Measure How Quality and Regulatory Processes Are Performed and Identify Where to Reduce Cycle Time
Pyze measures how deviation and CAPA handling, change control, document and SOP control, audit readiness, submission tracking and complaint handling are performed, and identifies where automation and AI agents apply.
Engagement archetypes from Pyze deployments across regulated operations rather than a single named account. Pyze measures how work is performed and does not assess the content of any record.
Quality and regulatory teams manage records of record in a quality management system, a document management system and a regulatory information system, and the work around those records is performed in email, spreadsheets and shared trackers. Deviation investigations, CAPA effectiveness checks, change impact assessments, periodic SOP reviews and inspection preparation each involve assembling evidence from several systems. Pyze measures that work. Pyze does not make quality, regulatory or compliance determinations.
Common Findings in Regulatory and Quality Operations
Four patterns that recur across engagements, each shown with the measurement and the resulting change.
Deviation investigations take longer than the target closure period, and the investigator assembles batch, equipment and prior event history from several systems.
AgentifyPyze measures the time an investigator spends in the quality system, the manufacturing and laboratory systems and spreadsheets for each deviation type. The evidence gathering steps that repeat across deviations of the same category are identified.
Related history is assembled for the investigator at the time the deviation is opened, so the investigation time is directed to root cause analysis.
Change controls are routed to many functional reviewers, and the same impact questions are asked of each change.
SimplifyPyze measures the elapsed time at each reviewer and the rework between initiation and approval. The change types where the reviewer set and the impact assessment are consistent are identified.
Review routing is tiered by change type and measured outcomes, so that low-impact changes follow a shorter path under the existing change control procedure.
Periodic SOP reviews and training assignments are tracked in spreadsheets alongside the document management system.
AutomatePyze measures the effort spent reconciling document status, effective dates and training records across systems, and the number of manual follow-ups required to complete a review cycle.
Review due dates, status reconciliation and reminders are maintained from the system records, and document owners receive the work when it is due.
Preparation for an inspection or audit draws on the same people who run daily quality operations.
StandardizePyze measures how much time the preparation takes from daily operations, which records are requested most often and where they are retrieved from. The retrieval steps that repeat for each request are identified.
A documented retrieval path for frequently requested records is built from how the fastest team members locate them, which reduces the load on subject matter experts.
Opportunity Register
A sample register, sorted by the lever that resolves each opportunity. In an engagement, each line carries measured hours, a named owner and the evidence it was derived from.
Systems typically instrumented
Capture covers browser-delivered and thick-client applications, including virtualized estates, with no change to how anyone works.
Roles Involved
Instrumentation is configured per application rather than per person, so the population in scope is set during scoping and is not a deployment constraint.
How an Engagement Runs
Baseline, blueprint, transform, prove
The same four stages apply in every sector. The fourth stage repeats the baseline measurement, which makes the engagement an ongoing operating capability rather than a one-time report.
Baseline
What the work costs today, measured across every person and application.
Blueprint
Procedures, application rules and execution evidence, read as one target state.
Transform
Where each of the five levers applies, priced and owned.
Prove
The after state measured against the baseline, using the same method.
Frequently Asked Questions
Does Pyze make quality, regulatory or compliance determinations?
What data does Pyze collect?
We already report deviation and CAPA cycle times from our quality system. What does this add?
Does measurement affect our validated systems?
Associated Titles
Industries
Other functions
Related
Start with a measured baseline
Six weeks from instrumentation to a priced opportunity register, and the baseline stays in place so later quarters are measured rather than re-estimated.