Indian CRO - Issues, Challenges and Possible Solutions - Regaining and Retaining Integrity
Rajendra Prasad M,
Chief Executive Officer & Executive Director,
Jeevan Scientific Technology Limited
Data integrity in different pharmaceutical processes has become a major issue in pharma industry. In recent times, the regulatory health authorities have identified many of the Indian pharmaceutical organizations and CROs have had problems with the data integrity practices at their respective facilities.
Data integrity is maintaining and assuring the accuracy and consistency of data over its entire life-cycle. It also ensures that products meet pre-established specifications. Data integrity problem related to all GxP environments includes but not limited to development, validation, stability, manufacturing, packaging, quality control, quality assurance, clinical research and finally inspectional activities. Some of the macro root causes for data integrity are financial motivation, business pressure, organizational culture and working environment.
To retain data integrity and regaining the level of confidence from the agencies, organizations must enforce the best practices by developing corporate ethics program, giving the necessary resources to staff and zero tolerance for intentional falsification of records. Overall, internal/external audit programs with legal and technical experts are important investments to conserve the data integrity.
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