Data Archival for Regulated Labs

Name: Data Archival for Regulated Labs
Brand: Splashlake

Why is Data Archival Important for Regulated Labs?

GLP, GCP, GMP and ISO/IEC 17025 compliant labs must adhere to the archival requirements outlined by regulatory agencies such as the FDA and EMA, and other regulatory bodies. Data archival focuses on maintaining data integrity, availability and continuous accessibility over a specified retention period. All data must be made available for audit or inspection purposes to demonstrate treatment safety and efficacy, and to support new products advancing to clinical trials, manufacturing and distribution. Secure and reliable archival is also crucial for organizations to protect their valuable Intellectual Property (IP), to ensure it is safely stored but also easily retrievable. Archived study data may also be required to support product claims or patents.

Organizations require long-term, immutable storage of data, enabling access to approved individuals and auditors or inspectors as required.

How Does Splashlake Handle Long-Term Data Archival?

Splashlake uses two key roles to manage archival:

The Digital Archivist moves data into the archive and manages access. Data access is limited to the Digital Archivist, who can place data into a “Digital Reading Room” for authorized personnel upon request.
In GLP, only Archive Submitters can request the transfer of documents to the archive.

Key Elements of Splashlake Data Archival

Splashlake supports the archival of various content types, ensuring that both raw and processed data is archived in a human-readable, vendor-neutral format, along with any related documents.
Metadata remains visible to enable navigation and search within the archive.
Audit trails record who creates the archive, who has access to and views the data, and when.
In GMP, data are automatically archived when saved, or following a predefined period after the data set is saved.
Tamper-proof Write Once, Read Many (WORM) storage prevents modifications.
“War Room” features facilitate internal data review ahead of an external audit, so only required data is provided to inspectors via an “Inspection Room”.