01
Architecture & system selection
Roles and boundaries of LIMS, ELN, CDS and SDMS; platform requirements and selection. Define responsibilities and workflows before adding another system.
PHARMA LAB · PL-06
Digital Lab & Data Integrity
From the instrument to the data, without losing context.
Define how instruments, systems and people manage laboratory work. Explore LIMS, CDS, ELN and SDMS, integration, review, access and data retention throughout the sample lifecycle.
Explore the digital laboratory workflow.
Start with architecture, chromatographic data or a stage in the record lifecycle.
02
Chromatographic data
Peak integration, reprocessing, audit trail review and control of sequences, injections and reinjections. Reconstruct the data without confusing processing with physical instrument performance.
03
Integration & sample workflow
Instrument-to-LIMS interfaces, data mapping, errors and reconciliation. Follow sample identification, chain of custody, master data and result review.
04
Software assurance, access & compliance
Spreadsheets, LIMS/CDS validation, Annex 11 and Part 11 applicability, user roles, electronic signatures and time synchronisation. Relate controls to actual laboratory use.
05
Retention, migration & support
Backup and restoration, archiving, migration, remote support, updates and hybrid records. Distinguish long-term retention, operational availability and reconstruction of activities.
06
Suppliers & digitalisation roadmap
Software and cloud supplier qualification, responsibilities, integration and project priorities. Build the digital pathway around identifiable problems and dependencies.
Laboratory workflows, not a duplicate generic CSV guide.
Compliance is addressed through concrete laboratory activities. Instrument analytical performance remains in PL-01; existing general CSV and Data Integrity resources should be coordinated, not rewritten under a new title.
EXPERT SUPPORT
Working on a laboratory project?
Describe the instrument, intended use and support you need. GuideGxP will review the request and, where appropriate, may connect you with a suitable specialist.
