Imagine a world where giving an getting approvals was easy for all to accomplish and equally easy to track and access. Such a world would work very well in the “new normal” when employees are frequently remote and unavailable for paper signatures. With Particle Measuring Systems’ PharmaIntegrity data management system you get a 21CFR11 compliant paperless environment with signatory ability to and from anywhere in the world.
Step up your “new normal” working environment and get started today. Learn more here and then contact us.
More about PharmaIntegrity
PharmaIntegrity, by Particle Measuring Systems (PMS), is the definitive solution for pharma to manage the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release, and reducing risks and costs associated with product loss and recalls. It brings the overall pharma environmental monitoring process into a modern, compliant, and easy-to-learn paperless data management solution.
PharmaIntegrity collects data from cleanroom monitors (PMS particle counters & microbial samplers, settle plates, TRH sensors, etc), manages all the data in a 21CFR11 paperless environment, and provides trending and other reports, available anywhere in the world, anytime.
Specific benefits include
Microbial Analysis
- Collect and store pictures of microbial identification
- Trend and report contamination flora by room, department, genus, species, strain, etc.
- View the distribution by room, department, etc.
- Correlate microbial test results with any other environmental data
PharmaIntegrity Mobile
- Easily navigate your digitized facility map
- Intuitively manage your workflow and ensure samples completion
- Label samples in real-time
Upload and manage data from particle sensors
In this time of a new remote work style, PharmaIntegrity by Particle Measuring Systems allows for remote approvals, reports, global inventory management, and more in a 21CFR11 compliant paperless environment.
Looking for a 21CFR Part 11 Solution for your cleanroom data. Look no further than PharmaIntegrity.
PharmaIntegrity Data Management System for Pharmaceutical Industry Data Integrity (21CFR11)
Relevant 21CFR Part 11 Data Integrity Materials
https://www.pmeasuring.com/blog/data-trending-annex-1-alert-levels/
https://www.pmeasuring.com/blog/new-normal-data-integrity-esignatures/
https://www.pmeasuring.com/blog/remote-audits-new-normal-21cfr11/
https://www.pmeasuring.com/blog/new-normal-particle-counter-data-remote-access-electronic-signatures/
https://www.pmeasuring.com/blog/electronic-data-in-pharmaceutical-manufacturing-microbial-monitoring/
https://www.pmeasuring.com/blog/data-integrity/
21 CFR Part 11 and Data Integrity Regulations Frequently Asked Questions
Complete Cleanroom Contamination Control Solutions
Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:
- Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial Monitors including portable/mobile, fixed/remote, and single use.
- Data management software from Particle Measuring Systems
Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.
