Authentic traceability
Chapter 4 of the 2023 Good Preparation Practices is clear: each batch must have a comprehensive dossier that allows for the reconstruction of all operations.
Contents required in the batch record for inspections:
Shelf Life
At least 1 year after the batch expiration date, or 10 years if the data is used for the traceability of the registry.
Balancing Demands and Practicality
On paper, the requirements are clear. In practice, however, they face several challenges:
Paradox
As traceability demands increase, the risk of documentation errors also rises—unless the system is automated.
Compliance as a byproduct, not a burden
QCRx® is not a compliance tool. It is an analytical control tool that, by design, automatically generates all the required documentation.
For each analysis, the system automatically logs:
BPP Requirement 2023
Dated and signed results
Physico-chemical assessments
Audit Findings
Operator Identification
Synopsis of irregularities
Long-term archiving
What QCRx® does
Automatic timestamping and operator identification
Spectroscopic analysis: molecule, concentration, solvent
Automated Verdict: Compliant / Non-compliant
User login is tracked with every action
Alert and Documentation of Non-Conformities
Stored and auditable data for review
The practical implications are as follows:
Zero re-entry
The results are directly integrated into the information system. No manual copying, no transcription errors.
No interpretation
The decision is automatic. No subjective judgment needs documentation.
Audit-ready
The inspector requires access to a batch record? A few clicks are all it takes to export the complete history.
Impact on Daily Practice
Without automated oversight
Manual completion of batch record
Manual re-entry of control outcomes
Pharmacist's written signature
Manual search for audits
Potential transcription error
Using QCRx®
Automated record generation
Direct injection into the prescribing software
Auditable electronic validation
Immediate export of the history
Raw, immutable data
QCRx® assists you in meeting the requirements of:
Observations
QCRx® is an analytical control tool, not a document management software. It generates control data compliant with the requirements: integrating these into your overall quality system remains your responsibility.
Streamline your compliance
Quality documentation should not be an end in itself. It serves as evidence that the work has been correctly performed. QCRx® automatically generates this proof with each inspection.
In a 30-minute demonstration, we will reveal:
How control data is generated and archived
How to generate a record for audit purposes
How does the system integrate with your existing information system?
