Effective Lab Digitalisation Requires Process Understanding.

Reengineering towards Quality, Integrity, and Compliance.

WEDNESDAY 16th OCTOBER 2024 - 13:30 to 17:30

Bob McDowell at PLA2024Europe

Presenter: Bob McDowall, director at R D McDowall Limited

Experienced Principal with a demonstrated history of working in the pharmaceutical and allied industries on computerised system validation ( CSV) , management consultancy , 21 CFR 11 and data integrity. Skilled in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Change Control, Computerised System Validation, and Laboratory Automation. Trained auditor. Writer of articles and books as well as white papers for clients. Published articles can be found here: www.rdmcdowall.com/library

Bob is an auditor and he has been involved with the validation of computerized systems for over 30 years and is the author of books on the Validation of Chromatography Data Systems (two editions 2005 and 2017) and this year published his book on Data Integrity and Data Governance - Practical Implementation in  Regulated Laboratories.

Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals.  He is also involved in the GAMP Data Integrity Special Interest Group and is a contributor and reviewer of the 2017 GAMP Guide for Records and Data Integrity and the Good Practice Guide on Data Integrity - Key Concepts.

Reference Last edition: Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories Royal Society of Chemistry 2019.

Objectives of this session 

When digitalising a laboratory, it is important to have an overall strategy for automating a laboratory as there is no single application that will accomplish the task.  There are LIMS, ELN, LES and instrument data systems and it is important that selected ones are positioned and prioritised in order of implementation.  One question arises is it best to implement top down (e.g. LIMS or ERP) or bottom up (CDS, instrument data system) first?  As a LIMS or ERP may take a long time, it is best to automate the analytical process first followed by a LIMS or ELN as business benefits can be obtained relatively quickly.  This session will focus on automating the analytical process.

However, there is no point implementing any computerised system without delivering substantial business benefits.  As a corollary, automating the current analytical process is bad idea as it is likely to be slow and inefficient and automation results in a slow, inefficient and expensive semi-automated process.

Process understanding is a critical but often overlooked component of laboratory automation and digitalisation.  It is unlikely that current business processes in a laboratory can be automated effectively if computerised systems are used in hybrid mode (signed paper printouts of electronic records), paper records are used and manual input to one or more spreadsheets.

The session will present a methodology that can be used to map a process in an analytical laboratory.  Then examples of existing or As-Is processes and gathering the associated information required for redesign will be shown and critiqued.

Redesign requires the following three principles to be applied:

  1. Data Capture at the Point of Origin
    Never write a record on paper - direct data entry into a computer system.
  2. Never Transcribe Data
    Once data are electronic – they remain electronic
    NEVER print; NEVER retype into another computer system.
  3. Know Where the Data Go
    Easy and quick retrieval at any time; this may require naming conventions for locations, data files etc.

Implicit in these principles is that quality, integrity & compliance with quality standards or regulations are designed into the process.  This is the responsibility of the laboratory and not quality assurance; the latter are responsible for oversight of the work.

The session will be divided into the following two parts:

  • Principles: presentation of why process is understanding is important, the IDEF methodology for process mapping and how it will be conducted.
  • Practice: Based on case study examples of current processes improvement ideas will be used to redesign and remove paper and spreadsheets to ensure process efficiency.

Attendees will be able to access three e-books written by Bob on laboratory digitalisation.

Who should benefit 

Departments: R&D, Lab Operations & Management, Manufacturing, Quality, Data Science, Digitalisation/IT
Roles: Head, Leader, Manager, Scientist