Measure How Quality and Regulatory Procedures Are Performed in Practice
Pyze measures the steps performed across quality management, document control and regulatory systems, so cycle time, procedure adherence and inspection preparation effort can be evidenced. Pyze does not make quality or compliance determinations.
Structural facts about the method and its timing. Results depend on the number of systems involved and on how much of the work occurs outside the quality management system.
Quality and regulatory leaders are accountable for deviation and CAPA timeliness, controlled documents, audit evidence and inspection readiness. Quality management systems record the state of each record and its approvals. They do not record the work performed to move it forward: the retrieval of supporting information from other systems, the document review and cross-referencing, and the assembly of evidence. Pyze measures that work as execution metadata. Pyze does not evaluate product quality, assess compliance, or determine whether a deviation, CAPA or document meets a requirement. Those determinations remain with your quality and regulatory functions.
Questions Asked of This Role
Deviation and CAPA cycle times that exceed targets, with delay spread across investigation, review and approval steps
Document and SOP control workloads, including periodic review, change control and cross-referencing of related documents
Audit evidence that must be assembled from several systems for each request
Adherence to procedures within validated systems, including the steps performed outside them
Effort required to prepare for inspections, which recurs and competes with routine quality work
Key Questions and Outcomes
Each question shows the answer available today, why that answer is insufficient, and what changes with Pyze.
Where does the time go in deviation and CAPA handling?
Cycle time by stage from the quality management system and a review of overdue records.
Stage durations show where a record waited. They do not show the work performed within a stage or the effort spent retrieving information from other systems.
Observed steps and effort within each stage across the quality system and the applications around it, so the contributors to cycle time are specific and can be addressed without altering the validated record.
How consistently are procedures followed in practice?
Training records, internal audits and sample-based reviews of completed records.
Training records show that procedures were read. Audits and sampling cover a limited portion of the work and review the recorded output.
The documented procedure compared with the observed sequence of steps across all in-scope work, reported at the process level, so variation is quantified. Whether a variation is acceptable remains a determination for your quality function.
How much effort does inspection readiness require?
Estimates from the team that prepared for the last inspection.
Estimates are retrospective and depend on recollection. They do not show which evidence retrieval and document preparation steps consumed the effort.
Measured effort for evidence retrieval and preparation activities, so the recurring workload can be sized and opportunities to prepare evidence in advance can be evaluated.
Engagement Sequence
Instrument the applications in scope, such as the quality management system, document control and supporting systems, under your validation and change control requirements. Baseline effort by process without changing the procedures.
Opportunities documented and sized across the five levers, including retrieval and cross-referencing steps that can be prepared in advance and steps that can be standardized.
Any change is implemented and validated by your teams under your quality system. Measurement continues so the effect on effort and cycle time is compared with the baseline.
Frequently Asked Questions
Does Pyze affect our validated systems? +
Pyze captures application interaction metadata: which application, which screen, the sequence and the timing. It does not capture keystrokes, field values, free text or screen contents. Your quality function determines whether and how the collector is assessed under your own computerized systems validation procedures.
Does Pyze make quality or compliance determinations? +
No. Pyze does not assess whether a deviation was handled correctly, whether a CAPA is effective, or whether a document or process is compliant. It reports how work is performed and how it varies. Interpretation and any quality or regulatory decision remain with your qualified personnel.
Can the measurement be used as evidence in an inspection? +
It can be provided as supporting information on how work is performed and how procedure adherence is monitored. Whether and how it is used in an inspection is a decision for your quality and regulatory leadership. Collection is limited to an explicit whitelist of business applications, identifiers are pseudonymous, and the unit of analysis is the process.