Avertissement ! Le contenu de cette page est disponible uniquement dans les langues suivantes: Anglais - Italien
Optional Requirement for Software/Hardware Control System
GAMP5 (Guide for Validation of Automated Systems)
The automation compliance to GAMP5 is autocertify from Comecer following a development sequence of the project called “Life cycle“; This autocertify is done by preparing the following documents, that describe the functional charateristic of the Hardware and the test for its validation:
The compliance of software to the regulation CFR21 part11 is autocertify from Comecer following a documented analysis of the regulation requirements; Comecer describes how this requirements are applied in software development. Also the requirements of CFR21 part11 are validated with a test protocol (STS Software Test Specifications).
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
✖
Cookie settings
In the absence of your explicit consent, we will not track any type of cookies - except Technical cookies that are necessary for the operation of the site - in relation to navigation on the Comecer site.
Before expressing your preferences regarding your consent to the collection of statistical and practical or customization cookies, we invite you to read the Comecer Cookie Policy available through the following link:
Information on the processing of personal data
Technical cookies are technical cookies whose use does not require the user's consent. These cookies are essential to enable you to navigate a website and use its full functionality. Without these cookies, which are absolutely necessary, a website could not provide certain services or functions and browsing would not be as easy and easy as it should be. A cookie of this type is also used to store a user's decision on the use of cookies on the website. Technical cookies are essential and cannot be disabled using this feature. In general, however, cookies can be disabled completely in your browser at any time.
Statistical Cookies
Statistical cookies are used to monitor the performance of the site, for example, to know the number of pages visited or the number of users who have viewed a particular section. The analysis of these cookies generates anonymous and aggregated statistical data without any reference to the identity of the site's visitors. They are also useful to evaluate any changes and improvements to be made to the site itself.
Targeting cookies
Targeting cookies are cookies set by third parties such as YouTube, Facebook, Twitter. These cookies track your behavior such as playing videos or what tweets you have already viewed. If you do not consent to these cookies, you will not be able to watch videos on this website or use the social sharing feature. These cookies may be used by the cookie provider to create a profile of your interests and show you relevant advertisements on other sites. They do not directly store personal information but are based on the unique identification of your browser and Internet device.
More information
Technical Cookies
Technical cookies are technical cookies whose use does not require the user's consent. These cookies are essential to enable you to navigate a website and use its full functionality. Without these cookies, which are absolutely necessary, a website could not provide certain services or functions and browsing would not be as easy and easy as it should be. A cookie of this type is also used to store a user's decision on the use of cookies on the website. Technical cookies are essential and cannot be disabled using this feature. In general, however, cookies can be disabled completely in your browser at any time.
Statistical Cookies
Statistical cookies are used to monitor the performance of the site, for example, to know the number of pages visited or the number of users who have viewed a particular section. The analysis of these cookies generates anonymous and aggregated statistical data without any reference to the identity of the site's visitors. They are also useful to evaluate any changes and improvements to be made to the site itself.
Targeting cookies
Targeting cookies are cookies set by third parties such as YouTube, Facebook, Twitter. These cookies track your behavior such as playing videos or what tweets you have already viewed. If you do not consent to these cookies, you will not be able to watch videos on this website or use the social sharing feature. These cookies may be used by the cookie provider to create a profile of your interests and show you relevant advertisements on other sites. They do not directly store personal information but are based on the unique identification of your browser and Internet device.
Radiopharma
Pharma
ATMP Thérapie génique et cellulaire
Services
The automation compliance to GAMP5 is autocertify from Comecer following a development sequence of the project called “Life cycle“; This autocertify is done by preparing the following documents, that describe the functional charateristic of the Hardware and the test for its validation:
The compliance of software to the regulation CFR21 part11 is autocertify from Comecer following a documented analysis of the regulation requirements; Comecer describes how this requirements are applied in software development. Also the requirements of CFR21 part11 are validated with a test protocol (STS Software Test Specifications).
