Cold Chain Monitoring for Cell and Gene Therapy
Monitoring, Compliance, and Protection—Simplified
Built Different. On Purpose.
Your ISO-classified cleanrooms are where your product gets made. If temperature, humidity, or differential pressure drifts out of spec, you have a batch problem and a documentation problem at the same time. PharmaWatch monitors all three continuously, alerts your team the moment something drifts, and logs everything automatically.
FDA wants to see where every biologic was stored, under what conditions, and who was accountable at every step. PharmaWatch logs all of it automatically — no manual entries, no gaps, no scrambling before an inspection.
All Compliance Documented Before They Ask.
Cell and gene therapy manufacturing carries some of the most demanding FDA documentation requirements in medicine. FDA 21 CFR Part 1271 and Current Good Tissue Practice (CGTP) require complete records of storage conditions, chain of custody, and corrective actions at every stage. FDA 21 CFR Part 11 governs how those records are created and stored electronically. One missing timestamp or unsigned acknowledgment can trigger a Form 483 observation.
PharmaWatch handles all of it in the background. Every parameter is logged continuously. Every alarm acknowledgment is timestamped and attributed to a user. When an inspector walks in, your QA team pulls a complete, ready-to-hand-over report in 3 clicks.
A 100% U.S. based support team that understands regulated manufacturing environments — available 24/7, every day of the year.
How PharmaWatch Protects Your Cell & Gene Therapy Facility
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