Evidence that stands up to inspection

The MHRA’s “GXP” Data Integrity Guidance and Definitions (March 2018) sets out the Agency’s expectation that data used to make GxP decisions is complete, consistent and accurate throughout its lifecycle. For environmental monitoring that means readings must be captured contemporaneously, attributed to a source, protected from undetected change, and available for review. Eltek’s Darca Command records temperature and humidity continuously as time-stamped, tamper-evident data with a secure audit trail, giving quality teams the evidence data integrity expects. No monitoring product makes a facility compliant on its own; validation and process remain the organisation’s responsibility.

ALCOA+ is the shorthand for the principles of data integrity: attributable, legible, contemporaneous, original and accurate, extended by the “+” attributes complete, consistent, enduring and available. Continuous environmental monitoring supports each: readings are attributable to a source sensor and time, captured contemporaneously rather than transcribed, retained as the original record, accurate against UKAS-traceable calibration, and held complete and available for inspection. Eltek supplies the controls and the evidence; the validated, procedurally-controlled process around them remains yours.

An inspector typically wants to see that records are complete and contemporaneous, that the audit trail shows who changed what and when, that equipment is calibrated and that a temperature-mapping exercise was carried out before use. Continuous monitoring provides that evidence trail so records can be defended rather than reconstructed.

Alarm escalation warns staff while a unit is only beginning to drift, not after stock is lost. Catching a fridge, freezer or store early means fewer excursions become full deviations, which reduces investigations, wastage and the risk of an inspection finding.

GAMP 5, ISPE’s risk-based approach to compliant GxP computerised systems, classifies software by how much it is adapted to your use. Configured commercial software, adjusted to your alarm thresholds, users and reports without altering its code, is generally treated as Category 4, and is validated for the way your organisation configures and uses it. Monitoring software such as Darca Command typically sits here. Eltek supplies the calibration certificates, mapping reports and audit-trailed records that support your validation; qualifying the system in its intended use remains the organisation’s responsibility.

EU GMP Annex 11 (Computerised Systems), part of EudraLex Volume 4 and retained by the MHRA, sets out how computerised systems used in GMP environments should be controlled, covering risk management, validation, data and audit trails. On audit trails it states that “consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated ‘audit trail’).” Eltek’s Darca Command records continuous, time-stamped temperature and humidity data with a secure audit trail, giving quality teams the GMP-relevant history Annex 11 anticipates. Validation of the system in its intended use remains the organisation’s responsibility.

21 CFR Part 11 is a US FDA regulation. It is relevant to a UK organisation only where it has US market exposure, for example products destined for the US market or data supporting an FDA submission; for UK GMP the primary frameworks are EU GMP Annex 11 and the MHRA’s data-integrity guidance. Where Part 11 does apply, section 11.10(e) requires the “use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records,” and adds that “record changes shall not obscure previously recorded information.” Eltek’s Darca Command provides exactly this kind of audit trail. Configuration depends on system implementation and customer processes; Eltek supplies the evidence, the organisation owns validation.

No monitoring product makes a facility compliant on its own, and any supplier who claims otherwise should be treated with caution. Compliance depends on your validation, procedures and controls as well as the technology. What Eltek provides are the underlying controls regulators ask for: secure, computer-generated, time-stamped, tamper-evident records with full audit trails, role-based access and scheduled reporting, backed by UKAS-traceable calibration. Eltek supplies the evidence and controls that support your compliance; validation and process remain yours.

An excursion in a GDP-regulated area requires a documented response: record the breach — time, duration, temperature reached — identify the product held in the area during the event, investigate the root cause, assess whether the product has been affected, document the outcome of that assessment, and implement corrective action to prevent recurrence. Your monitoring system supplies the timestamped event record and the alarm log; the investigation, product assessment and corrective action are the organisation's responsibility. Your quality management system should define the escalation procedure, including when to inform the Responsible Person. EU GDP 2013/C 343/01 requires deviations from established procedures to be documented and investigated, with appropriate corrective and preventive actions applied in line with quality risk management principles.

The EU GDP guidelines, retained in UK law, require storage areas to be temperature-mapped before use, regardless of their size. What scales with the size and complexity of the space is the protocol: a small, purpose-built medicines fridge will need a simpler study than a multi-zone ambient warehouse — fewer sensors, a shorter duration — but the requirement for a completed, documented mapping exercise before product is stored applies to both. The study protocol should justify its sensor count and placement in the documentation.

EU GDP 2013/C 343/01 requires records to be retained for at least five years — or for the period stated in national legislation if that is longer. The Human Medicines Regulations 2012 set a statutory minimum of five years for wholesale dealer records, and MHRA inspectorate guidance applies that same five-year minimum to temperature monitoring data specifically. Your Responsible Person and quality system should define the retention schedule for your operation, including any product-specific obligations that may extend it.