Over the past few years, Data integrity has become a serious issue and therefore is a core focus of many enterprises. The FDA published a Data Integrity Guidance Document outlining compliance that addresses the role of data integrity for the industry. The document is a result of the FDA increasingly observing violations involving data integrity during inspections. These violations have led to FDA warning letters, import alerts, and consent decrees. The guidance document answers integrity questions and strives to clarify what the FDA expects from businesses.
What is data integrity?
Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts.
Maintaining or keeping data consistent throughout its lifecycle is a matter of protecting it (security) so that it’s reliable. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.
And data that’s reliable is simply able to meet certain standards, with which compliance is necessary.
Data is expected to be:
- Attributable –Data ought to demonstrate who handled it, when it was operated and used, and what is it about.
- Legible – Data ought to be simple and plane, stored permanently and the source should be preserved.
- Contemporaneous –Data ought to be recorded as it was operated or used, and at the time it was executed.
- Original – Source information ought to be accessible and protected in its original form.
- Accurate – There should be no errors on the data, and it should comply with the set protocol.
How to minimize data integrity risks?
To accomplish this, there are effective strategies that companies may implement to manage their data integrity risks and ensure their data respects the ALCOA principle. By moving from a reactive to a proactive way of thinking, the following key requirements and controls may be put in place to ensure data integrity and minimize risk for your organization.
- Ensure all computer systems are 21 CFR Part 11 compliant it requires that electronic records are trustworthy, reliable, and equivalent to paper records. All computer systems that store data used to make quality decisions must be compliant, making it a perfect place to start with data integrity.
- Follow a software development lifecycle
An SDLC methodology to address pertinent lifecycle phases from software development, software testing, integration, and installation to ongoing system maintenance. All computer systems should be appropriately developed, tested, and assessed on a regular basis.
- Validate your computer systems
Software validation provides documented evidence to deliver assurance that a specific product meets its pre-determined specifications and quality attributes. it is key to work with vendors to ensure your system can be validated.
- Implement audit trails
A secure, computer-generated, audit trail records the identity, date, and time of data entries, changes, and deletions. Audit trails ensure the trustworthiness of the electronic record and assure records have not been modified or deleted.
- Implement error detection software
Automated inspection software can help verify important documents to ensure their accuracy. Manual proofreading or inspections are proven to be inefficient and often cannot assure that files are error-free.
- Secure your records with limited system access
All systems should have a two-way authentication login, and the access to be provided to only to those required individuals to guarantee data integrity.
- Maintain backup and recovery procedures
A backup and recovery strategy is in place in the event of data loss and application errors. This procedure ensures the data is achieved through media recovery and the restoration of both physical and logical data and protect the integrity of the database files.
- Protect the physical and logical security of systems
A mechanism is needed to protect the physical and logical security of your systems, change management, service management, and system continuity. This will assure continued support of the systems and development of the organization.
- Establish a vendor management qualification program
Evaluate all vendors supplying products are quality products that meet the required standard. A continuous appraisal should be there even after the initial evaluation.
- Training User and maintain training records
Users should be trained properly so that they have the right knowledge to perform their job competently. Documented training records provide this proof.
Data integrity success
If you are reading this, you are probably aware of how important it is to secure your data. Data integrity is a thought process and if implemented properly data infrastructure can be an asset for the organization.