Loftware Cloud Compliance | Software for Label Compliance in Canadian Regulatory Industries

Product Loftware Cloud Compliance

Type Cloud-Based Validated Label Design & Barcode Software

Licensing Annual Subscription

Deployment Browser-Based and FDA 21 CFR Part 11 Compliant

Target Market Industries Regulated by Canada (Pharma, Medical Device, Biotech)

Availability Available in Canada through DuraFast Label Company

About Loftware Cloud Compliance

Loftware Cloud Compliance is the leading cloud-based labeling solution for Canadian highly regulated industries where labeling precision, validation, and audit preparedness are operational necessities and legal obligations. The flagship edition provides labeling that is fully compliant with FDA 21 CFR Part 11, EU Annex 11, and Health Canada guidelines, as well as offering complete validation documentation, electronic signatures, and extensive audit trails.

Cloud Compliance facilitates regulated cloud compliance with the agility and speed of cloud computing, providing the validated compliance infrastructure required for pharmaceutical and medical device labeling. This software is fully compliant with globally recognized labeling requirements, covering everything from pharmaceutical labeling to Class II medical device labeling and clinical trial material management.

What is Loftware Cloud Compliance?

Loftware Cloud Compliance is a fully validated, cloud-based enterprise labeling platform built for regulated industries and pre-configured for cloud deployment.

The latest iteration includes extensive support for validation, documentation of regulatory requirements, and compliance features that meet the most rigorous oversight specifications from Health Canada, FDA, and other worldwide regulatory agencies.

Key Capabilities

Achieve 21 CFR Part 11 Compliance: Complete electronic records and electronic signatures (ER/ES) with non-repudiation
Maintain Complete Audit Trails: Immutable logs of all user actions, label changes, approvals, and print jobs
Validate with Confidence: IQ/OQ/PQ documentation, test reports for every release, and validation acceleration packs
Ensure Data Integrity: ALCOA+ principles with prevention of data deletion, modification concealment, and back-dating
Manage Change Control: Controlled workflows requiring electronic approval for label modifications
Pass Regulatory Inspections: Yearly compliance release schedules with 3-month testing periods
Scale Validated Operations: Cloud flexibility with enterprise-grade security and compliance controls

Which Canadian Businesses Need Loftware Cloud Compliance?

Cloud Compliance is critical for Canadian organizations subject to regulatory oversight where labeling mistakes could trigger regulatory actions, lead to product recalls, or harm patients.

Pharmaceutical Manufacturers

Prescription drug manufacturers with DIN labeling and serialization requirements
Over-the-counter (OTC) medication manufacturers
Manufacturers of generic pharmaceuticals
Contract manufacturing organizations (CMOs)
Producers of active pharmaceutical ingredients (APIs)

Medical Device Companies

Class I, II, and III medical device manufacturers needing UDI compliance
Producers of in-vitro diagnostics (IVD) devices
Manufacturers of surgical instruments and implants
Companies providing medical equipment and supplies
Contract manufacturers and sterilization services

Biotechnology & Life Sciences

Manufacturers and distributors of vaccines
Processors of blood products and plasma
Developers of gene and cell therapies
Producers of biologics and biosimilars
Clinical research organizations (CROs)

Other Regulated Industries

Manufacturers of nutraceuticals and dietary supplements (cGMP compliant)
Cosmetics companies with drug-like claims
Manufacturers of tobacco and cannabis products
Any Canadian organization requiring validated computer systems for labeling

Key Features

Regulatory Validation

Validation Acceleration Pack: Ready-made documentation and protocols for IQ/OQ/PQ
Release with Test Reports: Validation documentation for every software release
Regulatory Compliance Release Schedule: Ongoing updates in compliance with regulations
3-Month Testing Period: Larger validated releases for major software updates

Electronic Records & Signatures

21 CFR Part 11 compliant ER/ES with signature and identity verification
Non-Repudiation: Cryptographic proof of signature
Intent of Signature: Proven signature of understanding and intent
Multi-Factor Authentication: Added security for signature and other important processes

Audit & Compliance

Complete Audit Trails: Every action is tracked and attributed to a user
Integrity of Electronic Records: Checksums and automatic timestamping
Regulatory Reporting: Compliance dashboards alongside reports ready for auditing
12-Year History: Extended retention of printed records to meet regulatory standards

Enterprise Features

Development, QA, and Production environments with validated change control
Additional Sandbox environments available for further validation testing
5 GB Secure Cloud Storage: For compliance and label documents
5 GB Cloud SQL Database: For regulated data storage
Priority Support: Included with Premium upgrade options

Loftware Cloud Editions Comparison

Understanding your compliance and operational needs will help you choose the most suitable software for your regulations and processes.

Cloud editions available: Designer vs Essentials vs Business vs Compliance

Get a Free 30-Day Trial

Test the validated functionality of Loftware Cloud Compliance with a free 30-day trial. No credit card is required to evaluate your electronic signature workflows, audit trails, regulatory compliance support, and UDI label creation.

Start your free trial today and see why Canadian pharmaceutical and medical device manufacturers are choosing Loftware for validated labeling operations.

Start Free Trial

Pricing for Loftware Cloud Compliance in Canada

Loftware Cloud Compliance follows a simple and transparent annual subscription model for small and large regulated operations. Here are the tiered pricing structures:

Cloud Compliance - Small Business

Loftware Cloud Compliance Pricing

SKU	Description	Annual Price (CAD)
Small Business Edition
NSCCSM001M	Loftware Cloud Compliance - Small (Base Subscription: Includes up to 3 printers, includes Standard Support)	$9,720.00
NSCCSA001M	Loftware Cloud Compliance - Small: Printer Add-on / printer / year	$1,170.00
NSCCSP001M	Loftware Cloud Compliance - Small: Platinum Support / printer / year	$144.00
NSCCSI001M	Loftware Cloud Compliance - Small: SAP Integration Bundle / printer / year	$171.00
NSCCOI001M	Loftware Cloud Compliance - Small: Oracle Integration Bundle / printer / year	$135.00
Large Business Edition
NSCCLX001M	Loftware Cloud Compliance - Large (Base Subscription: Includes up to 50 printers, includes Standard Support)	$53,910.00
NSCCLA001M	Loftware Cloud Compliance - Large: 5 Printer Add-on / 5 printers / year	$3,240.00
NSCCLP001M	Loftware Cloud Compliance - Large: Platinum Support / printer / year	$108.00
NSCCLI001M	Loftware Cloud Compliance - Large: SAP Integration Bundle / printer / year	$117.00
NSCCLO001M	Loftware Cloud Compliance - Large: Oracle Integration Bundle / printer / year	$99.00

Canadian Validated Labeling Partner: DuraFast Label Company

As your trusted source for Loftware Cloud Compliance in Canada, validated barcode software, and regulatory compliant label design solutions, DuraFast Label Company offers:

Authorized Loftware Cloud Compliance Subscriptions: Validated licenses with full documentation and support entitlement
Validation Expertise: Specialized knowledge of Canadian pharmaceutical, medical device, and biotechnology validation requirements
IQ/OQ/PQ Support: Support for the execution of installation qualification, operational qualification, and performance qualification
Consulting Support: Compliance strategies for Health Canada, FDA, and EU MDR regulations
Complete Software Portfolio: All editions of Loftware Cloud and NiceLabel solutions for on-premise hybrid validated environments
Validated Printers: GxP environment-calibrated thermal and color label printers
Validated Printer Supplies: Labels, ribbons, and materials compliant with FDA, Health Canada, and ISO standards
Post-Market Validation Services: Change control, periodic review, and auditing support
Canadian Pricing: CAD pricing and local stock eliminate cross-border pricing and regulatory challenges

Contact DuraFast Label Company to discuss validated labeling needs, arrange a compliance consultation, request your free trial, or purchase Loftware Cloud Compliance subscriptions.