In Pharmaceutical Industry, it’s extremely important to maintain data integrity, as it ensures the data is complete and secure, and has not been compromised on quality, impacting the lives of patients.
The Challenges
The pharmaceutical sector is well aware of the importance of data integrity compliance, as the consequences of a mistake may be quite severe and costly.
In 2019, FDA issued 19 warning letters out of 41 to Indian pharma companies owing to various deficiencies in adhering to Current Good Manufacturing Practices.
Most of the FDA warning letters are issued for failure in data integrity and Pharma companies are unable to meet the integrity of data primarily due to quality control. The most common issues found are failure to adequately document deviations and CAPAs, ensure computer system log-ins are secure and never shared, restrict system administration rights, conducting data audits in a timely manner, Inadequate data backup schedules, Issues with signatures etc.
The Way Forward
Let’s be honest, getting data integrity right is not easy, as it requires a continuous, concentrated effort to develop and maintain the policies, culture, and discipline required to avoid regulatory issues. However, it is a far, far greater pain to NOT do it right.
The benefits of automation and digital transformation extend beyond reducing labour costs, as it also results in more efficient manufacturing processes, better compliance checks, improved product quality, real-time monitoring, and faster time to market. Furthermore, it helps strengthen the data integrity of drugs throughout its life cycle.
AmpleLogic’s 18+ pharma focussed enterprise digital solutions, are supporting lifesciences industry globally for over a decade, whether it comes to maintain quality, learning, document management, stability management, calibration management, environment monitoring, APQR etc. to quote a few examples below:
- In manual document preparation, it is difficult to retrieve, trace, reconcile data and maintain version control. AmpleLogic’s Electronic Document Management Software with dynamic and advanced search functions built into the system, allows users to maintain data electronically and access anytime, anywhere on any device and reduced manual errors leading to address data integrity issues.
- Integrated Electronic Quality Management, learning management and Document management: Traceability of Change Request in EQMS, Procedural update in DMS and Training completion in LMS before publishing the Procedure in DMS and closing the Change Control in QMS.
- Electronic Logbook: Manual errors of Equipment Start and Stop in Equipment Sequential Logs will be eliminated with proper validations during data entry, Document Management Software, Calibration Management, Stability Management.
- APQR: Any time CP, CPK and CPV will help the Pharma companies in continuous Process verification leading to minimizing the OOS and OOT, allows to minimize the cost of Compliance.
- Environment monitoring Software for microbiology Environments: Complete record of atypical and fungal colonies observations, left and right finger dabs, aseptic activity, and acceptable limits helps in Preventive measures in order to maintain full compliance.
- Alarm Management Software, developed on new age Low Code Platform, can easily monitor multiple alarms and give auto alerts in case of equipment failure or a procedural error. It helps organizations in reducing process inconsistencies or problems that may need rework or even result in product loss.
The time, and cost of fixing Data Integrity regulatory deficiency significantly outweigh the investment of time and energy to create appropriate Data Integrity systems and controls.
The Conclusion
In a regulatory compliant Industry, Digitization shall increase production efficiency by automating workflow processes that were previously performed manually and shall support meeting data integrity requirements by eliminating errors. At the same time, digitization can have a positive effect on the job satisfaction of the lab staff by relieving them of cumbersome tasks.
It is my opinion, that appropriate investment in the right technologies to manage Data Integrity, affords a company a sustainable strategic advantage.
