Data integrity challenges faced by a number of pharma industries in developing and third world countries including India are mainly due to non-compliance of GxP (good variable factor practices) guidelines, thereby resulting in inaccuracy and inconsistency in data generated during GxP. In a bid to ensure US FDA data integrity compliance, industry best practices are to be followed, especially when dealing with electronic records, said Ram Yeleswarapu, president & CEO, TAKE Solutions.
GxP is a general term for good (anything) practice quality guidelines and regulations that are used in many fields including pharmaceutical industries.
Data integrity is essential to confirm that the products in question are high-quality and safe for human use. Indian-based pharmaceutical manufacturers are a leading source of API and generic drug products in the United States. Hence it is extremely important for US FDA to ensure that the drugs being exported meet US safety and efficacy standards.
The Agency expects that all data submitted to it be reliable and accurate and has stepped up efforts to ensure that drug manufacturers comply with all GMPs. Form 483s issued last year to Indian drug manufacturers had a high level of data integrity issues.
Taking serious note of data integrity challenges faced by pharma companies, Navitas, the pure-play Life Sciences brand of TAKE Solutions, has come up with all the software tools used in validated environments that are cGMP, 21 CFR Part 11 and Annex 11 compliant. TAKE's quality team is very proactive in conducting internal & external audits during the SDLC of the software tools and ensuring that they meet the industry best standards. This ensures that data inconsistency and inaccuracy are nipped in the bud, said Yeleswarapu.
The web-based pharmaREADY electronic document management and eSubmissions solution suite which meets regulatory requirements is fully 21 CFR Part 11 and cGMP compliant. pharmaREADY helps pharma companies to properly manage documents, their metadata and their workflows in a prescribed way. Audit logs and audit trails are captured at every step thus enabling auditors to reconstruct the course of events whenever required. Since these audit logs and trails are read only and cannot be modified or deleted, any discrepancy in data is easily revealed, he added.
The company also offers QMS implementation services to pharma companies to ensure compliance and data integrity. It also provides third party validation services which ensures that the software tools used by pharma companies are installed and validated and working as intended, thereby enforcing trained users to operate such systems without any scope for data inaccuracy or inconsistency, concluded TAKE president.