Equipment Calibration Software Systems

Manage Equipment Calibration Schedules, Tasks and Data for FDA Inspections

Manufacturing and laboratory equipment such as instruments, apparatus, gauges and recording devices directly impact the quality and safety of finished product. Therefore, equipment calibration tasks are essential to a company’s quality management and regulatory compliance, with the U.S. Food and Drug Administration (FDA) mandating routine calibration of such equipment along with the retention of calibration records. MasterControl equipment calibration software helps automate and manage these calibration tasks to improve quality and compliance and minimize downtime.

Produktdatenblatt

MasterControl CAPA™

Produktvideos

Hunderte von Unternehmen weltweit nutzen MasterControl zur Automatisierung zentraler Unternehmensprozesse und Dokumentenmanagement-Aufgaben, um die Zusammenarbeit zu fördern, die Entscheidungsfindung zu verbessern und die Markteinführung zu beschleunigen.

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Demo: MasterControl Device History Record Management Software

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Demo: MasterControl Batch Record Management Software

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MasterControl Customer Testimonial by Wellington Foods on eBR

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Creating a Paperless Process Using MasterControl

Kostenlose Ressourcen

Wählen Sie alle Ressourcen aus, die Sie herunterladen möchten

Produktdatenblatt:

MasterControl Equipment Calibration™ MasterControl Equipment Maintenance™
Kostenlose Vorlagen:

Basic Policy SOP Template (Word Document)
Demo Video:

Übersicht über das MasterControl Qualitäts-Management-System (QMS)
Toolkit:

11 Free Resources to Boost Your FDA Readiness
Weißes Papier:

Calibration Software: The Buck Starts at User Requirements Automatisieren von Dokumentenlenkungsprozessen
E-Buch:

Compliance and Technology: How to meet changing FDA expectations
Fallstudie:

How Ash Stevens Inc. Boosted Its Equipment Calibration and Maintenance Compliance

Challenge	MasterControl Solution
Disconnected Processes Disparate equipment calibration systems lead to increased support costs, duplicate work due to overlapping functionality, and vital information that is inaccessible to quality processes, resulting in inefficiencies and quality issues.	Connected Processes MasterControl’s equipment calibration software is built on the MasterControl Platform, enabling companies of any size or industry to collect compliance-related data across departments and sites in a single repository for use in continuous quality improvement.
Lack of Control A well-functioning equipment calibration system depends on reliable task creation, routing and reminders. Even a moderately-sized program can have so much equipment requiring calibration that it can be challenging to maintain orderly records, avoid overdue tasks and experience delays.	Complete Control MasterControl manages the entire calibration schedule and automatically generates calibration tasks before they are due. The software maintains complete records and delivers advanced reporting capabilities to gain insights into calibration activities and equipment performance.
Poor Tracking Not only is it time-consuming to physically track paperwork in a manual system, but identifying and avoiding bottlenecks is almost impossible. Out-of-date calibration activities put you at risk of quality issues and unexpected downtime.	Automatic Tracking MasterControl automates collaboration, routing, follow-up, escalation and approval of important documentation, eliminating it as an obstacle to product release. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.

Challenge

MasterControl Solution

Disconnected Processes

Disparate equipment calibration systems lead to increased support costs, duplicate work due to overlapping functionality, and vital information that is inaccessible to quality processes, resulting in inefficiencies and quality issues.

Connected Processes

MasterControl’s equipment calibration software is built on the MasterControl Platform, enabling companies of any size or industry to collect compliance-related data across departments and sites in a single repository for use in continuous quality improvement.

Lack of Control

A well-functioning equipment calibration system depends on reliable task creation, routing and reminders. Even a moderately-sized program can have so much equipment requiring calibration that it can be challenging to maintain orderly records, avoid overdue tasks and experience delays.

Complete Control

MasterControl manages the entire calibration schedule and automatically generates calibration tasks before they are due. The software maintains complete records and delivers advanced reporting capabilities to gain insights into calibration activities and equipment performance.

Poor Tracking

Not only is it time-consuming to physically track paperwork in a manual system, but identifying and avoiding bottlenecks is almost impossible. Out-of-date calibration activities put you at risk of quality issues and unexpected downtime.

Automatic Tracking

MasterControl automates collaboration, routing, follow-up, escalation and approval of important documentation, eliminating it as an obstacle to product release. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.

Features of Equipment Calibration Software

MasterControl equipment calibration software is the ideal solution for managing calibration programs.

Calibration Scheduling The calibration schedule manages and automatically triggers all calibration tasks before they are due, dynamically routing tasks to the right person at the right time.
Activity Checklists Built-in disposition checklists guide workers to initiate further actions, such as failure investigations, requesting a repair or taking equipment offline if needed.
Automatic Escalation The entire calibration process, including task completion and review, is digital and automated, providing managerial oversight and enabling overdue tasks to be escalated to supervisors for resolution.
Analytics Reporting MasterControl Analytics can be configured to trend and analyze equipment calibration activities by parameters such as Calibration History, Current Calibration Tasks, Calibration Tasks Past Due, Failure Incidence by Equipment, Failure Incidence by Task, and Failure Incidence One Year Trend.
Configurable Limits and Instructions Specific instructions and limits, including measurement parameters, adjustment limits and failure limits, can be entered and automatically applied to the respective calibration step or activity.
Compliant System As with all MasterControl software, the equipment calibration solution is fully compliant with 21 CFR Part 11, providing time-stamped audit trails, reporting, and electronic signature capabilities. It also delivers security features that meet the latest industry requirements.
Complete Data Capture All user entries and calibration data, including As Found and As Left data, are digitally captured, stored and easily accessible for reporting and further action in the equipment calibration software.
Risk-Based Validation MasterControl’s Validation Excellence (Vx) methodology is a revolutionary approach that dramatically cuts the time, effort and cost of validation and makes it easier to validate software changes and upgrades.
External Collaboration Files from other systems and in different formats can be imported, such as third-party calibration certificates in lieu of in-house testing.

QMS-Anbieter für die FDA

MasterControl Inc. und sein Partnerunternehmen i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig und möchten nun auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.

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