Action Audit
Pharmaceutical Audit Software – GMP, FDA, EMA

Pharmaceutical Audit Software – GMP, FDA, EMA

With Action Audit, faster, smarter, and more compliant

Is your pharmaceutical facility truly inspection-ready?

are you inspection ready?
Every day in the pharmaceutical sector involves critical decisions that directly affect patient safety and product quality. Does your cleanroom, laboratory, or production line operate in full compliance with GMP, FDA, or EMA requirements? These international frameworks share the same objective: safe medicines, reliable production, and regulatory trust. The real differentiator, however, is not the documentation itself but the way it is applied and monitored on the shop floor.
are you inspection ready?

Cornerstones of quality in pharmaceuticals:

GMP (Good Manufacturing Practice)

- A worldwide benchmark ensuring medicines are consistently produced and controlled to quality standards. Adopted by FDA (21 CFR Parts 210/211), EMA, and WHO.

FDA 21 CFR Part 11

- Defines requirements for electronic records and signatures, ensuring data integrity in digital environments.

EU GMP Annex 1

- Specialized guideline for sterile manufacturing, focusing on contamination control and aseptic techniques.

ICH Q7

- Harmonized international GMP standard for API production, covering raw materials, equipment, and documentation practices.

ISO 14971

- Structured process for risk management of medical devices and drug–device products such as auto-injectors or inhalers.

ISO 17025

- Ensures laboratories operate competently and generate reliable QC and analytical testing results.

ISO 15378

- Defines GMP requirements for manufacturers of primary packaging materials such as vials, ampoules, and bottles.

Daily discipline – where compliance becomes reality

Cleanroom Compliance
Pharmaceutical standards only protect end-users if they are actively practiced every day. Small oversights in cleanliness, labeling, or documentation can quickly escalate into major compliance risks. Ask yourself:

  • Are cleanroom environments maintained -

    within ISO-class limits, with airlocks and gowning procedures followed precisely?

  • Is every container, reagent, and material -

    clearly identified and stored in the correct location?

  • Are balances, HPLCs, and other instruments -

    calibrated on time and properly documented?

  • Are deviations, CAPAs, and OOS investigations -

    logged and closed without delay?

  • Are chemical reagents and samples -

    handled and disposed of according to safety standards?
Cleanroom Compliance
Even the smallest compliance gaps can trigger regulatory findings – or worse, impact patient safety.

Internal audits as a driver of improvement

Regulatory inspections aren’t the only reason for audits. When carried out correctly, GMP and FDA audits help optimize processes, reduce risks, and uncover opportunities for efficiency. Regular audits enable:

  • Fewer compliance findings -

    Early detection of gaps before inspectors arrive.

  • Higher productivity -

    Better organization of workflows and material flows.

  • Robust documentation -

    Faster, more reliable responses during inspections.

  • Engaged workforce -

    Employees see procedures as tools, not obstacles.
Pharmaceutical companies that systematize internal audits report measurable gains in efficiency and readiness.

Staying ahead of regulators

Leaders in the pharmaceutical industry don’t wait for inspectors to knock. They build a culture of proactive monitoring and continuous improvement. Benefits of regular internal audits include:Spotting risks before they escalate Strengthening approvals and GMP certifications Maintaining full visibility of processes and risk levels

Action Audit – built for pharmaceutical compliance

mobile audit
Our software is tailored to the strict demands of pharmaceutical operations and the complexity of GMP and FDA standards. How it transforms audits: On-the-spot inspections Perform checks directly in cleanrooms, labs, or warehouses – no paper needed. Immediate escalation Non-compliances trigger instant alerts to responsible teams. Predefined pharma checklists Covering cleanrooms, laboratories, calibration, storage, and more – fully customizable. Centralized records Photos, signatures, CAPA logs, and full history accessible anytime. Automation at scale From CAPA reminders to calibration scheduling and deviation reporting.
mobile audit

Beyond the audit – turning findings into improvements

CAPA Management
The value of an audit is measured by what happens afterward. Action Audit ensures findings turn into effective and timely corrective actions: Automated CAPA plans Responsibilities, deadlines, and priorities defined instantly. Clear accountability Digital workflows keep everyone aligned. Live progress tracking Visibility of what’s resolved, pending, or overdue. Root cause elimination Analytics reveal recurring issues and prevent repeats.
CAPA Management

Proven results in the pharma sector

Up to 60% faster CAPA closure

- Reduced delays through automation and accountability.

95% on-time corrective actions

- Ensuring regulatory compliance readiness.

Higher inspection readiness

- Lower compliance risk and improved audit outcomes.

With Action Audit, your pharma team works:

Faster

- Real-time audits instead of weeks of forms.

Smarter

- Efforts focused on the highest-risk areas.

More reliably

- GMP compliance embedded into daily practice, not just binders.

How to run Action Audit in 3 steps?

Step 1

Click the link below and fill out a short form with basic details about audits in your company.

Step 2

Our specialist will contact you to arrange an online meeting and show how Action Audit works in pharma.

Step 3

Based on your input, we’ll configure Action Audit for you and provide a free trial for 30, 45, or even 60 days!

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