Skip links

Data integrity : Practical and risk based approach

As Data Vulnerability is frequently detected during the audits, GMP auditors around the world are now placing importance on Data Integrity to prevent this problem affecting patient health because of poor or unreliable product quality.

To comply with Data Integrity regulations requires not only cooperation from both operators and supervisors. The company must be capable of managing data lifecycle for both paper record and electronic data.

There are several ways to manage your data according to Data Integrity regulations.
Feel free to take a visit at our booth to figure out which one suits you the most.

With over 10 years of experience and more than 100 customers, we assure you that our team is more than capable of being a consultant in GMP compliance and Data Integrity for your business.

BatchLine – electronic Batch Record (EBR) that is developed based on GMP and Data Integrity ideology. All batch records have audit trails for tracking and inspection purpose.

Master Control – an eQMS that manages document lifecycle. The software is 100% comply with PIC/s GMP, 21 CFR Part 11 and Data Integrity.

Leave a comment