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Manufacturers in regulated life sciences businesses depend on data integrity to check their products’ quality, safety, and effectiveness before releasing them to the market. Consequently, regulatory authorities have high expectations for data quality and integrity.
Companies that don’t follow the regulatory standards and compliance could get fined, jailed, or have their products taken away.
To comply, businesses must make significant changes to their current data practices and systems. This will need initiatives across the whole business and cooperation across different departments.
Keeping your business’s infrastructure in good shape requires that you find and fix common data integrity issues. Review these methods for ensuring data integrity.
At its most fundamental, data integrity is the dependability and reliability of data throughout its existence. This involves creating or acquiring, transferring, storing, backing up, and archiving or destroying. Data integrity ensures the data is not corrupted or compromised by human error or malicious activity.
It is the status of data (valid or invalid) and the process of validating it through error and anomaly detection. This is crucial because inaccurate data’s ripple effect can impact so many of the world’s functions. For example, in business, leisure, health, science, education, and governance.
ALCOA is a framework regulated businesses use to ensure data integrity. This is essential to Good Documentation Practice (GDP).
ALCOA refers to paper or electronic data and is characterized as Attributable, Legible, Contemporaneous, Original, and Accurate by US FDA regulations. You should implement these simple concepts in your data life cycle, GDP, and data integrity initiatives.
It is impossible to overstate the significance of data integrity. Any company unable to assure data integrity won’t know if its critical services are being done correctly, affecting its future.
Beyond the immediate losses are the broader issues of public confidence and brand credibility.
Organizations ensuring data integrity face several issues, including:
A transfer error occurs when you cannot transfer data between databases. Without controls in place, this will decrease the integrity of the data. For example:
These transfer errors happen when parts of data in a relational database are in the destination table but not the source table.
Human error is a significant threat to the integrity of data in companies. This usually happens when users enter:
This is why it’s imperative not to make mistakes with information protection procedures.
Another rather prevalent data integrity issue is noncompliance with regulations. Failure to comply with regulations such as GDPR may lead to delayed product launches and severe penalties.
A siloed environment can pose a risk to your data integrity and compliance. It may cause unreliable data that can potentially decrease efficiency and productivity.
The possibility of receiving an FDA (the United States Food and Drug Administration) warning letter is one of the most severe obstacles faced by firms operating in the biologics industry. An, FDA warning letter is a formal notification of one or more serious violations.
The FDA defines a warning letter as:
“A letter notifying a regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and other federal statutes.”
If your company receives such a notice of noncompliance from the FDA, you should immediately contact an experienced FDA defense attorney. Not responding or responding incorrectly could result in formal civil and criminal investigations against your company.
You can avoid common data integrity problems by using the methods below to protect data integrity:
An audit trail records every data transaction: who, what, when, where, and why. Often referred to as the 5 W’s. It lets you reconstruct any data-related event.
The audit trail ensures data integrity in highly regulated industries, such as life science
Application security aims to defend data and software application code from online dangers. Application security must be in place throughout the entire development process. This includes design, development, and deployment processes.
Applications that require mission-critical access or contain sensitive data should use strong authentication.
Configuring data encryption and integrity is dangerous using the default parameter settings. Understanding the defaults and changing them as needed requires some time.
Compliance Management System (CMS) procedures have historically been carried out in a “check the box” manner. This has resulted in “after the fact” or reactive discovery and analysis to find compliance issues and control breakdowns.
It is, therefore, obvious that a more real-time approach to compliance is required.
The initial five guiding principles of data integrity are abbreviated as ALCOA. These guidelines are:
ALCOA+ has been upgraded to reflect these initial ALCOA concepts. With four additions, the initial ideas are still valid:
Your company’s data, whether written or electronic, must be kept meeting regulatory obligations.
Life science organizations trying to implement good data practices face various difficulties. These consist of:
Workers frequently attend many training sessions in a short amount of time. As a result, your staff might not be able to comprehend all the standards and requirements regarding data integrity fully.
Sometimes, employees miss training sessions because they are too busy, or the materials aren’t perfect.
Life science companies must incorporate business and IT safeguards and controls. In addition, process or system validation ensures timely, accurate data.
Data integrity may be compromised if proper precautions are not applied throughout the data life cycle. A real-time compliance monitoring software can ensure data integrity within your operations and workflows. It monitors risks and nonconformances to mitigate issues and compliance risks that may affect your company’s reputation.
Businesses that contract out their work are accountable for the accuracy of all the data involved. This includes any that are kept up to date by any subcontracting organization or service provider.
Companies that outsource should guarantee their subcontractors and suppliers have relevant computing services. These should include:
Maintaining data integrity throughout a company’s extended enterprise can be difficult.
Your organization has the potential to violate common data integrity issues and rules if your data is deleted, damaged, or breached. Data in the pharmaceutical and medical manufacturing sectors. ALCOA principles will assist you in ensuring data integrity, particularly when choosing data solutions and establishing data recording and documenting standards.
Creating and following a well-structured, recorded data management plan can help preserve data integrity.
Automating data collection, storage, and analysis prevents common data integrity issues. Book a demo with our Compliance Builder and discover the unique benefits of real-time regulatory compliance throughout your organization. It ensures data integrity and mitigates compliance risks for your spreadsheets, instruments, equipment, and digital processes.
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540