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Serialization and Data Integrity in the Life Sciences Industry

Data integrity is a global requirement for regulated medical industries. The integrity of data is extremely important to guarantee the quality of life science studies and products — and to ultimately ensure the safety of patients.

With the US, European, and Russian pharmaceutical serialization deadlines looming, the industry is busy implementing these new technologies to their production lines

Serialization, in effect, expands the digital dimension to production data. Instead of just master and batch data, there will be individual package-related data in cloud and ERP systems. Even the small-scale production sites that have been able to rely on paper-based reporting have to adopt digital reporting.

Of obvious importance is the need to reconcile data, not just materials, after the production run before the batch is released. The approved batch should not have serial numbers hanging loose, nor packages without serial numbers, nor serialized packages not accounted for. All the rejected packages with serial numbers must be accounted for.

Digital accounting makes the control of data integrity both easier and harder. On the other hand, the data systems can be made to provide an audit trail for every data read, write, and change, require digital identification of persons responsible and provide backups. On the other hand, people are prone to looking for shortcuts, especially during incidents. For example, if the person having the access rights to production line stop mitigation is not always close, the personnel may find a shortcut, e.g., having access keys are available at the production line to make quick changes and repairs. This results in obvious data integrity risks.

Data integrity might look like a simple issue with a modern computerized production control systems, but it is hardly so. There are interfaces between the systems: within the organization, between trading parties such as API manufacturers or CMOs and MAHs, and between the MAHs and cloud systems or government repositories, such as the European Hub in the EMVS, and MDLP in Russia.

Each data transfer contains the possibility of unintentional data changes. Guaranteeing the data integrity between ISA levels 2 (production line) and 3 (site/factory level) may well be troublesome if the software solutions on these levels are from different vendors. An example of an unintentional change of data was with HIV testing at a blood service years ago, where the transferred testing data was truncated and critical information lost — leading to people getting contaminated blood.

Compromising data integrity compromises also patient safety.

To meet regulatory expectations, data must be attributable, legible, contemporaneous, original, and accurate: “ALCOA,” a term already familiar to those involved with clinical trials (as well as those in the aluminum industry). Furthermore, data must meet the applicable requirements of GMP, GLP, GCP, QSRs, and ERES regulation such as 21 CFR Part 11.

Regulatory agencies have increased industry oversight regarding data integrity. The FDA, noting many Warning Letter and 483 observations, produced a draft guidance on the subject in 2016. FDA published the finalized guidance in December 2018. EMAWHO, and PIC/S have also published recent guidances on data integrity.

Automated Systems, Inc. can provide your firm with experienced resources to help you learn your level of compliance with current regulations, and determine appropriate and efficient courses of action. We can provide you with:

A gap analysis, which identifies:

The regulations, guidance, and industry standards that apply to your products

Your present level of compliance

A prioritized, risk-based course of action for remediation and improvement

Training on data integrity topics

Policy and SOP development

System configuration advice

Computer System Validation


Responses to regulatory agency observations

For 30 years, Automated Systems, Inc. has provided our life science community with solutions to data integrity problems. Please contact us to learn more about how we can customize our services and expertise to assist you.


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