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What is Data Integrity & Why is it important?

eLearning information

Updated Friday, 5 July 2024 at 08:57

Reviews

Based on 238 participants

This course enables employees to quickly learn what Data Integrity is in a fun and interactive way.

Try a free demo

What’s included

  • Complete in 45–60 minutes, at your desk
  • Certificate on completion — keep for your audit trail
  • Full transcript and subtitles included
  • 365 days of access from purchase
  • Quiz-validated learning — proof you understood the material

Difficulty

Beginner level

Topics

GMP GDP EudraLex Volume IV Medicines Act Deviations Quality Assurance QC Calibration Validation Qualification CSV Quality Culture Manufacturing Distribution Aseptic

Learning goals

  • Explain what Data Integrity is and why it is so important,
  • Understand the expectations of ALCOA in Good Documentation Practices,
  • Establish a relationship between your own behavior and the expectations of Data Integrity.

Why take this eLearning

  • Built by the same PCS consultants who advise real pharma firms — not generic e-learning vendors
  • A certificate you can show your QP, QA manager or auditor
  • Straightforward GMP / GDP content — no fluff, no filler
  • Closes with a quiz so you can prove you understood the material

Description

Data Integrity is currently a hot topic worldwide. The issuance of warning letters by the US Food and Drug Administration (US FDA) has increased significantly and the trend continues.

Inspectors expect to see strong policies for handling data, both for written documents and digital systems. As a pharmaceutical employee, you must understand the principles of data integrity and know how best to record data.

ALCOA is recognized by national authorities as a tool to clarify expectations in good documentation practice, also known as GDocP. This course allows new employees to quickly learn how to complete documentation and make corrections using the ALCOA tool in a fun and interactive way.

Contents

  • What is Data Integrity?
    • Emergence of Data Integrity Problems
    • What is Data Integrity?
    • ALCOA
    • Digital Systems
    • Data types (including raw data)
  • What could go wrong?
    • Documentation
    • Analytical results
    • Electronic data
  • Relationship with corporate culture
    • What is Culture?
    • Three layers of culture
    • Cultural change
  • Summary, Exam & Certificate

Results

Participants who successfully complete this course will receive a certificate that they have successfully completed this course. The certificate is a digital certificate.

Frequently Asked Questions

How long do I have to complete the eLearning?

You have 365 days from purchase to complete the course. Work at your own pace — no fixed deadlines, no live sessions to attend.

Do I get a certificate upon completing the eLearning?

Yes. Once you pass the quiz you receive a PCS Academy training certificate for the GMP or GDP topic you covered — suitable for your HR file and audit trail.

In what language are the eLearnings available?

Most courses are available in Dutch and English with subtitles. Check the course detail for the specific languages offered.

What happens after I buy an eLearning?

You receive an email with a coupon and instructions to access the course on our learning platform. For invoice or bank transfer payments, the coupon is sent once payment is received.

I did not get an email with a coupon

First check that the payment has cleared. Coupons are issued manually on working days — if nothing arrives within a few hours, get in touch and we will sort it out.

What's in an eLearning

How the course is built

Every course is written by the same PCS consultants who advise pharma firms day-to-day. Theory is grounded in current GMP / GDP requirements and what actually works on the floor.

  • Interactive elements keep you engaged — no 60-minute talking heads.
  • Subtitles available on most courses.
  • Structured in short chapters you can pause and resume.
  • Full written transcript included for reference and audit purposes.
  • Jump back to any chapter at any time during your 365 days of access.

Learning platform

Courses are delivered through our Moodle-based platform at https://pcs-academy.site. Log in from any browser, on any device — your progress is saved between sessions.

If the platform is briefly unavailable for maintenance we will email you when it is back up.

Sharing and copyright

  • Reselling or redistributing these courses, modified or not, is not permitted.
  • Coupon codes are tied to the person or organisation on the invoice and cannot be shared.