utmost common sense and applicability can…
Lead up to Controlled, Cost effective CSV…
