Time-saving Paperless CalibrationsWi-Fi or Off-line, Mobile Devices Provide the Complete Program Interface
All companies selling goods 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.
ProCalV5 Paperless Calibrations
In an environment where power, versatility and ease of use are just as important as maintaining a compliant system, Prime Technologies’ software solution, ProCalV5, 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.
Why paperless with ProCalV5?
With ProCalV5 you have the ability to export data from your production database to a Windows® enabled device. With copies of your production records on a mobile device, your technician can then enter calibration results as the calibrations are being performed in the field and on the road. 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.
Paperless Calibration Points of Interest
- ProCalV5 is validated, industry proven and an easy and economical system to deploy.
- It is used by major pharma companies around the globe as their preferred paperless calibration system (Merck, Astra Zeneca, Sanofi, etc.).
- Your existing asset record data can be automatically uploaded from Excel spreadsheets.
- Our clients boast of significant operational cost savings & no major or minor GMP audit findings.
- FDA compliance is ensured with locked-down workflows and validated, 21 CFR Part 11 compliant paperless functionality:
- Can be used with validated, off-line, 21 CFR Part 11 compliant tablets and laptops
- Master asset record calibration details are standardized & clearly understood
- E-signature approval features effectively manage initial document acceptance, electronic change control and QA acceptance of work performed
- All past/present/future activities are well documented and data is instantly retrievable at a single workstation for management review, GMP audits, etc.
- No human errors – the system does all math when creating asset records. Visual prompts to technicians verify in/out of tolerance acceptance conditions during data entry
- Instant reverse traceability reporting
- Automatic schedule reminders and notifications
- Automatic QA alerts and out of tolerance reporting
Paperless Case Study
If you’re looking to streamline your record-keeping and reporting practices, electronic records management systems can help. A recent calibration management initiative at Schering-Plough underscores the point. Click here to read the study on “Prepare to Go Paperless” as written by the Editor in Chief of Pharmaceutical Online.
The migration consisted of 32,000 tags, 10,000 instrument loops, 1000 motors, 1000 relief valves, 19 years of calibration history and a customized test equipment data base. We were quite concerned about the 19 years of history and insuring that it remained intact.
We perform calibrations, motor and relief valve pm’s daily, the ProCalV5 engineers provided methodology and tools to make database validation possible, a daunting task with 19 years of history, and helped develop a plan to minimize database down time when switching to the new ProCalV5 database. The ProCal team worked tirelessly to find ways to mimic the functionality that we had built into the customized Loveland database. We were on a strict time table and the ProCal deployment initiative met the milestones which allowed us to stay on schedule. Prime Technologies provided two levels of training, administrator and technician training. The project was a total success. We have had two major outside audits since implementation, the ProCal database and reporting tool greatly contributed to the successful audit. Prime Technologies was extremely supportive before we purchased, during the implementation and now two years after go live. They are very responsive to our requests.