Why Data Integrity Matters In Your Analytical Instruments

Data integrity is defined as the extent to which all data, whether electronic or paper-based, is complete, consistent, accurate, trustworthy and reliable throughout the data lifecycle – from creation through archival stages and its eventual destruction. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, accurate, enduring, complete and consistent (ALCOA+)

Regulatory agencies, as well as the life sciences industry, rely on this data to ensure subject and patient rights in addition to the safety, efficacy and scientific value of clinical studies Data integrity is paramount to ensuring the validity of the data and its analyses. Advanced Instruments osmometers help allow customers to meet the strict data integrity requirements of 21 CFR part 11 and EU Annex 11.

For researchers (CDER), one of FDA’s biggest concerns is integrity of electronic data. Three of ten recent audits revealed data of highly questionable reliability that are currently under review at CDER. Additionally, the number of FDA warning letters pertaining to data integrity has grown exponentially, as FDA puts more focus on data integrity during inspections.

US and EU regulatory authorities have defined the criteria for ensuring trustworthy and reliable electronic records in computerized systems via a process known as compliance with data integrity. Regulations and standards such as 21 CFR Part 11, EudraLex Vol 4. Annex 11, GMP, and ISO 17025 establish controls for the use of electronic data systems, with the goal of reducing errors, simplifying processes and reinforcing compliance.

In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the pharmaceutical and biotechnology industries, this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as compliance with data integrity. The highest risks, when not working in a compliant manner, lie in import bans, product recalls, or even the closing of production plants. The FDA defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records in Title 21 of the Code of Federal Regulations (21 CFR) Part 11.

By becoming compliant with FDA 21 CFR Part 11 compliant, organizations benefit from:

• Reduced costs by removing manual and paper processes while improving workflow processes
• Reduced costs of managing and documenting their entire record lifecycle, from routing and approval workflow, version control, and comparison to audit trails and reports
• Improved traceability—e-records are simpler for gathering, filtering, and presenting information for internal use or FDA audits
• Stronger controls over users’ ability to design, amend, and approve forms
• Better management of global data, including product data, symbols, graphics, and languages
• Compliance with data integrity requirements