APQR consumes months of manual effort
Annual Product Quality Reviews are assembled by hand from scattered records weeks after the period closes — expensive, error-prone, and stale the moment they're printed.
Industry solution
Pharma & Medical Devices
Zometric automates Continuous Process Verification and the Annual Product Quality Review for regulated pharma and medical-device manufacturers — real-time streaming data, live control charts and capability stats, an always-audit-ready living document, and 21 CFR Part 11 audit trails on every action.
Key standards
- ICH Q10
- CPV
- APQR
- 21 CFR Part 11
- 21 CFR 820
- ISO 13485
- Audit trail on every action
- 21 CFR Part 11Audit trail on every action
- CPV streaming, not months-late
- Real-timeCPV streaming, not months-late
- APQR document, always audit-ready
- LivingAPQR document, always audit-ready
- Harmonized batch records
- Multi-plantHarmonized batch records
Pharma and medical-device quality runs on ICH Q10, 21 CFR Part 11, 21 CFR 820 and ISO 13485 — and on the resource-intensive APQR and CPV obligations that come with them. Traditional APQR means months-late manual consolidation, offline capability studies and a static PDF. Zometric replaces that with automated real-time data collection, live SPC and capability statistics, and a dynamic APQR that is always inspection-ready. Every action is captured in a 21 CFR Part 11 audit trail with electronic signatures and role-based access, so the system holds up to FDA, EU GMP and MHRA scrutiny. Capability reporting and batch records can be harmonized across multiple plants and countries from a single backbone.
The reality on the floor
What slows Pharma & Medical Devices quality and uptime
Compliance evidence trapped on paper
Batch records, capability studies and deviations live in binders and spreadsheets. Producing a clean audit trail for an inspector is a fire drill, not a query.
Process verification is offline and late
Capability is studied after the campaign, not monitored during it. Drift that should trigger CPV review surfaces only in the next periodic study.
Qualified equipment released without control
GMP equipment needs IQ/OQ/PQ and controlled PM, but maintenance and production scheduling rarely talk — assets get used before requalification sign-off.
How Zometric helps
The platform, mapped to Pharma & Medical Devices
Each capability is delivered by a module you can adopt on its own and expand from.
Automated CPV & APQR
Continuous Process Verification with live control charts and capability, and an APQR that is a dynamic living document — always current, always audit-ready, digitally archived instead of printed.
Delivered byCPV & APQR21 CFR Part 11 SPC & traceability
Browser-based control charts and capability with electronic signatures, audit trails, role-based access and time-stamped data linking every point to batch, operator, inspector and gauge.
Delivered byIn-Process Quality & SPCGauge & MSA under control
Calibration scheduling, certificate management and AIAG-format MSA with full calibration history and audit trails — supporting ISO 13485 and 21 CFR 820 measurement requirements.
Delivered byGauge & MSAGMP maintenance with qualification locks
Preventive maintenance with IQ/OQ/PQ workflows; assets under maintenance auto-lock from production scheduling and release only after work-order close and qualification approval.
Delivered byMaintenanceModule mix
Where Pharma & Medical Devices teams start
One data backbone — begin with one module and add the rest as you scale.
Continuous Process Verification & APQR
Built for regulated pharma. Automates the most resource-intensive compliance activities.
Explore module →In-Process Quality Intelligence & SPC
Catch process deviations before they become defects.
Explore module →Gauge Management & MSA
Ensures measurement integrity across all sites and instruments.
Explore module →Maintenance Management
Full-featured CMMS built for manufacturing, with predictive analytics.
Explore module →Standards & compliance
Built for the standards Pharma & Medical Devices is audited against
- 21 CFR Part 11
- Electronic records and signatures, audit trail on every action — built in, not bolted on.
- ICH Q10 / CPV
- Continuous Process Verification with live monitoring replaces months-late periodic studies.
- APQR
- Annual Product Quality Review automated as a dynamic, always-current living document.
- 21 CFR 820 / ISO 13485
- Medical-device QMS measurement, traceability and gauge-control requirements covered.
FAQ
Pharma & Medical Devices — frequently asked questions
Is Zometric 21 CFR Part 11 compliant?
Yes. Audit trails, electronic signatures, role-based access controls and time-stamped, tamper-evident records are built in across the platform. The CPV & APQR, SPC and Gauge modules are all designed for FDA, EU GMP and MHRA inspection.
How does Zometric automate the APQR?
Data is collected in real time as batches run, control charts and capability statistics update continuously, and the APQR is generated as a dynamic living document rather than a static PDF assembled months later. It stays audit-ready year-round and is archived digitally.
Can it harmonize quality across multiple plants?
Yes. Each plant runs its own instance and corporate quality gets a consolidated, standardized view — the same SPC, capability reporting and batch-record structure across sites and countries, which is what multi-site inspections expect.
Does it support medical devices as well as pharma?
Yes. The same SPC, MSA and traceability stack supports ISO 13485 and 21 CFR 820 measurement, gauge-control and capability requirements for medical-device manufacturing.
Start with your line
See Zometric on your Pharma & Medical Devices data
A 30-minute discovery call maps the right modules and standards to your factory — then a short pilot proves it on your real data.