Features for Compliance with Cosmetics GMP ISO 22716
Cosmetri GMP is a comprehensive, easy-to-use, cloud-based application for compliance with GMP ISO 22716.
Use Cosmetri GMP as a standalone application or integrate with Product Manager for maximum ISO 22716 compliance. Users can seamlessly switch between applications, provided a user seat is available in each application.
The following matrix shows the full range of GMP features available with these applications. 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.
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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✔+
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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✔+
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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 Location✔+
Associate Issue with Equipment✔+
Associate Issue with Customer Complaint✔+
Upload additional documents to Issue✔+
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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*✔+
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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)✔+
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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✔+
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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✔+
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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✔+
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Associate equipment item with location or sub-location✔
Manage checklists for routine maintenance and cleaning✔
Auto generated checklists e.g. on daily, weekly or monthly✔
Manage CAPA-based Issues for equipment items✔
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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✔+
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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✔+
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