Life Sciences
Pharmaceutical, biotech, medical device, and CRO operations are inspected on documentation. Batch records, validation files, SOPs, and lab notebooks have to be controlled, attributable, and retrievable years later. DEX Imaging handles the print, scan, and records workflow behind that obligation, with secure-release printing and audit logging on every device.
The manufacturer lines DEX is certified on.
Life sciences is governed by GxP expectations and, for electronic records, by 21 CFR Part 11. The practical consequence is that a document's origin, version, and handling all have to be demonstrable, and an uncontrolled copy is a finding waiting to happen.
Quality, manufacturing, and regulatory affairs. SOPs, batch records, and validation documentation where an obsolete revision in circulation is a deviation. DEX supports controlled distribution and scan-to-archive so the current version is the one in use and the superseded one is retired.
QA and inspection readiness. Records that must be produced on demand and tied to who handled them. DEX supplies device-level audit logging and user authentication so print and scan activity on controlled documents is recorded rather than anonymous.
Equipment specified for controlled environments and cleanroom-adjacent space, with label and record output where the work happens rather than down the corridor.
MFPs, secure print, and document workflow for regulatory affairs, clinical operations, quality, and finance, under one fleet standard and one agreement.
Inspection Readiness
Inspection readiness is not a project you run before an audit. It is whether the record can be produced, and whether its handling can be explained, on the day someone asks. DEX configures scan-to-archive and retention workflow so controlled documents are searchable and their chain of handling is logged, and supplies certified data-destruction documentation when equipment leaves your facility. Validation and qualification requirements should be scoped with DEX against your own quality system.
Frequently asked
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