Companies selling goods in the US that are subject to the Food, Drug & Cosmetic Act (such as prescription drugs, over-the-counter drugs, biologics, medical devices, diagnostics, etc.) are required to keep certain records. Many of these records require a signature, documenting who did what and when.
Electronic Records Compliance
A company that maintains its records or signatures electronically (like most companies!) must also comply with 21 CFR Part 11 – FDA’s 2003 Electronic Records and Electronic Signatures regulation. Part 11 was not heavily or consistently enforced. New top management, and the new administration is widely expected to beef up FDA authority and insist on enforcement of existing regulations.
So, in an environment where power, versatility and ease of use are just as important as maintaining a compliant system, Prime Technologies’ software solution ProCal allows you to take advantage of the latest portable work-saving devices for real-time paperless field calibrations while still adhering to the quality and compliance requirements set forth by the FDA.
With ProCalV5 you have the ability to export data from your production database to a laptop. With copies of your production records on a mobile workstation, your technician can then enter calibration results as the calibrations are being performed in the field. Once completed, the calibrations may then be imported back into the production database achieving a smooth and paperless transfer of data and documentation of completed work.
Of course for any paperless system to be compliant with the FDA’s 21 CFR Part 11 rulings, the security settings established on the production database must also be in force on any mobile workstation. With this in mind, ProCal maintains all 21 CFR Part 11 compliance settings established on its production database when its records are exported to and then used in a mobile environment. This includes the recording of the system’s audit trail, requiring a reason for modification during record saves and approvals, in addition to continual password verification when adding, modifying and/or approving and finalizing the data collected.
Furthermore, the level of system access granted to users of the system on the production database carries down to the mobile workstation as well. All of these factors work to insure a secure, accurate and seamless paperless system.
ProCal Mobile Workstations Flow for Paperless Calibrations
Performance and Productivity with Paperless Calibrations & ProCalV5 include:
- 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 of an 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 (Corrective and preventive action) 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