AVOID DIFFICULT INSPECTION FINDINGS
Regulatory Data Integrity findings are on the rise due to the exploding increase of data from electronic and manual data collection systems. A sample analysis of Data Integrity warning letters reveals that the majority of findings result from incomplete/false data followed by Data Security Controls and Audit Trail deficiencies. Let us help you ensure your data is complete, accurate, and you have the right Data Integrity policies, procedures and governance in place.
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Data Integrity And Paperless Validation In Life Sciences
Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. across many documents can be challenging.
CG MINIMIZES
DATA INTEGRITY FRICTIONS
We help our clients answer these common questions:
When does data get created?
How do we define and identify data life-cycle controls?
Who owns the data and when?
What to review in an Audit Trail to demonstrate DI compliance?
How to document routine Audit Trail reviews?
What’s the best approach to verify Backups under DI?
Given my current and future state, what kind of governance is best for my organization?
CG’s support in aligning our systems with industry regulations has transformed our compliance practices. Thanks to their guidance, we are confidently embracing compliance challenges with necessary skillsets for ensuring success.
– Chief Information Officer, Pharmaceutical Company
CG’s Proven Approach to Improving Data Integrity
Data Integrity Assessments
Our experts conduct Gap Assessments in identified process areas such as QMS SOPs, Digital Systems, Lab Equipment, Lab SOPs, Batch Record and Manufacturing Processes, Design Control, and Clinical. Our assessments contain associated risk ratings and remediation priority ratings.
Data Integrity Assessment Results & Remediation
Our experts review Data Integrity Assessment results with the client and propose pragmatic, “right-sized” remediation efforts for updating SOPs/execution practices. These remediation activities are identified “contextually” with Return on Investment in mind.
Fast track Data Integrity using CSA
We fast-track Data Integrity compliance using Computer Software Assurance (CSA) principles. We co-authored the “CSA Appendix” in ISPE GAMP Data Integrity by Design Good Practice Guide.