QMS Pharma
Quality today. Compliance always. Better tomorrow.
A closed-loop quality management system connecting deviations, CAPA, change control, audits, complaints, risk, and training — the same depth of quality event management enterprise eQMS platforms offer, built for regional pharmaceutical manufacturers.
Core Modules
One connected system for every quality process — instead of a dozen disconnected spreadsheets and shared folders.
Deviation Management
Log, investigate, and close deviations with structured root-cause analysis and full traceability back to the originating event.
CAPA Management
Closed-loop corrective and preventive actions that can be launched directly from a deviation, complaint, audit finding, or nonconformance.
Nonconformance Management
Identify, evaluate, and disposition nonconforming materials and products, with automatic escalation to CAPA when warranted.
Change Control
Route change requests through configurable, GMP-aligned approval workflows with documented impact assessment.
Document Control
Version-controlled SOPs, policies, and records with configurable authoring, review, and approval workflows.
Training Management
Whenever a linked SOP changes, affected employees automatically receive a new training task — training-on-change, built in.
Supplier & Vendor Quality
Track supplier qualification, audits, and quality performance history alongside your internal quality data.
Quality Risk Management
Apply a structured, ICH Q9-aligned risk methodology to change control, deviations, and supplier decisions.
Audit Management
Plan internal and external audits, track findings, and manage responses through verified closure.
Complaint Handling
Capture, investigate, and trend customer and market complaints in line with regulatory expectations.
Electronic Signatures & Audit Trail
Attributable, time-stamped e-signatures and a complete, exportable audit trail on every quality record.
Configurable Workflows
No-code workflow and form configuration so your quality processes match how your organization actually operates.
Quality Dashboards & Trend Analytics
Live KPIs on open CAPAs, overdue actions, deviation trends, and audit findings for management review.
Ready For Compliance
One Quality System, Every Regulatory Framework
QMS Pharma replaces scattered spreadsheets and paper trails with a connected quality management system that quality managers, QA reviewers, and inspectors can all trust.
- Close the loop on deviations and CAPAs with automated escalation and reminders
- Cut audit preparation time with instantly exportable, timestamped records
- Keep every SOP and controlled document under version control
- Trend complaints and deviations to catch systemic issues earlier
- Give leadership a live view of quality KPIs across every site
QMS Pharma FAQ
Yes. Any deviation, complaint, audit finding, or nonconformance can trigger a linked CAPA directly, carrying its originating record and root-cause data forward so the two stay traceable to each other.
Yes. When a document under Document Control is revised, every employee linked to it is automatically assigned a new training task, so training-on-change happens without a manual reminder process.
Yes. Quality Risk Management follows an ICH Q9-aligned methodology and can be applied directly to change control requests, deviations, and supplier qualification decisions.
QMS Pharma is built integration-ready, so quality events raised in CMMS Pharma or PackProof QA can be connected to the same CAPA and change control workflows as your integration plan calls for.
CMMS Pharma
Uptime today. Compliance always. Performance tomorrow.
A closed-loop computerized maintenance management system connecting preventive maintenance, calibration, change control, spare parts, and equipment qualification — the same depth of asset and maintenance management enterprise CMMS platforms offer, built for regional pharmaceutical manufacturers.
Core Modules
One connected system for every maintenance process — instead of paper logbooks, spreadsheet PM schedules, and disconnected calibration records.
Preventive Maintenance
Schedule and track recurring PM tasks by calendar, meter reading, or usage, with automatic reminders before a task falls overdue.
Corrective Maintenance
Log breakdowns and raise work orders in one step, with full history of parts used, labor hours, and downtime tied to each asset.
Calibration Management
Track calibration due dates, certificates, and tolerances for every instrument, with automatic escalation when a calibration lapses.
Downtime Tracking
Capture planned and unplanned downtime by cause, with MTBF and MTTR rolled up automatically at the asset and line level.
Asset Register & Lifecycle
A single record for every piece of equipment — specifications, maintenance history, warranty status, and lifecycle stage.
Spare Parts Inventory
Track stock levels, reorder points, and part-to-asset links so a work order never stalls waiting on an unordered part.
Vendor & Contractor Management
Manage approved service vendors, contractor visits, and third-party calibration or repair records against every asset.
Change Control Register
Route equipment and process changes through configurable, GMP-aligned approval workflows with documented impact assessment.
Equipment Qualification (IQ/OQ/PQ)
Plan, execute, and store installation, operational, and performance qualification protocols against every regulated asset.
CAPA Management
Launch corrective and preventive actions directly from a breakdown, deviation, or failed calibration, closed loop to resolution.
Electronic Signatures & Audit Trail
Attributable, time-stamped e-signatures and a complete, exportable audit trail on every work order and maintenance record.
GxP Compliance Reports
Generate inspection-ready maintenance and calibration reports mapped to GMP, GAMP 5, and ISO 55001 expectations.
OEE & Maintenance Dashboards
Live KPIs on open work orders, overdue PM, downtime trends, and overall equipment effectiveness for management review.
Ready For Compliance
One Maintenance System, Every Regulatory Framework
CMMS Pharma replaces paper logbooks and spreadsheet PM schedules with a connected maintenance system that engineering, QA, and inspectors can all trust.
- Close the loop on PM and calibration schedules with automated reminders and escalation
- Cut audit preparation time with instantly exportable, timestamped maintenance records
- Keep every equipment qualification protocol under version control
- Track downtime and MTBF/MTTR trends to catch reliability issues earlier
- Give leadership a live view of maintenance KPIs and OEE across every site
CMMS Pharma FAQ
Yes. Any corrective maintenance record, breakdown, or out-of-tolerance calibration can trigger a linked CAPA directly, carrying its originating record forward so the two stay traceable to each other.
Yes. Every instrument’s calibration due date is tracked automatically, with reminders sent ahead of the deadline and escalation if a calibration lapses without action.
Yes. The system is built with a GAMP 5-aligned computerized system lifecycle in mind, alongside 21 CFR Part 11 electronic signatures and Annex 11 data integrity controls.
CMMS Pharma is built integration-ready, so equipment failures or calibration issues can be connected to the same CAPA and change control workflows your integration plan calls for in QMS Pharma or PackProof QA.
PackProof QA
Error-free artwork today. Compliance always. Confidence tomorrow.
A closed-loop artwork and print inspection system connecting visual comparison, OCR text verification, barcode validation, and change history — the same depth of packaging quality control enterprise artwork QA platforms offer, built for regional pharmaceutical manufacturers and packaging converters.
Core Modules
One connected system for every artwork inspection process — instead of a light table, a spreadsheet sign-off log, and a folder of PDF revisions.
Artwork Comparison
Overlay a new artwork file against its approved master and flag every visual difference automatically, pixel by pixel.
Alignment & Registration Check
Detect print skew, misregistration, and scale drift against die-lines and reference marks before a job goes to press.
Color & Print Verification
Check spot and process colors, tints, and overprints against approved color standards for every SKU and market variant.
Barcode & Datamatrix Verification
Grade barcode and 2D datamatrix quality and decode accuracy against GS1 requirements before packaging is released.
OCR Text Extraction
Pull every line of copy off the artwork automatically, including dosage text, warnings, and multi-panel layouts.
Text Comparison & Proofreading
Compare extracted copy against the approved source text and highlight every insertion, deletion, and character change.
Multi-Language & Script Support
Verify Arabic, English, and other regional scripts side by side for GCC market variants of the same artwork file.
Approval Workflow
Route artwork through configurable review and sign-off stages, with automatic escalation when a review stalls.
Version Control & Artwork History
Keep every revision of every artwork file on record, with a clear trail of what changed between versions and why.
Electronic Signatures & Audit Trail
Attributable, time-stamped e-signatures and a complete, exportable audit trail on every inspection and approval.
Inspection Reports
Generate a discrepancy report for every job automatically, ready to attach to the batch or artwork approval record.
Batch & Job Management
Group artwork files by product, SKU, and market variant so every job’s inspection status is visible at a glance.
Dashboards & Analytics
Live KPIs on inspection throughput, discrepancy rates, and first-pass approval trends across every printer and SKU.
Ready For Compliance
One Inspection System, Every Regulatory Framework
PackProof QA replaces manual light-table checks and spreadsheet sign-off logs with a connected inspection system that packaging QA teams and printers can all trust.
- Close the loop on artwork revisions with automated version comparison and sign-off
- Cut inspection time with side-by-side visual and text discrepancy highlighting
- Keep every approved artwork file under version control with full history
- Catch barcode, color, and registration errors before they reach the press
- Give leadership a live view of inspection throughput and error rates across every job
PackProof QA FAQ
Yes. Text is extracted from both versions via OCR and compared line by line, with every insertion, deletion, and character-level change flagged for review.
Yes. Arabic, English, and other regional scripts can be verified side by side, which matters for GCC market variants that carry bilingual packaging text on the same artwork.
Yes. Barcode and 2D datamatrix quality and decode accuracy are checked against GS1 requirements before a packaging job is released to print.
PackProof QA is built integration-ready, so an artwork discrepancy can be connected to the same CAPA and change control workflows your integration plan calls for in QMS Pharma or CMMS Pharma.
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