In this article, you will learn what is Preventive Maintenance Management System (PMMS) according to the FDA requirements.
The cGMP allows implementing a PMMS either manually or electronically by your company.
Manual implementations are suitable for companies with a small number of equipment and resources to handle it.
Companies with many types of equipment and maintenance jobs involving many resources and personnel are good candidates to implement (electronic system) preventive maintenance software.
Preventive maintenance software is the main component of a computerized maintenance management system (CMMS). It supports companies maximize their resources, minimize operational downtime, extend equipment life spans, and reduce costs of maintaining their instruments and machinery.
The Preventive Maintenance Management System is structured and designed to handle the entire preventive maintenance operations.
It will manage the preventive maintenance requirements, activities, spare parts, and preventive maintenance records. Moreover, it organizes preventive maintenance works, schedules, preventive maintenance delivery, grading, and history.
A preventive maintenance management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of equipment preventive maintenance works. Some companies use dedicated software for this purpose, other companies handle their preventive maintenance management system manually.
The preventive maintenance management process includes managing and maintaining preventive maintenance records of the organization’s equipment and instruments. In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.
Silver Option. We Can Bring You Formal Training about what is Preventive Maintenance Management System (PMMS).
This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools. It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant. Request a quote now.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
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REFERENCES: WHAT IS PREVENTIVE MAINTENANCE MANAGEMENT SYSTEM (PMMS)
STATUTORY AND REGULATORY REQUIREMENTS –
TITLE 21–FOOD AND DRUGS
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Sec. 211.67 Equipment cleaning and maintenance.
TITLE 21–FOOD AND DRUGS
PART 820 Medical Devices
Subpart G–Production and Process Controls
Sec. 820.70(g) Production and process controls.
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