Drug development is a process that’s expectedly guided by a lot of regulations in relation to all its aspects, including data. Making sure that your data activities remain compliant with all these regulations can be a consuming act while also monitoring the drug manufacturing itself.
You have to make sure that systems in your Good Practice (GxP) areas stay validated. Implement in your quality management systems all data integrity (DI) and compliance aspects. Additionally, you need to ensure that all your staff are trained to meet all the industry-given prerequisites.
In other words, you need to stay ready for data integrity inspections at all times. But this is easier said than done. Navigate here for a tool that can help streamline your data integrity processes.
However, to get the most out of any tool, you need to embed data integrity at the core of your drug development structures and company in general. There are a lot of moving parts, and it’s easy to lose control of the wheel. You’ll need to monitor and, most of all, establish your company’s data integrity culture such that you won’t have to prepare for inspections because you’ll already be prepared.
The ALCOA+ Principle
One of the best ways to prepare for an audit is to conduct an internal audit to test and ensure your systems are compliant with regulations.
What’s the guideline you could use in these internal audits? A good standard is to use the ALCOA principle. It’s an acronym for:
- Attributable. Can you trace who performed any given action or who acquired your data?
- Legible. Is your data written in a clear, easy-to-read, and understandable way?
- Contemporaneous. Are you recording your data in real-time?
- Original. Are you using a true copy or, most preferably, a first record copy?
- Accurate. Are the results recorded in your system error-free and scientifically valid?
The plus in ALCOA+ emphasizes whether you’ve conducted your day audit thoroughly, and the criteria being:
- Complete. This means you must apply the ALCOA principle on all your data, including in any reanalysis.
- Consistent. You’ve applied all elements of ALCOA have been done in sequence and been dated and time-stamped.
- Enduring. You’ve recorded it in a format that you can easily maintain and is permanent throughout the data’s lifecycle.
- Available. Your data should be easily accessible and handy for audit, review, or inspection over its lifecycle.
You can only meet DI expectations if you’ve sufficiently addressed all elements of the ALCOA+ principles that have been applied to all aspects of your data.
Tips For Data Integrity Compliance During Development
With an understanding of data integrity and the aspects that it looks at, here are some tips on how you can achieve data compliance throughout your drug development process:
- Create Awareness
You should embed in your company culture the primacy of data integrity. A good way to do that is to make sure all your team members are trained and have a thorough understanding of the ALCOA+ principles and anything else that might apply.
When a team or an individual is working on their assigned task, it’ll be easy for them to identify as correct potential data integrity issues before they ambush everyone during an audit.
When you conduct the training, make sure you document it well for easy access by the team for reference or to be presented to a regulator should there be a need.
- Classify Your Data
There are various criteria for day classification. You can class it according to value, criticality, and sensitivity in relation to your products as well as processes.
Classifying your data in this way will provide you with a baseline for security controls. Who has access to what level of data? Organizing sensitive or confidential data automatically excludes certain people in and outside of the team. Make these barricades as straightforward as possible to keep your data secure.
- Track Your Data Flows
When dealing with your data, there are certain aspects you need to cover constantly. You need to:
- Create or record all GxP information
- Collect, process, and transfer data
- Monitor reporting, data use, replications, and distribution
- Monitor data retention (archiving included), backup, obsoleting, restoration, and retirement
How your data will flow needs to be defined as early as possible in the assignment and constantly supported and verified throughout the project’s lifecycle. In the event that six data is needed, you should be able to reconstruct the roadmap to your drug’s development, including who contributed to what activity and when they do so.
- Implement Access Controls
Your staff has different responsibilities through the level of your drug development project. They also have different levels of training. Use these and other distinctions to help you create an access control system in your data systems. Only authorized team members will be able to access certain classes of data.
To better implement your policies around access control correctly, it’ll be a good idea to use software designed for this specific purpose. Software of this nature will at least help you establish and keep up-to-date track of your audit trail (a record of activities done within the system in the order in which they happened). You’ll know your software is sufficient for the job when you can reconstruct the sequence and detail around an activity that happened within your system.
As part of your internal inspection, extract samples of audit trails, metadata, raw data, and test them against the day integrity regulations. That way, you can troubleshoot problems internally and ensure you’re compliant at all times and all stages.
Data integrity is a hard thing to get a perfect score on. But with expert advice to help you ascertain the scope and depth of your problem, execute relevant gap assessments, and implement an action plan to correct problem areas, you can make significant strides.