cosmetri GMP FAQs

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cosmetri GMP

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 GM and Product Manager. For example, if you require 10 users to access Product Manager and cosmetri GM, you will require 10 user seats in each. Once granted access by your Administrator, a user may login and switch seamlessly between the two applications.

cosmetri GMP does not require the 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 products, formulas, batches/lots and tests to be selected and associated with GMP functions including OOS investigations, Product Recalls and Customer Complaints. In future versions, greater integration and functionality will be available if subscribed to both applications.

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.

The number of included user seats is determined by your cosmetri GMP plan. If you require further user seats, you must either upgrade your plan or subscribe additional user seats. cosmetri GMP user seats are subscribed on an annual basis and can be purchased as single user seats or as packages of 5.

User seat subscriptions are tied to the renewal date of your main plan. For example, if your 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.

The application requires upload of GMP documents in PDF format. The in-application PDF viewer retains in 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.

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, it is recommended to only provide account access to a single user.

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.

cosmetri software runs in a standard web browser and can therefore be auto-translated using the Google Translate browser plug-in.  We recommend using Google Translate running in the Chrome browser. While this may not always be a perfect translation, it should be adequate for using the software in your preferred language.

Our software uses UTF-8 character encoding for maxmium compatibility any natural language (Coptic, Sinhala, Phonecian, Cherokee etc). You can therefore enter your data in cosmetri in your preferred language. Try it for yourself by taking a free trial.

Default text in the reports generated by cosmetri software will still be in the default English language. We may be able to install language-specific report templates for you. Please enquire for further details.

Our software guides can also be machine translated into most languages. Please ask us and we'll send you a copy of these in your requested language.

If you are interested in partnering with cosmetri GmbH as a local representative, including providing sales and support in your native language, please contact us.

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 or select only one of these if preferred. We recommend that you receive a free online demonstration of the cosmetri GMP before starting the software trial. To apply click here.

A user seat is required in an application (cosmetri GMP and Product Manager) for a user to be able to be granted access by your Administrator. Users that are permanently deactivated do not require a user seat so you will not pay anything for retaining data and user logs related to old user accounts. A user seat subscription is specific to each 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.

The Administrator account has access to user management, global settings, billing and subscription options. If you are subscribed to both cosmetri GMP and Product Manager, the same Administrator 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 accounts 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.

We recommend that the Administrator 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 Administrator if they have questions regarding user management, permissions or experience any problems with accessing the software.

Your data and documents are transmitted and stored securely on our servers, housed in Germany. Scheduled backups of your data are stored on a separate backup server. Your Administrator may at any time download a complete .zip archive of all your GMP documents.

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