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The chart below shows how a typical Life Sciences solution can be put together using AMMS. Each module is described in detail below. The core additional module here is the FDA 21 CFR Part 11 Compliance Package. This package includes a detailed Audit Trail of all changes to critical records, and enhanced security features such as electronic signatures and stringent requirements on passwords.

Equipment Management / Inventory & Purchasing These modules are the core of AMMS. Read more about these modules here.
User Customization The User Customization System (UCS) makes AMMS the most flexible CMMS / EAM solution on the market, allowing for customized data entry screens, reports, forms, data import/export interfaces and much more. Read more about UCS here.
FDA 21 CFR Part 11 Compliance Package (Audit Trail)

21 CFR Part 11 is a stringent final rule dealing with Electronic Records issued under the Department of Health and Human Services - Food and Drug Administration Code of Federal Regulations (CFR) - 21 CFR Part 11 dated March 20, 1997.

MicroWest has worked closely with large Pharmaceutical, Bio-Tech and Life Sciences companies to develop and implement a packaged set of features that makes AMMS easy to validate under these regulations.

MicroWest's package is viewed by many companies specializing in software validation as well ahead of its competitors. The package includes an internal, human-readable Audit Trail of all activities and changes related to critical components, procedures and security, and enhanced security features, such as intruder lockout, automatic logout after idle time, and scheduled password changes.

MicroWest does not perform validation services itself, but does offer a Validation Protocol Package to help accelerate the customer's validation process. Validation is performed by the customer, who may contract it to an outside Validation company. It is the customer's responsibility to validate the software and their process as defined by their own internal Standard Operating Procedures.

Calibration

The Calibration option allows for the testing of instruments and other devices using up to five different standards. It also allows for the storing of information and data associated with those tests for later reference and evaluation.

The Calibration option in combination with the User Customization option allows for the creation of user specific calibration forms and certificates, adjustment of calibration window headings which match user terminology, and adjustment of calibration data output to other programs for analysis.

Imaging Allows for attaching and printing images and documents such as scanned drawings, CAD drawings, MS Word documents, etc. to Work Orders, Equipments, Parts, Purchase Orders, etc.
Work Request Provides an interface for work requests which must be approved before becoming new Work Orders. For example, let a help desk attendant enter all call-in and walk-in requests as work requests. Then have a manager review them later and, if approved, make them into work orders at the touch of a button.
Web Request Web Request allows anyone to submit and get status on Work Requests via a web browser.
AMMS Mobile / Barcoding With AMMS Mobile, each employee carries a Windows Mobile or Palm PDA with them. They can create Work Orders on-the-fly, issue parts, check out tools, track assets, perform meter readings, and much more. At the end of their shift, they simply synchronize the PDA with AMMS to update the database. With the wireless version, they can update the database in real time, as well as look up information live from the AMMS database. With barcoding, you can create barcode labels for Equipment numbers, Part numbers, Room numbers, etc. which you can then scan to make data entry quick and precise.
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