STREAM at a Glance
In a few minutes the teaser shows the course of a data migration with STREAM: analysis of the source system, SHA-256-secured transfer, audit-ready migration report.
Data Migration in a GxP Environment: The Regulatory Requirement
In a regulated environment a system migration is not purely an IT project. EU GMP Annex 11 requires evidence that the value and meaning of the data were not altered during migration. That applies to measured values as much as to metadata, release records and audit trail entries.
The evidence decides, not the impression. Comparing file counts proves nothing about integrity, because a corrupted file counts the same as an intact one. STREAM therefore relies on a cryptographic comparison per file.
STREAM calculates a SHA-256 hash value before the transfer and again afterwards. If a value differs, the process stops with an error and the record stays on the deviation list. Data integrity under ALCOA+ is therefore evidenced, not asserted.
STREAM: Key Features
Use Cases for STREAM
System Replacement and System Migration
When a LIMS, ERP or DMS is retired, its historical data remains subject to retention, often for more than ten years. STREAM transfers it with a checksum and produces the evidence that the retirement documentation of the legacy system requires.
Data Centralisation
Consolidating stores from several source systems creates field conflicts and duplicate records. STREAM logs, per record, which source it came from and how it was mapped.
Cloud Migration in a GxP Environment
Moving to the cloud adds questions of storage location, responsibility and access. STREAM supplies the technical integrity evidence for the transfer; the contractual side is covered by supplier qualification.
Scope of Delivery and Operation
STREAM comes as a supported migration package. You receive:
- Analysis of source and target system with data model and field mapping
- Migration plan with scope, sequence, rollback and release criteria
- Test migration on a representative subset of the data
- Production migration with a hash comparison per file and a deviation list
- Migration report as an annex to your validation documentation
- Validation documentation for STREAM itself, including IQ and OQ
The accompanying test strategy follows the same approach as in computerised system validation.
Regulatory Framework
Data migration is governed by the requirements for computerised systems and for data integrity at the same time.
- EU GMP Annex 11: requires evidence that migration did not alter the value or meaning of the data.
- 21 CFR Part 11: requires accurate and complete copies of electronic records and their readability throughout the retention period.
- PIC/S PI 041 and the ALCOA+ principles: provide the criteria by which inspectors assess the completeness and attributability of migrated data.
We describe the underlying subject matter under Data Integrity and Computer System Validation (CSV).