Title:Raw Data Management and Data Integrity in Pharmaceutical Product Development
Volume: 7
Issue: 3
Author(s): Jenish Parmar, Priti Mehta*, Rajvi Patel, Manan Shah and Charmy Kothari
Affiliation:
- Department of Pharmaceutical Analysis & Regulatory Affairs, Institute of Pharmacy, Nirma University, SG Highway, Ahmedabad-382481,India
Keywords:
Data, meta data, data integrity, audit trail, original records, electronic signature.
Abstract: In pharmaceuticals, raw data management is a tedious process that
comprises of obtaining the data, affirming the validity, and preserving the required
data to make certain of the quality, accuracy, and timeliness of the one
who is using the data. Raw data management makes processing, validation, and
other essential functions simpler and less time intensive. It provides actual information,
i.e., the information which has not undergone any processing either manually
or through an automated system. Raw data are managed by looking into integrity
issues, such as document falsification, failure to provide adequate controls,
and taking appropriate measures for its prevention. Also, access to the computer
system should be restricted to authorized personnel only. There should be
shared just-read client accounts that will stop the sharing of important data to personnel
other than the authorized one. Prevention and management include training,
good documentation practice, self-inspection, management strategy, and
global corrective and preventive actions. Also, a good moral practice should be
taught to the employees who are into documentation work.
