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PC-TOOLCRIB > FDA Compliance




Medical Device & Pharmaceutical Manufacturing
   US FDA 21 CFR Part 11 &  820

The US Food and Drug Administration in 1997 issued Title 21 of the Code of Federal Regulations (CFR) to establish regulations with guidelines to monitor medical device and pharmaceutical manufacturers to ensure security and quality are obtained in an electronic record keeping environment prevalent in today's industry.  Two articles of this CFR, 11 and 820, describe the requirements for secured electronic records guaranteed by trustworthy electronic signatures( 21 CFR 11), and a quality assurance guideline from design through service of human-consumed products(21 CFR 820). 

For FDA 21 CFR 11/820 compliance, the PCT-Gage (Serialized Assets) Module is a required addition to PC-TOOLCRIB to manage serial numbered gages, tools, test equipment, and parts .  To further extend the capabilities and compliance to other manufacturing equipment, the SY-CON EM Preventative Maintenance Management subsystem integrates with PC-TOOLCRIB for emergency and PM work order generation for complete asset management.



Part 11 - Electronic Record Keeping
This FDA regulation stipulates that all types of records both active and historical must be authenticated, printable and exportable, and must be secured, but readily accessible.  PC-TOOLCRIB fully complies with this requirement by:
Part 820 - Quality Assurance Measures
An entire section of this regulation describes the testing/calibration, measurement, and inspection of equipment.  PC-TOOLCRIB provides advanced features to track, return, inspect, and calibrate serial numbered equipment.
Access Limitations
Access to the software and critical information is limited by requiring a log-in ID and password.  Each log-in ID is further confined to accessing features it has been granted.  Only specific log-in ID's should be given permission to perform calibrations, modify procedures, and export history information, while others can be give permission to only view these types of data.

Audit Trail
All activities are recorded and each transactional record is marked with the ID of the employee who performed it.

Printable Information
Any activity performed can be readily reported including the log-in ID who performed it.

Exportable Records
Any data recorded in PC-TOOLCRIB can be easily exported to an ExcelŽ spreadsheet or other formats from individual tool and serial number records to detailed calibration history data.

Electronic Signatures
A critical requirement is verifiable electronic signatures for both the electronic recording keeping of Part 11 and for the quality control aspects of Part 820.  An employee number and PIN meets the FDA definition of an electronic signature. When a calibration is entered into PC-TOOLCRIB it requires the selection of a valid employee number and the entry of that employee's PIN before a calibration can be accepted.  Additionally changes made to procedures describing the steps and methods to test, calibrate, or repair a serial numbered tool must also be validated with an employee number and PIN.

Tracking Procedure Changes
When a procedure as described above is altered the change is recorded and a corresponding report can delineate each occurrence and the employee associated with the change.
Employee Certifications
PC-TOOLCRIB prevents designated tools and equipment  requiring a specific level of expertise from being given to an employee who does not meet the training level. Misuse and accidents are avoided.

A complete tracking history of each individual tool is retained by the software for life.  Record employee, batch, job, department, machine, or other charge center codes every time the tool is issued.  From the date the tool was added to the software to every time it was returned to the crib, each calibration date, and if warranted, the scrap date can be readily reported.  If there is a problem with the tool you will be able to easily locate every where it was used.

Calibration Labels
Each time a serial numbered tool is calibrated you are given the option to print a small label to be placed on the tool.  The label shows when it was last calibrated, when it is next due, and other pertinent information.

PC-TOOLCRIB can alert you automatically or on-demand with a recall report when gages/equipment are due for calibration or inspection today, tomorrow, this week, next week or next month based on  days out or next due date.

Calibration History
Calibration or inspection history for any serial numbered item is retained for an indefinite time period.  Full details concerning each calibration can be exported, viewed online, reported as an email or printed.

Mobile Calibrations
Perform complete calibrations wherever the gage or equipment is located using any 802.11a/b/g handheld PC.  Enter readings, place it "out-of-service", view procedures, and add comments all in real-time.