The implementation of an efficient CMMS solution has become essential for companies in the pharmaceutical and healthcare industries in order to comply with current regulations while increasing productivity.
The pharmaceutical industry is a particular industrial activity, subject to numerous standards due to the health issues that accompany it. These standards concern both the production of drugs itself and the traceability of all associated activities. In terms of maintenance management, these constraints oblige pharmaceutical laboratories to comply with strict rules affecting all aspects of the activity, the Good Manufacturing Practices for drugs, or GMP. These rules concern both the quality of the maintenance itself and the monitoring and control of all the processes involved.
Consequently, the companies of the pharmaceutical sector must be equipped with the most adapted tools to these constraints. In terms of maintenance management, only a new generation CMMS such as Mobility Work allows them to meet this requirement while facilitating the work of maintenance technicians and improving their productivity in the various fields: pharmaceutical, chemical, healthcare industry, hospitals, health institutions…
Discover the functionalities of the CMMS Mobility Work created for the pharmaceutical and healthcare industry
21 CFR part 11, issued by the US FDA, describes very specifically the rules to be respected for the tracking, archiving and authentication of documents relating to the maintenance of machines involved in drugs intended for marketing in the United States. It requires strict and advanced management of access and user rights, logging of connections and accesses, and the definition of hierarchical schemes determining who is responsible for approving data on critical operations.
The rules set forth in this standard have important implications for maintenance management, making the use of an effective CMMS solution virtually unavoidable. Mobility Work CMMS software, compatible with the 21CFR11 standard of the American FDA, has advanced functions allowing to manage electronic signatures, in particular through various levels of approval, and to have access to the recording of all the maintenance actions carried out. In addition, all intervention reports, machine modifications and revisions are searchable and traceable.
In addition to two-factor authentication and SSO or SAML login procedures, Mobility Work CMMS provides a complete audit trail for Ultimate Plan Administrator users.
Mobility Work CMMS allows to trace the information concerning any action occurring on your network (account concerned, nature and time of the activity), and meets these requirements by keeping a trace of all the actions carried out on the documents related to maintenance for 10 years. In addition, in the event of an audit by an outside authority, the company can obtain, in just 72 hours, the audit trail of all its documents.
The rules applicable to the maintenance of drug production equipment are defined in the GMPs promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act, which is devoted to premises and equipment.
Maintenance procedures and documentation of interventions are subject to very strict rules. For example, a work order must be issued before any intervention. It must contain a lot of information such as the name of the equipment concerned, the description of the work to be done, the name of the intervention, the signature of the user department authorizing the action, etc. At the end of the intervention, the work order must be completed by specifying the possible modifications made, the products used and the parts that have been changed.
Finally, it must be presented to the maintenance manager for evaluation and signature, and then by the user department manager to allow the return to service. The work orders must be archived and remain accessible in case the same problem reappears.
Mobility Work CMMS software, which is compatible with the US FDA’s 21CFR11 standard, has advanced features to manage electronic signatures, including different levels of approval, and to have access to the record of all maintenance actions performed. In addition, all service reports, machine modifications and revisions are searchable and traceable.
Maintenance procedures must comply with numerous health regulations regarding cleaning conditions. In addition, tests must be performed and documented before the equipment is put back into service, and an evaluation must be made by the user department, the maintenance department and quality assurance in case of any modification to the machine. Finally, some functions are considered critical and must be tested at the end of the intervention to show that they have not changed. This is the case, for example, for the tightness of a freeze dryer or a fluidized bed dryer, or the integrity of the door seal of an autoclave. The maintenance department must then write test procedures for these critical functions. These procedures must define all the parameters (frequency of testing, acceptance limits, etc.) required.
Document management is therefore at the heart of the concerns of pharmaceutical and chemical industrial laboratories. With the Mobility Work application, it is possible to add all types of documents (text, Pdf, Excel, images, photos, audios, etc.) to equipment or interventions, and to consult them at any time from the field thanks to the mobile application. This allows maintenance operators to access the technical documentation at the foot of the machine, and in turn to provide exhaustive information on their interventions. This makes it much easier to comply with the procedures imposed by GMP.
Free import of your data
Real-time reporting via the news feed
Audit trail
Document management
Checklists
SSO and SLA
Spare parts inventory management
Preventive maintenance management
Intervention planning
Dynamic analytics dashboards
Mobile version at no extra cost (iOS and Android)
Community of maintenance professionals from the pharmaceutical and chemical industries and many others
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