We all depend on accurate data, both on and off the job. Is your checking account balance accurate? Was the Tax reported on your W-2 correct? Did your last prescription have the correct dosage listed on it? In the Pharmaceutical and Medical Device Industries, the need for data integrity is essential and critical since it is directly tied to the safety, efficacy and quality of medical devices and medicines. Over the last two years, regulatory bodies including the FDA, MHRA, and WHO have issued guidance documents to assist manufacturers in addressing this Hot Topic.
Data integrity requires data to be Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). Being in a regulated industry, you know data integrity has always been important and you’ve undoubtedly been wrestling with the best way to ensure that integrity. How much and to what extent can data integrity be assured through laboratory software systems (i.e. LIMS and ELN)? What aspects need to be addressed through processes and procedures? How do you ensure that your laboratory systems and staff comply with the recent Data Integrity Regulatory Guidance from the FDA?
In this one hour webinar, a CSols’ Informatics Consultant, with real world experience, will explore how to develop an effective strategy and implement a plan to successfully ensure the quality and integrity of your data.
- The current regulatory landscapre and expectations for data integrity
- Proper assessment of data, systems and process to determine data integrity gaps
- How electronic laboratory systems can help you comply with data integrity regulatory requirements
- How to optimize systems you may already have, or what systems you may need, to help comply with data integrity regulatory expectations
- Use of efficient processes and how to increase compliance through Adoption