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Mainsaver 21 CFR Part 11
Compliance Module
In compliance with FDA Regulation 21 CFR Part 11 a requirement for your business? If so, Mainsaver gives you the secure, computer-generated, time-stamped audit trails you need to meet FDA requirements for all of your maintenance-related activities.
Mainsaver helps you implement the technical controls required by 21 CFR Part 11, from basic health and safety testing, to control and replacement of critical parts, to review and approval of work prior to commencement of production.
You can manage and audit maintenance compliance activities such as:
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Maintenance of assets, including those affected by preventive maintenance systems
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Asset service frequencies and service visits and corrective actions associated with such visits
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FDA regulations and requirements like those for lifting equipment, pressure systems, confined spaces, and asbestos protection
Mainsaver’s electronic signatures feature provides secure electronic sign-offs with an associated change log of all 21 CFR-related actions. This helps you ensure that all maintenance activities are suitably recorded for future inspection by regulatory authorities. You can select a variety of compliance-related events for tracking and auditing, including new, edited and deleted assets and/or work orders.
FDA Codes
With Mainsaver, any asset, activity or employee can be assigned a customer-defined “FDA code”. Authorized employees can add specific FDA codes to both new and existing assets, and FDA codes assigned to assets carry over to work orders and preventive maintenance assigned to the assets.
Authorized Electronic Signatures
Mainsaver ensures that only authorized employees can “sign off” on activities that require electronic signature (using a login ID and password). Date and time, authorizing employee and reason for the signoff are all stored with each electronic signature.
Tracking & Reporting
Using triggers created by the system administrator, Mainsaver automatically captures “before and after” images of any changed asset data. Any and all captured information can be reported, including related work orders and preventive maintenance events. Assets, work orders, preventive maintenance and employees can all be tracked and reported at any level of detail.
For example:
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Changes made to assets can be reported. Asset changes can be tracked by asset cost, location, status (new, edited, deleted and references)
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Work order changes can be tracked by status (new,deleted and references) and key attributes (including activity, labor, materials and contracts)
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Preventive Maintenance can be tracked by status (new, deleted and references) and related attributes (including work area and frequency code)
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Employees can be tracked by status (new and deleted) and specific crafts
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