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Laboratory Asset Relocation for Pharmaceutical & GMP Facilities

Femto Scientific relocates cGMP laboratory and manufacturing equipment as a controlled change event — GxP-compliant decommissioning, documented chain of custody, validated transport, and full IQ/OQ/PQ recommissioning with NIST-traceable recalibration at the new site, so your balances, HPLC systems, incubators, and analyzers return to service with an unbroken record that holds up under an FDA 21 CFR Part 211 inspection.

  • GxP-compliant decommissioning with as-found status
  • Full IQ/OQ/PQ re-qualification at the new site
  • NIST-traceable recalibration after the move
  • Change-control-ready documentation package
  • FDA 21 CFR Part 211 & Part 11 aligned records
  • Documented chain of custody end-to-end
  • Validated transport & condition monitoring
  • Single accredited vendor, single audit trail

Move your GMP instruments without opening a gap in your compliance record.

Why a Lab Move Is a Regulated Change Event in a cGMP Facility

In a cGMP environment, every calibrated instrument feeds data into batch records, stability studies, and release decisions. Relocating that instrument is a change that must be assessed, documented, and re-qualified — not simply unplugged and moved. FDA 21 CFR Part 211 sets the calibration and equipment expectations; a documented decommissioning-to-recommissioning workflow with IQ/OQ/PQ and NIST-traceable recalibration is what demonstrates the move preserved the instrument’s validated state.

FDA 21 CFR Part 211 & Change Control

Equipment used in drug manufacturing and testing must be calibrated and qualified on a written program, and a relocation is a change requiring impact assessment and deviation handling if an instrument is found out of specification. Our relocation package produces the decommissioning records, IQ/OQ/PQ protocols, and calibration certificates your quality unit needs to close the change control.

IQ/OQ/PQ Re-Qualification

A moved instrument is not a qualified instrument until it has been re-qualified in its new location. We perform Installation Qualification, Operational Qualification, and Performance Qualification against written acceptance criteria under the new site conditions, then issue a NIST-traceable calibration certificate reflecting the new address.

Chain of Custody & Data Integrity

21 CFR Part 11 and ALCOA+ expect an attributable, contemporaneous record. Our documented chain of custody — from as-found decommissioning through delivery verification — proves no undocumented handling could have affected the instrument, so any out-of-tolerance finding at the new site can be scoped and impact-assessed with confidence.

Analytical balance and cGMP laboratory instruments decommissioned and crated for a validated relocation

A Decommissioning-to-Recommissioning Workflow Built for GxP

Every regulated instrument is decommissioned with its as-found calibration status captured, crated to instrument-specific specifications, transported under documented custody, and recommissioned with a full qualification sequence — a single package that integrates directly into your change management system.

  • As-found calibration status & GxP shutdown
  • Crating specs & validated transport conditions
  • Documented chain of custody
  • IQ/OQ/PQ qualification at the new site
  • NIST-traceable recalibration & updated certificates
  • Change control documentation package

Review the full scope and service tiers on the laboratory asset relocation service page, or see our temperature & humidity mapping for the qualification studies your relocated storage and stability equipment will need.

Pharmaceutical & GMP Laboratory Relocation FAQs

Put Your GMP Instrument Move on a Defensible Qualification Program

Tell us your instrument count, types, and destination — we’ll return a scope with decommissioning, validated transport requirements, and an IQ/OQ/PQ recommissioning plan that keeps your change control clean.

Request a GMP Relocation Quote +1-800-631-0263