Covid-19 has brought the need for tomorrow’s way of working crashing down on us today. This “new normal” means that many people will be working remote as frequently as possible. This presents challenges, including how to conduct an audit. Fortunately, there is one solution available today to solve this “new normal” problem when it comes to remote cleanroom data, remote working, and remote audits: Particle Measuring Systems’ PharmaIntegrity data management solution allows you to access and share paperless data, reports (including trending) securely from remote locations in a 21 CFR 11 compliant environment with the auditor. Signatures are electronic so data is quickly and easily available. This keeps your team safe and meets regulatory needs while allowing for an effective and efficient audit. Improved processes = fewer errors, safer employees, efficient audits, and products released to market quickly. PharmaIntegrity eases the process for all involved. Learn more about PharmaIntegrity and contact us to get started.
Note that audits will mostly have to still be done face to face. But simple document approval, revision, and non-critic change approval could be performed remotely and smartly. A full audit may include a visit to your facility and production area, and, in that case, nothing may replace the physical presence of an inspector at the customer site
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
- 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
- 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.
Relevant 21CFR Part 11 Data Integrity Materials
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.