cosmetri GMP Features for ISO 22716

Homecosmetri GMP Features for ISO 22716

cosmetri GMP is an off-the-shelf, easy-to-use and configurable solution that combines industry best practices with comprehensive features for adhering to the stringent requirements of GMP ISO 22716.

Use cosmetri GMP as a standalone cloud-based application or integrate GMP management with the Product Manager for full ISO 22716 compliance. Users can seamlessly switch between applications, provided a user seat is available.

The following matrix shows the full range of GMP features available with these applications. Click here to view all features of the cosmetri Product Manage. Features in the Product Manager with a indicate integration with cosmetri GMP if subscribed to both applications. Future releases of cosmetri GMP will provide further integration capabilities.




cosmetri
GMP

Product
Manager


Select Plan


Select Plan
View all Features

GMP Dashboard

Complete account GMP statistics
Logged in user summary - by risk level
Logged in user summary - by item type
Logged in user summary - by item status
Logged in user summary - by date added
Click to open item from Dashboard

Internal Audits

Covers all sections of ISO:22716
Customize ISO:22716 sections covered by audit
Tablet mode for on-location auditing, inc. photo upload
Warning if audit is incomplete - approval blocked
Warn of associated Issues before final approval
Full audit change log and user traceability
Appoint Internal Auditors
Set view-only access permissions for users
Email alerts to Head of Management and Internal Auditor
Create Issue from audit section/question
Set Internal Audit frequency
Email reminder and alert when new audit due to commence
Alert when current audit due to be completed
Review approved GMP docs related to each audit section
Final approval required by Head of Management
Archive of all completed Internal Audits

Issue Management

Organization-wide Issue reporting for effective QMS
CAPA required action to resolve issue
Set Issue risk level for QRM
Set users allowed to participate in discussion to achieve resolution
Set Issue Owner
Set Issue Manager
Associate Issue with GMP document(s)
Associate Issue with Supplier
Supplier Corrective Action Required (SCAR)
Associate Issue with Internal Audit question
Associate Issue with Customer Complaint
Upload additional documents to Issue

Departments & Roles

ISO:22716 departments and roles
Add custom roles and departments
Alert if required ISO:22716 role is not assigned
Role-base permissions
Transfer role between team members
User traceability and audit logging
Set chains of command
De-activate user to release user seat, retain all user log data
Add unlimited users*
Administrator can revoke user access
Grant existing Product Manager user access*

GMP Doc Management

4-level folder structure for GMP
30 SOP templates for ISO:22716
Manage GMP docs inc. SOPs, WIs, Forms, etc
Add custom GMP doc types
Document version control
Set optional custom version ID
Auto-set old versions as superseded
Associate GMP docs with items
'Freeze' associated document versions
Custom UID for referencing master document
Approval management with document statuses
Set GMP document review cycle
Set users who may approve documents
Set users who may upload documents
User document activity log
Set document recipients
Email document recipients
Require recipient read confirmation
Set new version as minor change only
Search and filter documents
GMP document review integral to Internal Audit
Export document archive as .zip
Supplier GMP docs
Optionally upload e-signed PDFs
In-application document viewer (PDF)

Product Recalls

Trigger product recall from Issue, OOS, UE/SUE or Customer Complaint
View all recall history and statuses
Associate Product Recall with product/formula/batch in Product Manager
Associate with manually entered product/formula/batch
Associate recall procedure with GMP document(s)
Set recall Supervisor and Deputy Supervisor
Recall default templates for ISO:22716
Customize recall templates
Check-list and level of completion status
Manage Customer/Distributor recall activity
Apply bulk actions to all selected Customers/Distributors
Generate recall letters with mail-merge function
Generate recall return response with mail-merge function
Generate recall effectiveness questionnaire with mail-merge function
Review recall procedure as part of Internal Audit
Set custom recipients for email alerts
Set user permissions for recall management
Authorized users may participate in discussion for a Product Recall
Change log for Product Recall and all Customer/Distributor activity

Out of Specification (OOS) Investigations

Associate OOS with product/formula/batch in Product Manager
Associate OOS with manually entered product/formula/batch
Stage 1: check for analytical errors
Stage 2: perform repeat tests and enter conclusions and required measures
Select available test data entered in Product Manager
Repeat tests in Product Manager and associate with Stage 2
ISO:22716 standard procedure/checklists
Add custom items to checklists
Associate OOS with GMP document(s) e.g. SOP
Set risk level
Set status
Email alert to Supervisor upon report of OOS
Select affected product/formula/batch in Product Manager
Select affected sample group/test in Product Manager
Associate OOS with Customer Complaint
Generate Stage 1 and Stage 2 as signable PDF reports
Set authorization and permissions for Analysts
Withdraw OOS investigation - requires 'reason for withdrawal'
View/export change log

Customer Complaints

Manage Customers/Distributors
Associate with Customer/Distributor
Associate with product/formula/batch in Product Manager
Associate with manually entered product/formula/batch
Associate with OOS review
Associate with UE/SUE case
Set risk level
Set status
Associate with product/formula and batch no.
Withdraw complaint - requires 'reason for withdrawal'
Upload images
View/export change log

Authorities

Set Local authority recall coordinator
Associate Authority with SUE or Product Recall
Set contact person at the Authority
Set preferred method of contact
Optional URL for online contact/submission
View/export change log

UE/SUE Management

Associate UE/SUE with product/formula/batch in Product Manager
Associate with manually entered product/formula/batch
Escalate UE to SUE status
Set risk level
Associate with product/formula and batch no.
Appoint Supervisor
Set status
Associate with Customer Complaint
Associate with OOS
Associate with Product Recall
Associate documents/images
Generate SUE submission form (PDF) in EU format
Set Local authority recall coordinator
Set Competent Authority for notification
Associate with other Authorities
Email alert to Supervisor and designated staff

GMP ISO:22716 Features in Product Manager

Document management for compliance, including PIF
Confirm product is compliant with GMP ISO:22716
GMP compliance confirmation and statement included in PIF
In-process testing for manufactured product batches
Ensure adherence to manufacturing instructions
Records to confirm critical steps during manufacture, e.g. heating times, speeds, mixing times, etc.
Batch tickets generated, included in batch protocols
Approval change logs for raw materials and packaging
Approval change logs for formulas
Sequential manufacturing requires approval of each stage
Acceptable quality levels (AQLs) for critical, major and minor defects for product inspections
Final inspection and approval of packed-out products for release to market
QMS for received raw materials
QMS for retained samples, inc. stability testing
Formula versioning and approval statuses for change control
Product assessment, review and evaluation
Bar-coded sample labels for sample management
Comprehensive test reports
Optional printing of paper-records for all reports
Batch protocols for every manufactured product batch
Off-site storage/backup of electronic documents
Documentation and specification of raw materials, including management of CoAs
Documentation and specification of packaging items


* A user seat must be available for each user requiring access to the application. If a user requires access to both cosmetri GMP and Product Manager, a user seat in each application is required. Additional user seats can be subscribed when logged in as the Administrator, under 'Plan'.



cosmetri GMPTM

Select Plan





Product Manager

Select Plan

View all Features

Don’t Miss Out!

Get updates on new articles, webinars and other opportunities.
  • Exclusive webinar invites
  • New cosmetri releases and features
  • Special offers and event passes




I'm interested in:


cosmetri GmbH will use the information you provide on this form to be in touch with you and to provide updates and marketing. We will treat your information with respect. For more information about privacy practices click here. You can change your mind any time by clicking the unsubscribe link in the footer of an email you receive from us, or by contacting us at info@cosmetri.com. By clicking below, you agree that we may process your information in accordance with these terms.

MailChimp logoWe use Mailchimp as our marketing automation platform. By clicking below to submit this form, your acknowledge that the information you provide will be transferred to Mailchimp for processing in accordance with their Privacy Policy and Terms.