data integrity is crucial for any pharmaceutical company launching a product. Regulations dictate what must be done to ensure integrity, but achieving it is often complex. In the first part of our series, we look at some key challenges and how they can be overcome. In the second part, we will take a closer look at ALCOA+. ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) are principles used as guidelines to ensure accurate data integrity and correct documentation in the research, development and manufacture of Pharma and medical devices.
data integrity 101
ALCOA and ALCOA+ are terms used to manage data integrity and good documentation practices for the pharmaceutical and medtech industry. ALCOA, a term and framework originally introduced by the FDA, stands for:
Attributable: refers to the ability to trace data and actions back to people, systems or products.
Legible: means that data should be readable and clear, as long as it needs to be stored.
Contemporaneous: relates to events/data being recorded in real time.
Original: means storing the raw data in its true form, i.e. unchanged.
Accurate : means ensuring the correctness and truthfulness of the data and accurate recording of changes to it.
Young vs established organizations
Regardless of the size or maturity of your organization, you must follow the five ALCOA points if you want to meet the requirements and bring a product to market. For smaller, relatively young companies, it can be difficult to know where to start and how to ensure ALCOA. In such cases, a gap analysis is the best way to identify what is needed to meet the requirements. Based on this, an implementation plan can be developed. Large, well-established companies often have processes on Location for ALCOA. However, this does not mean that they do not face challenges; processes or not, new products or systems bring new data privacy challenges.
Common ALCOA data privacy challenges
Attributable (Traceable)
One of the key challenges in Attributable is not following official processes or not having the processes at Location to ensure data integrity. A classic example of this is the use, or rather abuse, of passwords. This can range from one user sharing their login details with another user to having a common login for all users. Processes must be in place at Location and staff must be trained to ensure that this does not happen. Furthermore, proper access control - i.e. ensuring that only the right people have access to the correct data - is not only a prerequisite for compliance, it is also an essential part of intellectual property protection.
Legible (Readable)
In today's digital world, readability is becoming less and less of an issue - unless you process a lot of your data. Readability usually involves handwritten notes that need to be transcribed and stored correctly. If you take notes as part of the development process, consider using a digital tablet or creating a daily procedure to transcribe them.
Readable means that your data should be readable over time, i.e. it is a necessity to have continuous backup of your data. For many products, so called COTS (Commercial Of The Shelf), this can sometimes be a problem. Quite often it turns out that they only support manual backup locally on a machine. In such cases, you should implement scripts to automate backup and then transfer the backups to a secure storage location at a predetermined frequency. Relying on users to back up data manually will backfire sooner or later; after all, we are only human.
Contemporary (Contemporary)
Surprisingly often it turns out that you can have problems with date and time formats in some COTS software. This is often configurable, but there are examples of these formats being different in different parts of the software. The same goes for handwritten notes that need to be signed and date stamped.
Original data
Production, testing and quality control generate large amounts of data. It needs to be stored securely in its true form in real time, even though it may change as you proceed with product development. A common challenge is to ensure that 'old data' is not replaced by changed data without traceability. This can be overcome by using a secure database to automatically store data at creation.
Accurate (Exakt)
To ensure accuracy, all data must be recorded as it changes during product development. Version control is necessary, as is data protection, to ensure that no unauthorized manipulation of data occurs. Effective document management is essential both to meet accuracy requirements and to streamline data integrity.
Overcoming the ALCOA challenges
If you are just starting with data integrity , we offer workshops and gap analyses to help you understand the ALCOA process and define a way forward to meet the requirements. For larger organizations, we can develop tailored solutions to meet the ALCOA challenges and ultimately help you get products to market faster.
Say hello to Anders Christensen
Anders Christensen has a PhD in analytical chemistry. As an expert consultant and Instructor at Plantvision, Anders supports pharmaceutical companies with validation and qualification of process equipment, computerized systems and laboratory instruments. Want to know more about ALCOA and what we can offer you and your company? Contact Anders.
Read the second part 2 " Meeting data integration challenges with ALCOA+ "
