Benefits of a Data Archival Strategy for Life Sciences Companies

Organizations operating in the life sciences sector cannot get by without a robust data archival strategy within your Quality Management System (QMS). No longer considered just a best practice, this strategy ensures that all vital records, from research and development to production and quality control, are securely stored and easily retrievable. This approach safeguards compliance, facilitates audits and supports ongoing quality improvements.

Data archival is also the backbone of traceability and accountability in life sciences. It provides a reliable repository for historical data, ensuring that information can be accessed long after it was generated. This capability is essential, as meeting stringent regulatory requirements set forth by bodies, such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), mandate that records are preserved for specific periods. But possibly even more important, an effective archival strategy helps organizations mitigate risks associated with data loss, corruption or unauthorized access, all of which can have severe legal and financial repercussions.

A well-structured approach supports regulatory compliance, enhances operational efficiency and fosters a culture of continuous improvement. Below are some keys to unlocking the full potential of your QMS through effective data management and archival practices.

Reasons to Solidify Your Data Archival Strategy

Changes to Organizational Structure: When mergers, acquisitions and spin-offs take effect, companies must be able to quickly access aging data held in legacy applications and find ways to optimize current application support infrastructure.

Legal Implications: Regulated industry organizations can face legal disputes or litigation if you’re unable to produce proper information. Archiving relevant documents, including complaint data, product liability, data privacy and security, and other business processes provides valuable evidence during legal proceedings.

Authority Audit Preparedness: Documentation that reinforces the development of drugs and medical devices by a life sciences organization must be retained for inspection. For this reason, the security of these records remains a priority for life sciences companies.

Avoid Storage of Excess Data with Limited Value: Most stored quality data has little to no value, especially if being managed at scale. This only creates inefficiencies and disorganization, especially when operating under unstructured data.

Benefits of an Effective Data Archival Strategy

There are other advantages of an effective data archival strategy beyond maintaining compliance and meeting accessibility and security requirements. Production systems under this approach require fewer resources and run more efficiently. It enhances productivity and frees up teams to focus on more critical tasks. A proper data archival process also stabilizes reliable retention and organization of your historical data.

Solutions to Consider

Sikich Innovation LABS has developed an end-to-end data archive software solution for QMS: archiveIQ is a CFR 21 Part 11 compliant automated data archival utility, designed with a feature-rich user interface that allows for viewing, querying, and reporting on archived data. archiveIQ helps organizations streamline and safeguard permissions when multiple users have access to the software. Its flexible cost structure is based on the source system, not by user license.

Maintaining a data archival strategy within your QMS can help your life sciences organization with compliance, quality improvements, traceability and more. Please reach out to our solution consultants to learn more.