Identify the controlled version
Record the document identifier, revision and owner before exporting a review copy.
GxP · Life-sciences document exchange
GxP document exchange and quality review
When a quality document goes to an external reviewer, the returned comments must be traceable to the version issued. Choose a representative record and test how the review returns to your quality system.
Follow the external review
Name the reviewer and record what they are being asked to approve or comment on.
Reconcile the response
Match the returned comments to the issued revision before updating the authoritative record.
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Test one quality document handover
Use sample material to follow issue, external review and return. Ask quality assurance to assess the intended use and evidence at each step.
Quality documentation
A clear connection to the approved source.
Use a document identifier and revision to connect an exported review copy to the controlled record.
Review point: Which system holds the authoritative record, and how are superseded copies handled?
Laboratory collaboration
Preserve the information needed to interpret results.
Identify the metadata and supporting context the reviewer needs to understand the result.
Review point: What must accompany the result for another team to understand and verify it?
External review
Define the return journey.
Assign someone to reconcile returned comments and preserve the review decision in the quality system.
Review point: How does the reviewed copy reconnect with your quality system?
Data integrity
travels with
the record.
MHRA guidance describes data integrity across the lifecycle using ALCOA: attributable, legible, contemporaneous, original and accurate. Completeness, consistency, endurance and availability also matter.
Identity + contextCan a reviewer establish who created the information and what it represents?
Content + historyDoes the handover preserve the material needed to interpret the record?
Access + retrievalCan authorised teams retrieve the right information when required?
For UK GLP, consult the OECD data-integrity guidance identified by MHRA as taking precedence. Use the framework appropriate to your activity.
Validate the use.
Document the boundaries.
Define what the exchange service is intended to do within your quality process. Identify the interfaces, responsibilities and evidence needed before approval.
Bring one document
through the process.
Use sample information to walk through preparation, exchange and reconciliation with MX. Your quality team can then assess the proposed service against its intended use.
Explore a controlled handoverQuestions for
your review.
Is GxP a single product certification?
No. GxP describes several good-practice disciplines. Applicable requirements depend on the activity, record and jurisdiction. This page does not assert that MX has a universal GxP certification.
Can file transfer replace a validated quality system?
It should not be assumed to do so. Define the role of each system, the authoritative record and the validation work needed for the end-to-end process.
Does a PDF always preserve the original record?
No. A static export may omit metadata or dynamic functionality needed to understand the source. Determine what constitutes a complete record for the specific process.
Is the guidance identical in the UK and US?
No. Local regulatory expectations and the applicable good-practice discipline differ. UK teams should consult relevant MHRA guidance; US teams should consider applicable FDA requirements.