Cosmetri GMP FAQs
The easy way to get answers to the most frequently asked questions.
- Can the same user account access both the Cosmetri GMP and Product Manager?Yes, however a user seat must be available in both applications and the user granted access by your Administrator. User seats are subscribed separately for Cosmetri GMP and Product Manager when logged in as the Admin user. For example, if you require 10 users to access both Product Manager and Cosmetri GMP, you will require a total of 20 user seats. Assuming that you have three included user seats in your Product Manager Enterprise Annual plan and five included user seats in your Cosmetri GMP plan, you would therefore need to subscribe a total of 12 additional user seats (seven in Product Manager and five in Cosmetri GMP). Once granted access by your Administrator, a user may log in and switch seamlessly between the two applications (left menu, top). Additional user seats in Product Manager require the Product Manager Enterprise Annual plan.
- Do I need to also be subscribed to Product Manager to access Cosmetri GMP?
Cosmetri GMP does not require subscription to Product Manager. If you are subscribed to the Product Manager you can access both applications within the same interface, provided a user seat is available in both. This has the advantage of enabling items in the Product Manager such as suppliers, customers, products, formulas, manufacturing orders (product batches) and tests to be selected and associated with GMP functions including OOS investigations, Product Recalls and Customer Complaints. In future versions, further integration options and functionality will be available if subscribed to both applications.
- Is training included in the Cosmetri GMP subscription?
Yes – please refer to the plan you are subscribed to. Additional training can be provided by purchasing support hours in advance. For details click here.
- How can I subscribe additional Cosmetri GMP user seats?
Log in as the Admin user and under 'Cosmetri GMP Plan' (user menu, top right) you can subscribe additional user seats.
User seat subscriptions are tied to the renewal date of your main plan. For example, if your Cosmetri GMP annual plan subscription starts on Jan 1 and you subscribe 10 additional user seats on Feb 1, you will be billed 11/12th of the annual cost, with the additional user seat subscription then billed the following Jan 1 at the full annual price.
Please note, that a user seat subscription is specific to one application – therefore if you require a user to be able to access both applications, they will require two user seats, one in Product Manager and one in Cosmetri GMP.
- How does Cosmetri GMP manage e-signing of documents?
Cosmetri GMP requires upload of GMP documents such as SOPs and WIs in PDF format. The in-application PDF viewer retains the integrity of the e-signature envelope and locks documents from editing. Uploaded documents can therefore be pre-signed, either physically or using a digital signing service. Check with the appropriate authority about validity of digital signatures according to any local regulations and interpretations of GMP ISO:22716.
- If a member of staff leaves my company, how should I transfer their account to the new person?Management of personnel changes is simple using Cosmetri. Your Administrator may permanently deactivate a user account, thus ‘freezing’ it and retaining all historical user log activity and related data. Since this action is not reversible, you should only use this option when a staff member permanently leaves your organization. A user seat is released, enabling a new user account to be created. For traceability and GMP compliance, you should only provide account access to a single person and never share accounts. In Cosmetri GMP you must assign and department/roles from a user account, before you can deactivate it. This ensures that all permissions and items associated with the deactivated user account are transferred seamlessly to other staff members. For further information, please refer to the Cosmetri GMP guide.
- Is Cosmetri GMP FDA Title 21 CFR Part 11 and EU Annex 11 compliant?
FDA Title 21 CFR Part 11 covers regulations for the management of electronic records and use of electronic signatures. Cosmetri GMP is designed for compliance with ISO:22716 covering cosmetic products only and is therefore not covered by this regulation.
EU Annex 11 goes beyond the FDA 21 CFR Part 11 to cover integrity of system operations and information stored in the system. Likewise, this regulation does not apply to cosmetics products. Nevertheless, we refer to these regulations as ‘best practice’ guidelines in how we design and implement our software and are committed to ever closer alignment with these standards.
- Is there a free trial version of Cosmetri GMP?
Yes, you are welcome to trial the software for free for 14 days. The same trial account can be used to test Cosmetri GMP and Product Manager together or select only one of application to trial, if preferred. We recommend that you receive a free online demonstration of the Cosmetri GMP before starting the software trial. To apply click here
- Is there a user manual for learning Cosmetri GMP?
Yes, you can access under the user menu (top right) when logged in to the application, or click here.
- What is an Administrator account?
The Administrator (Admin) account has access to user management, default settings, billing, payment history and subscription options. If you are subscribed to both Cosmetri GMP and Product Manager, the same Admin account is used for both. Switch to the required application and then open the user menu (top right) to manage the settings for the application.
In all Cosmetri GMP and Product Manager accounts created after 15 April 2019, the Administrator account is restricted to only these functions and is not a normal user. Product Manager customers who subscribed before this date may continue to use the same Administrator account and access all features of the Product Manager. This Admin user therefore is considered as one user seat.
We recommend that the Admin account is operated only by an authorized staff member and the associated roles and responsibilities clearly defined in your staff training and SOP documents. Staff members with access to Cosmetri GMP and/or Product Manager should be instructed in the first line to contact their Admin if they have questions regarding user management, permissions or experience any problems with accessing the software.
- Where are the data and documents I upload to Cosmetri GMP stored?
Your data and documents are transmitted and stored securely on our servers, located in Germany. Scheduled backups of your data are stored on a separate backup server. Your Admin may at any time download a complete .zip archive of all your Cosmetri GMP documents.