The Software for Compliance with Cosmetics GMP ISO 22716

Cosmetri GMP is the only software application designed specifically for ISO 22716 compliance. This international standard has been adopted, among others, by the ICCR (US, EU, Japan and Canada) and ASEAN countries. Our existing customers will testify, that using Cosmetri GMP reduces cost, saves time and  accelerates the process of ISO certification.

The ISO 22716 standard requires a comprehensive approach and quality management system for those engaged in the manufacturing, packaging, testing, storage, and transportation of cosmetic products.

Cosmetri GMP is a turnkey solution enabling rapid deployment and minimal disruption to your business. Features of the software include:

  • Rapid deployment – be operational within 2-3 days
  • 30 SOP templates for ISO 22716
  • EDMS for GMP
  • Department and role-based user management
  • Audit logs
  • Dedicated database and FTP
  • Data backup

 

  • Comprehensive coverage of ISO 22716
  • Optimized for tablet and PC devices
  • Email notifications
  • Integrates with Product Manager, or standalone
  • Scalable for any company size
  • Export full document archive
  • Training included (see plan details)

 

ISO 22716 GMP compliance software features

Cosmetri GMP includes the following:

Internal Audits

Form-based audit questionnaires cover every section of ISO 22716. Tablet-optimized for easy on-premise inspections and upload of photographic evidence. Review associated GMP documents and report issues requiring a CAPA response.

CAPA Issue Management

Report and track risk-assessed deviations throughout every aspect of the business workflow. Issues can be escalated to require a CAPA or SCAR corrective action. Authorized users can participate in a discussion to resolve each issue.

EDMS for GMP

Full electronic document management for ISO 22716, including SOP and WI management. 30 included SOP templates. Associate a GMP document with any item. Supports e-signed PDF documents. Export complete document archive.

Product Recalls

Template-based recall management with mail-merge features for efficient generation of recall documents. Track send/receive history, import customer/distributor sales data and manage communication with recall authorities. View level of completion and to-do list.

Customer Complaints

Streamline your complaints process to achieve higher customer retention, while improving productivity and reporting. View complaints by customer, product, batch, status and assessed risk. Associate a complaint with a SUE or OOS.

Supplier Reviews

Automate the GMP review process for suppliers and sub-contractors, including supplier document management. Supports supplier-type Issues with required SCAR resolution. Risk-assess your suppliers and improve supply chain efficiency while ensuring compliance.

SUE Management

Manage undesirable (UE) and serious undesirable effects (SUE), linking any case with an OOS, Product Recall or Customer Complaint. Generate an SUE notification report, including EU-compliant PDF report format. Easy notification to the local authority.

Reporting & KPIs

View key statistics and reports and assess the current risk level of open items. Gain insights into your company’s performance and demonstrate evidence of continual improvement. Access all audit logs, change request history and other GMP/QMS data.

Locations

Manage locations such as storage facilities, washrooms, laboratories and production areas. Apply checklists for routine maintenance and cleaning. Associate internal audits and risk-assessed CAPA issues with any location.

Equipment

Manage equipment items and optionally associate with locations. Apply checklists for routine maintenance and cleaning. Associate internal audits and risk-assessed CAPA issues with any equipment item..

Staff Management

Efficient administration of staff and permissions using department/role-based logic. View user activity logs and set chains of command. Out-of-the-box configuration for ISO 22716 with the option to add custom departments and roles.

OOS Investigations

Report an out-of-specification for any product formula, raw material, or manufactured product batch. Complete Stage 1 to identify associated tests. Escalation to Stage 2 requires re-testing with resultant CAPA and conclusions.

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