Today, the 21 CFR Part 11 standard applies to more and more sectors. It is therefore essential to choose a CMMS that is adapted, mobile and agile.
The pharmaceutical industry is a particular industrial activity, subject to numerous standards due to the health issues. These standards concern both the production of medicines itself and the traceability of all associated activities.
In terms of maintenance management, these constraints oblige companies in the pharmaceutical sector to comply with strict rules affecting all aspects of the activity, the Good Manufacturing Practices for drugs production, or GMP. These rules both apply to the quality of the maintenance itself as well as the monitoring and control of all the processes surrounding it.
In particular, GMP requires that a written record be kept of all work carried out on production tools and that maintenance of buildings and equipment be carried out regularly and efficiently. In addition, 21 CFR Part 11 of the FDA, the American government agency responsible for authorizing the marketing of drugs in the United States, imposes strict rules on electronic signatures, document traceability and audit trails.
As a result, companies in the pharmaceutical sector must equip themselves with the tools best suited to these constraints. In terms of maintenance management, only a next-gen CMMS such as Mobility Work allows them to meet this requirement while facilitating the work of maintenance technicians and improving their productivity.
Our CMMS solution has been designed to allow an easy management of user access rights and electronic signatures, but also to be able to provide quickly and easily complete audit trails in case of external audit in order to comply with a standard.
Moreover, the Mobility Work CMMS has many functionalities allowing the implementation of maintenance plans, whether it is curative, corrective, conditional, preventive or predictive. This last strategy is the most effective, thanks to the use of IoT, the Internet of things. Adapted to this technology, our application will allow you to anticipate breakdowns and limit machine downtime, which will improve your company’s productivity.
More generally, adopting a mobile CMMS facilitates the management of team planning, the entry of intervention reports and the consultation of technical documentation from any location, and the follow-up of maintenance plans. Usable without any specific training, our application has met with great success among maintenance technicians in the pharmaceutical and health sector because of its ease of use, which encourages them to scrupulously respect maintenance standards and traceability of interventions.
Discover the many advantages of the next-gen CMMS for the pharmaceutical industry by reading our articles!