Web Based Calibration Management System

Simple and Effective Solution for Equipment Calibration, PM
(Preventative Maintenance) and OOT(Out of Tolerance)
Management
GageFiles
Copyright@2016 Qualcy Systems Inc.

Problems With Manual Calibration Systems
• Paper based or Excel spreadsheets may be taking lot of your valuable time
scheduling, tracking and recording data for calibration and preventative
maintenance activities.
• Challenging to use the paper based specification templates to record the
calibration data.
• Calculation to generate the calibration certificate can take lot of time and prone
to error.
• Manual systems can lead to compliance issues, because sometimes people just
forget to complete the records, or simply misplace the records.

Challenges with Paper Based
Calibration Management
Systems
• Time consuming to create, store the records and retrieve the
records.
• You need additional space, manpower and money to manage the
manual paper records.
• It is almost impossible to run metrics on the paper based records.
• Always there is chance of missing the records or misplacing the
records.
• Higher chance of audit findings and compliance failure.

Challenges with Excel Based
Calibration Management Systems
• It is hard to control the access and changes when
multiple people have access to same excel file.
• It is confusing to track the revision and version of the
Excel files.
• You have to follow the nomenclatures of the files.
• You have to communicate the changes in the file
structure with the stake holders.
• The location of the Excel file can be easily changed. It
is hard to create any reminders in the Excel file.

ISO9001 : 2015 Requirement for Calibration Management
1. The organization will determine and provide resources necessary ensure reliable and valid
results when monitoring and measuring is used to release products and services.
2. The resources shall be suitable and maintained for continued successful release of the
products(fitness for the purpose).
3. The organization shall retain appropriate documented information for Calibration and
Preventative Maintenance Records (as evidence of fitness for purpose) of the
measurement devices.
1. The organization will determine which measuring and monitoring devices that are required for
providing assurance in the validity of the measurement results.
2. The measurement equipment will be calibrated using standards which are traceable to NIST or
international standards. When no such standards exist, the basis used for calibration will be kept
as documented information.
3. The measurement equipment will be identified and their status will be tracked.
4. The measurement equipment will be protected from damage or alterations that may impact the
calibration status of the equipment.
5. When the measurement equipment are found to be out of tolerance (unfit for its intended use)
the organization will determine if previous measurement results have been impacted. Based on
the investigation, the organization will take appropriate actions as needed.
7.1.5.1
7.1.5.2

FDA Requirement
• g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets
specified requirements and is appropriately designed, constructed, placed, and installed to facilitate
maintenance, adjustment, cleaning, and use.
• (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment,
cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met.
Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be
documented.
• (2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established
procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including
the date and individual(s) conducting the inspections, shall be documented.
• (3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are
visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel
performing these adjustments.
Sec. 820.70 Production and process controls.

Web Based Calibration Management Systems
• Gagefiles application from Qualcy Systems is a simple
web based software application hosted on the
Amazon EC2 cloud.
• It provides centralized data management
for calibration operations.
• All your data and records for the gages,
instruments and equipment are
available at one single location
• You can enter the calibration data in the
field or shop floor. No need to carry
the paper documents.
• You can route the calibration record
for approval with click of a button.

Organization of GageFiles CAL/PM Management System
Simple and Completely Integrated Solution
CAL/PM
Management
Integrated System
User Management
Register Users, Assign
Permissions
Equipment
Management
Register Equipment- Store
Master Data
Record Management
Create, Review and Store
Records

User Management Option
• In this option you can manage Users and their Role Permissions.
• When a new employee joins the company, you can easily register the user
and allow him the permissions necessary to get him started right away.
• When someone leaves the company, you can quickly deactivate their
permissions in one click.
• To help you easily migrate your existing user data, GageFiles has option for
adding any number of users in one click using an Excel upload template.

Option for Managing Master Data or Fixed Data
• The examples of master data include- Description, location, owner, date of
purchase.
• These data mostly do not change over the life cycle.
• You need to have master data of the equipment or gages in the system, so
that you can create records for them.
• To help you easily migrate the existing master data, the GageFiles provides
group addition option, you can upload any number of equipment or gages
with an Excel spreadsheet template.

Option for Creating and Managing All Your
Records
• For simple and easy navigation, the equipment master record is displayed
in a tree view.
• Once you open the master record, you can easily access and create the
calibration records and PM records with few clicks.
• With automated workflow option, the CAL or PM records can be
automatically routed to the approvers for review.
• The approvers get instantly notified. No need to carry around the paper
files. It saves valuable time and helps establish smooth work flow

Top 10 Benefits of GageFiles CAL & PM Solution
1: Create auto schedules and provide notifications for CAL, PM and OOT
You can auto-schedule both calibration and preventative maintenance, ensuring quality management of
your assets. By setting up approval requirements, records will be reviewed by the approvers automatically.

2: Use Auto Work Flow And Save Time
You can route the calibration and preventative maintenance and OOT records with click of a button. By
setting up approval requirements, records will be reviewed by the approvers automatically.

3: Use Flexible Calibration Templates
- You need calibration templates to record and maintain consistency in Calibration data. GageFiles provides
option to build flexible templates for the gages and instruments. Once created, those templates are available
over the life cycle of the instrument to help you maintain consistency of data.

4:Option for managing OOT (out of tolerance records)
When the calibration results fail, you can create out of tolerance records. The details of investigation
for product impact can be documented in the OOT record. You can set up the review and approval
of the OOT records as per your requirement. You can easily run metrics to see the trends for history
of equipment failures and take preventative actions as needed.

5: Built in Features To Comply With ISO and FDA Requirements
-Any changes made during the lifecycle of the records is automatically logged with time stamp. You
can easily access the audit trails and confirm the changes made by the users when needed. This is
one of the key requirements to comply with the 21 CFR Part11.

6: Option To Run Reports and Metrics
You can quickly run reports and see the trends for overdue calibration, PM or OOT
records. You can run reports by equipment, by owner, by location and many other
variables. You can use these reports for management review.

7: Quick Search Option
You can use the search menu option and find the records based on query selection. You
can search for the records by status, owner, approver, date created, and many other
variables. You can export the records to excel format also.

8: Printing of calibration Certificates and Labels
The calibration records and the PM records and OOT records can be printed in the .pdf format.
Also the calibration label can be printed from the system. You can print the .pdf reports of the
calibration certificates when needed. No need to store the paper documents.

9: Save Search Queries And Create Custom Menu Items
You can save any of your search query and give a name. This name can be made available
under the menu items. When you click on this menu item, it runs the same query. So this
option provides users to build custom menu items.

10: Provide Security And Back Up Of Your Data
-It is very critical that the best industry standard is followed to maintain the security and back
up of the data. You do not want to take any chances. GageFiles uses Amazon EC2 cloud servers
for individual customer data management. Each customer has their dedicated servers.
IT support or maintenance required.

Get Started with Your Simple and
Effective Calibration Management
System Today
Try GageFiles Today. 30 Days Free. Click Here
Qualcy Systems Inc.
5755 Oberlin Drive, Ste # 301
San Diego, CA 92121
Ph: 1-800-921-7505
Email: info@qualcy.com

Web Based Calibration Management System

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Web Based Calibration Management System