Know what needs attention now.
Give center operations a clear view of product conditions, developing refrigeration concerns, and the next escalation.
- Simple facility status
- Prioritized exceptions
- Clear response ownership
Solutions
PlasmaAudit helps facility teams, quality leaders, and service personnel work from the same evidence without forcing everyone into the same technical view.
Built around the people doing the work
The point is not to show everyone everything. It is to show each person what helps them act.
Give center operations a clear view of product conditions, developing refrigeration concerns, and the next escalation.
Help leaders compare sites, review evidence, and focus attention where operating risk is developing.
Move beyond “the freezer is warm” with the signals and history needed for stronger triage and technician preparation.
FDA audit readiness
When FDA asks what happened, why it happened, and what you did about it, PlasmaAudit helps your team answer from one connected evidence trail instead of hunting through binders, inboxes, spreadsheets, and service tickets.
Sample statuses and percentages for illustration. This is not a live operational or calibration record.
The audit burden, handled upstream
PlasmaAudit turns daily monitoring into an organized record of what was measured, what changed, who responded, and how the issue was closed.
Pull the temperature history, operating context, alarm state, and response timeline together around the same event.
Evidence that tells the whole story.See when a condition moved, whether redundant probes agreed, when someone acknowledged it, and what happened next.
No unexplained red marks.Connect the monitored point to the probe identity, calibration status, service history, and the equipment it protects.
Traceability without the scavenger hunt.Review sites consistently, spot missing follow-through, and focus the quality conversation on risk instead of formatting.
Less searching. Better questions.From measurement to inspection answer
Instead of waiting for an audit to expose gaps, make the evidence trail part of the operating rhythm.
Continuous readings, alarms, and probe agreement.
Link conditions to equipment, location, calibration, and ownership.
See exceptions, acknowledgements, trends, and open actions.
Show the decision, the response, and the closeout evidence.
When FDA asks...
Your team should not need three people and two days to find the answer.
PlasmaAudit supports audit readiness and quality-system execution; it does not replace your validated procedures, QA review, or regulatory judgment.
Designed to fit the operation
PlasmaAudit connects center operations, quality leadership, and service response across an entire portfolio, with consistent evidence, role-based views, and site-specific workflows from the outset.
Planning a deployment
A practical starting point for operations, quality, and facilities teams.
Share your freezer and controller models, available sensor points, and site count. The team can then review integration fit and the proposed installation scope for your equipment.
Include operations, facilities or refrigeration service, and quality as appropriate. Bring your main operating question, equipment details, and your current alarm and response process. Leave patient details, credentials, and confidential records out of the inquiry form.
Confirm the site survey, installation access, any downtime, commissioning checks, training, and responsibility for each step when reviewing the proposal. The schedule depends on your equipment and agreed scope.
Ask the team to review your site's backup power, local history, buffering and backfill requirements, and how stale or missing readings will be identified. Confirm these arrangements for the proposed installation before relying on them.
The initial operating posture is monitoring, analysis, and recommendation. Your people remain responsible for equipment control, service, safety, quality, and operating decisions.
Bring your security questionnaire and data requirements to the conversation. Confirm access, ownership, retention, export needs, support responsibilities, and escalation contacts as part of the proposed service scope. The sales form is not an emergency-support channel.
Request a walkthrough with your site count and equipment context. Pricing and implementation scope are discussed for your facilities; submitting an inquiry does not book a meeting or commit you to a purchase.
Scale the operating picture
We will shape the walkthrough around the portfolio, quality, and service decisions that matter most.