The US Food and Drug Administration (FDA) published April 2016 the following draft of a new guideline for the requirements of data integrity:
Data integrity refers to the completeness, consistency and accuracy of data.
These type of data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
These requirements apply to data recorded in electronic and in paper format.
Integrity of data is a prerequisite for the regulated healthcare industry as decisions and assumptions on product quality and compliance meeting the applicable regulatory requirements are made based on specific product related data produced by a system.
Integrity and consistency of data are the foundation upon which decisions of product quality, safety and efficacy are made over the whole product life cycle and recently became a challenge for the industry.
Considering that raw data act as an evidence that drug products are safe, efficacious and manufactured using appropriate quality and regulatory standards required, violation of data integrity is considered to be a big deviation from legal practices by all leading regulatory Authorities.
In the recent year, FDA has increasingly observed violations involving data integrity and data validation issues during CGMP inspections and issued corresponding Warning Letters to these companies.
Please find an overview over recent Warning Letters:
FDA Warning Letters 2015
FDA Warning Letters 2016
FDA Warning Letters 2017
When using spreadsheets or programmable calculators for reduction of data generated by sample analysis or other relevant calculations, assurance is absolutely necessary that the results are valid. Individual spreadsheet functions can be considered as reliable if using a common application. Protection of spreadsheet parts is important to avoid unauthorized changes.
Validation with verification of the reliability of the spreadsheets by comparison with known results from known data is essential as well as corresponding original data or true copy archival.
Making data integrity and consistency a key element of your compliance strategy will give you a competitive advantage.
Using our data integrity procedures asserts you that your data records are reliable, accurate, complete, legible, attributable, intact and maintained within their original context, including their relationship to secondary data records.
With our experience as independent third party specialists and auditors in detecting data integrity problems we support you with:
- data integrity gap analysis
- data integrity remediation
- integration of data integrity procedures
- audits of you and your suppliers
- consistency checks raw data - database
- inspection preparation & support
- backup, restore & business continuity process
- chromatographic data archival solution
- computerized systems workflow validation
- complete qualification documentation
An issue we have seen coming up presently and gaining significant importance is the rise of whistle-blowers trying to distribute company internal data to different receivers mostly for personal profit reasons. Consistent data integrity procedures with appropriate data security implementation is essential to minimize this risk.
An fact often found is that companies have not implemented a suitable archiving solution.
Backup is not Archive and Archive is not Backup!
The 2 processes are needed and are complementary activities.
Archiving is long term storage of searchable electronic data as a original data or a true copy with all its attributes and raw data allowing quick search and access; it is not just a system status used for backup-restore.
Handling data integrity as a key element of your compliance strategy will give you a competitive advantage.