Laboratory Data Integrity

Quintessence Enterprises Ltd and Dr Roberd McDowall of R D McDowall Limited, UK
Member of the ECA IT Compliance Interest Group, present the training Course Laboratory Data Integrity, as two-day HRDA training program of High Importance.

The course is being delivered online through the zoom platform οn November 16 & 17, 2020. The moodle platform is used for the asynchronous e-learning part of the program.

After the completion of the program the half-day visits to the participating companies will take place online a couple of days later, using the zoom platform.

Program code


Program numbering


Duration: 14 h


16 & 17 Νοεμβρίου 2020

Venue: Σύγχρονη

εξ αποστάσεως εκπαίδευση

Total Fee: €1600,00 + VAT

HRDA subsidy: €1.530,00

Net cost: €70,00

More than 3 participants: €600+VAT

Non HRDA beneficiaries cost: €900+VAT

The aim
this program

Why should you attend this program?

Identify the principles of data integrity, how laboratory data are generated, processed and reported and work with the data review and audit processes.

The training

Why did we design this program?

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records.
This definition applies to data recorded in electronic and paper formats or a hybrid of both.
To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in Good Manufacturing Practices of pharmaceutical products.
Data Integrity has become the major regulatory concern with Regulatory Agencies who have issued several guidances that focus on computerised systems, data governance and Data Integrity audits and investigations.
Data integrity and security infractions are a severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.

Who should attend?

Who Will you meet?

The course addresses the QC Analysts e.g. analytical chemists, pharmacists, regulatory personnel, pharmacopeia specialists.

More specifically, personnel involved in:

  • Managers and scientists from Quality Control and Analytical Development Laboratories wanting to understand the data integrity and audit process
  • Quality Assurance personnel providing data integrity and GMP oversight
  • Contract Research Organization and Contract Manufacturing Organization laboratory and QA personnel
  • Auditors (internal and external) responsible for assessing laboratory quality and data integrity

Course Facilitator

Who motivates you develop new knowledge?

Robert MacDowall

Pharmaceutical Consultant.


How you Will transform your cognitive profile?

Participants will be able to:


1. Identify the data integrity reuirements of a GMP regulated laboratory in Pharmaceutical organizations and contract labs

2. Ensure compliance with the EU and FDA Good Manufacturing Practice Regulations Impacting Laboratory Data and Results

3. Explain the ALCOA+ Principles

4. Utilize records generated by (1) Paper (records maintained in a laboratory notebook or controlled sheets), (2) Hybrid Systems (signed paper records with underlying electronic records) and (3) Electronic Systems incl. ELNs (an electronic system using electronic signatures)

5. Identify transcription errors when transforming data


1. Apply the ALCOA+ Principles to Laboratory Data

2. Audit the analytical records

3. Act in a “second person review” process to ensure that data issues are picked up and resolved in a thorough and effective manner

4. Handling transcription errors after transformation of data.

5. Collate and report results


1. Perform Self Inspections and Audits to Confirm Effective Data Integrity Controls

2. Prioritize the areas within a pharmaceutical quality system to focus when conducting a data integrity audit.

3. Defend the laboratory positions on data integrity policy and procedures


Which are the new cognitive subjects?

Day 1
How did we get here?
A Data Integrity Model
Principles of data integrity
EU and FDA GMP Regulations Impacting Laboratory Data and Results
Overview of DI guidance documents

  • MHRA and WHO Data Integrity Guidances
  • FDA and PIC/S data integrity guidance documents
  • APIC data integrity guidance document
  • GAMP and PDA data integrity guidance document
  • FDA inspection findings 483 and warning letters

Principles for the Generation of Data

  • A flexible analytical data life cycle
  • Static and dynamic laboratory data
  • Observational tests and instrument tests
  • Qualified analytical instruments and validated software
  • Integrity issues
  • Application of ALCOA+ principles

Generation of Data

  • What are the requirements for data integrity?
  • Three scenarios covering
  • a paper system
  • a hybrid system
  • a client server electronic system

Processing and Reporting of Data

  • Paper / hybrid based systems
  • Networked systems with electronic records and signatures
  • Calculations and transformation of data manually and by computer applications
  • Application of ALCOA+ principles to the process
  • Calculating the reportable value and comparison with the specification
  • Paper processes versus electronic processes
  • Linkage with out of specification investigations (OOS)

Day 2

Presentation: Understanding complete data and raw data (FDA & EU terms)


Processing and Reporting of Data

  • Reviewing an analytical record
  • Scenario covering paper based records and an electronic system

Reviewing Data

  • Role of the second person review
  • Determination that the reportable result is correct
  • Identification and correction of errors for paper and electronic systems . Audit trail review
  • Do you have complete data?

WORKSHOP III: Three Data Review Mini Workshops

  • Data Review of a Paper Record
  • Audit trail review
  • Spreadsheet printout
  • Chromatographic integration and data integrity violations
  • Ten Compliance Commandments

WORKSHOP IV: Facilitated Discussion
Paper, Hybrid and Electronic Reporting Processes
Discussion of the strengths and weaknesses of reporting processes

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