MITIM is a pharma manufacturing company part of the leading CDMO Recipharm global network, specialized in beta lactams antibiotics and injectable sterile solutions cGMP production.
EU-GMP and FDA approved, MITIM's Brescia site is also ISO 14001 and ISO 45001 certified.

MITIM's needs
In its continuous attention to security and safety, MITIM needed to control accesses to its multiple production facilities, ensuring that only authorized personnel could access the premises while preventing cross-contamination, in respect of regulatory requirements, specifically of the new Annex1 guidelines, and of FDA CFR21 Part11.

Dos&Donts' solution
Dos&Donts delivered its Sigma platform equipped with the Acces Control plug-in ADEANT: it was installed in MITIM's Brescia, fully configuring the system to subsequently easily integrate other sites.
ADEANT enables the creation of weekly schedules, access rules, limited access zones, anti- passback zones and certificate lists with expiry dates for each specific user. The system also manages user badges/Rfids, allowing for easy identification and tracking of individuals accessing the facility.

Some of the main features:

1. Facilities structures creation: definition and representation of the facilities structures, including all solution components and accessories installed on site, enabling easy configuration of the access control system.
2. User management: role-based users management, allowing the administrator to define specific roles for each operator, making easier the implementation of the defined authorizations for all involved personnel
3. Log management: easy management of generated logs, so enabling easy monitoring of system activity and a precise identification of any access control issues.

Validation
The system has been validated according to GAMP guidelines and all the documents required for validation were easily produced, including user requirements, functional requirements, design specifications, IQ, OQ and PQ.
Flexibility and customizability of the solution allowed for easy configuration of the system, ensuring that it could meet MITIM's specific needs: great satisfaction of both Dos&Donts' and MITIM's teams!