With ProCalV5, your organization can increase productivity and efficiencies in your operating procedures with our Paperless Calibration feature. Calibration and other Data that is collected in the field can be entered into ProCalV5 directly, with the option of this information then being viewed later for reporting purposes.
Since ProCalV5 is 21 CFR Part 11 compliant, electronic signatures are seamlessly done through the paperless environment enabling any organization with FDA requirements to efficiently comply by taking advantage of new technology. The ProCalV5 Mobile Workstation utility also allows any technician in the field the ability to use ProCalV5 on a portable lab top and do calibrations without the hassles of paper.
Performance and Productivity with Paperless Calibrations;
- A Paperless Calibration Solution Increases Technician Productivity in Excess of 100%
- A Documenting Field Calibrator Interface Supports the Latest in Technology for Maximum Efficiency
- Unlimited Ability to Expand Tests and Procedures for all Desired Validation & Calibration Activities
- Multiple Devices may be Placed Under Test Simultaneously and Individual Performance Easily Documented
- Calibration Requirements and Specifications may be Defined for Discrete Devices, Loops or System
Why Should My Organization Calibrate?
Throughout the world measurements are made daily in virtually every industry. The results of these measurements are used to make decisions that could ultimately affect people’s lives. In many industries, including the pharmaceutical and other life sciences, measurements are taken to ensure product integrity. The certification and calibration of instrumentation, combined with a robust calibration management system helps achieve product integrity throughout the production processes.
Good Engineering & Business Practice along with Regulatory Standards dictate routine Calibration. Such reasons include considerations for the fact that instrumentation will wear and settings drift, conditions that can have a negative impact on Performance & Quality instrument, as well as the fact that ultimately, calibration is required by FDA, ISO and other Regulatory Authorities.
Why Should My Organization Go Paperless?
The goal of any organization is to have its employees work efficiently as possible, while effectively running the entire business process. The fact of the matter is, paper based calibrations are costly, and do not increase effectiveness and efficiency.
Why Paper Calibrations are Costly include;
- Quality Managers will Spend over 35% of Their Time in Document Control
- Management Review Cycle Times are typically measured in weeks not hours and Critical Documents can be Misplaced
- A Bottleneck for Improvement - You can’t improve what you can’t measure, Quality Engineers Spend over 15% of their time Researching Performance Metrics
- With Paper Programs, Technician Productivity is typically only 3 to 6 Calibrations Per Day
- CAPA; - Paper Based Systems lack closed loop controls making it difficult to ensure corrective actions have been implemented
Normal Planned Maintenance helps assure resource availability and reliability, but calibration does more.
- Calibration is More Technically Rigorous
- Communication & Control of Acceptable Process or Device Specifications is Critical
- Subtle Performance Variations Directly Impact Product Quality
- Risk of Non-Compliance, Quality Excursions and Civil Liability is Higher than with Other PM Activities
- Although an Improvement, CMMS (Computerized Maintenance Management Software) Solutions are not Paperless for Calibration Activities
Highlights for Paperless Calibration via ProCalV5 include:
- Assign work electronically from portable devices
- Mobile Workstations display the full user interface with complete system functionality
- Automatically calculate signal correlations, test point tolerances, and check data entry tolerances.
- No need for written out calculations or calculator usage
- Calibrations can be completed quickly and accurately in ProCalV5 utilizing compliant electronic forms
- After work is completed, import completed work records back into the main database with complete data integrity checks
- Reminders, warnings, alerts, and approval routings can be automatically transmitted via email, LAN or WAN
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