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GMP Testing Laboratory · Allentown, PA | Build Your Audit Package

PLUMGXP • GMP MICROBIOLOGY & FACILITY SUPPORT

Microbiology should not be your bottleneck.

PlumGXP combines responsive microbiology testing, onsite support, facility and utility testing, investigations, and a more connected client experience — giving your team greater visibility from sample receipt through final report.

Routine Ongoing outsourced microbiology
Overflow Flexible capacity when sample volume increases
Backup Contingency support when internal capacity is unavailable
Onsite Sampling, qualification, validation and investigation support
START WITH YOUR PROBLEM

What do you need help with?

Choose the area that best matches what your team is facing. The information below changes to show how PlumGXP can support it.

PLUMGXP SUPPORT MODEL

Product Testing

Outsource routine or specialized microbiology while keeping a clear view of sample status, completion, and reporting.

WHY IT MATTERS

Add laboratory capacity without adding permanent infrastructure.

Start with the work

What needs to move forward?

Choose the closest starting point. PlumGXP connects the relevant services into a practical support path—whether you need one test, a qualification program, routine field support, or help understanding an unexpected result.

A SIMPLER LABORATORY RELATIONSHIP

From sample to answer.

PlumGXP is designed to make the work visible — not disappear behind a laboratory door.

01

Submit

Request testing, submit documentation, or coordinate onsite sampling.

02

Receive

Samples are accessioned and enter the controlled PlumGXP workflow.

03

Track

Follow status and anticipated completion through the client experience.

04

Review

Access reports, supporting records, and project documentation.

05

Understand

Connect with scientists when a result requires interpretation.

06

Trend

Use account-level information and historical data to identify patterns over time.

A laboratory you can actually see

A better client experience.

Outsourced testing should not mean losing visibility or access. PlumGXP combines useful technology with a genuinely connected scientific partnership—so your team can stay informed, reach the right person, and move decisions forward with less friction.

What this changes

The portal supports the relationship—it does not replace it. Your team gains a clearer view of the work while staying connected to the people who understand the science behind it.

Talk with our team →
YOUR DATA SHOULD WORK FOR YOU

More than individual reports.

A laboratory relationship should make it easier to understand your workload, turnaround, open actions, and historical activity.

ON-TIME TURNAROUND 0% Illustrative client KPI
SAMPLES COMPLETED 0 Illustrative client KPI
AVERAGE TURNAROUND 5.2 days Illustrative client KPI
OPEN ACTIONS 1 Illustrative client KPI
Example Monthly Sample Volume
Jul Aug Sep Oct Nov Dec
MORE THAN A TEST RESULT

When something goes wrong, the work should not end with the report.

Testing tells you what was recovered. Good science helps determine what it may mean.

1

What is it?

Identification can provide clues about likely source and environmental origin.

2

Where else?

Historical and facility trending can narrow an investigation and reveal recurrence.

3

How did it move?

Personnel, materials, utilities, cleaning practices and process flow all matter.

4

What next?

Laboratory data becomes more valuable when paired with scientific interpretation.

BUILT AROUND THE REALITIES OF 503B OPERATIONS

Outsource the testing. Keep control of the program.

You can outsource laboratory testing, but your Quality team still owns the oversight. PlumGXP is designed to make outsourced microbiology easier to see, easier to manage, and easier to understand.

A DIFFERENT CONTRACT LAB MODEL
A contract laboratory should reduce your workload — not become another vendor you have to chase.
PlumGXP is built to operate as an extension of your Quality and microbiology team.
01 VISIBILITY

Your sample disappears into a queue.

When testing is tied to release, qualification, or an investigation, simply knowing that a sample is “in the lab” is not enough.

See the Plum approach →
THE PLUM APPROACH

Make the work visible.

Track receipt, testing, review, anticipated completion, reports ready, and open actions.

Visibility without chasing the lab.
02 ACCESS

You need an answer, but cannot reach the scientist.

Technical questions should not travel through layers of customer service before reaching someone who understands the test.

See the Plum approach →
THE PLUM APPROACH

Direct scientific access.

Your project team can connect you directly with the people performing and interpreting the work.

Client → Project Team → Scientist
03 COMMUNICATION

You find out about a problem too late.

An unexpected result, delay, or investigation can affect production decisions long before the final report is issued.

See the Plum approach →
THE PLUM APPROACH

No surprises.

Proactive communication when timing, results, investigations, or project needs change.

Know what changed before it becomes a bigger problem.
04 INVESTIGATIONS

The report arrives, but the investigation has just begun.

An unexpected microbial result often creates more questions than the test report alone can answer.

See the Plum approach →
THE PLUM APPROACH

More than a test result.

Identification, trending, laboratory investigation support, historical context, and technical discussion with your Quality team.

Understand what the result may mean — not just what grew.
05 CONTINGENCY

You need backup capacity after something has already gone wrong.

Equipment downtime, staffing shortages, unexpected volume, and facility events rarely occur when it is convenient.

See the Plum approach →
THE PLUM APPROACH

Build contingency before you need it.

Use PlumGXP as routine, overflow, surge, or pre-qualified backup laboratory capacity.

A backup lab is most valuable before the emergency.
06 QUALIFICATION

Qualifying another laboratory becomes a project of its own.

Your Quality team needs enough information to understand, qualify, audit, and oversee the laboratory relationship.

See the Plum approach →
THE PLUM APPROACH

Make qualification easier.

Organized quality documentation, defined responsibilities, accessible project records, and a team prepared to support your qualification process.

Partnership should begin before the first sample arrives.
WHEN THE RESULT ISN'T ROUTINE

What happens next matters.

Unexpected Recovery → Microbial ID + investigation support
OOS / Atypical Result → Communication + laboratory investigation visibility
EM Excursion → ID + trending + scientific discussion
Internal Capacity Down → Qualified backup / overflow support
TRADITIONAL CONTRACT LAB EXPERIENCE
  • Sample disappears into a queue
  • Generic customer-service contact
  • Status requested manually
  • Problems communicated after the fact
  • Documents retrieved one request at a time
  • Vendor relationship
THE PLUMGXP MODEL
  • Visible testing status
  • Direct project and scientific access
  • Proactive updates
  • Early communication when something changes
  • Centralized documentation
  • Extension of your Quality team
A BETTER LABORATORY PARTNERSHIP

Testing is only part of the relationship.

Visibility, communication, responsiveness, scientific access, and support when something unexpected happens are what make outsourced microbiology work.

Confidence in Every Result. Talk to a Scientist →
TELL US WHAT IS HAPPENING

Start with the problem.

We have too many samples. → Overflow Testing
We are qualifying a facility. → EM + Water + Utility Qualification
We recovered an organism. → ID + Investigation Support
Our equipment is down. → Backup Laboratory Support
We need someone onsite. → Field Sampling / Qualification
We want to outsource microbiology. → Long-Term External Lab Model
QUALITY WITHOUT THE DISTANCE

Direct access matters.

PlumGXP

  • Client
  • Project team
  • Scientist / SME
  • Clear ownership
  • Visible testing status

Traditional large-lab experience

  • Client
  • Call center
  • Customer service
  • Project coordinator
  • Laboratory
Talk to a Scientist →