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 SystemSimple 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 OOTYou 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 TimeYou 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 MetricsYou 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 OptionYou 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 LabelsThe 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 ItemsYou 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 92121Ph: 1-800-921-7505

Email: [email protected]


https://gagefiles.com/

web based calibration management system

Business