Unit 5: Computers in Preclinical Development

February 21, 2026

Semester 2
BP205T

Introduction to Computers in Preclinical Development

Unit 5 covers the specialized software used in pharmaceutical laboratories during preclinical drug development. These systems are mandatory for regulatory compliance (FDA, ICH guidelines) and ensure data integrity. Students pursuing a career in pharma R&D or Quality Control absolutely must understand CDS and LIMS.

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Syllabus & Topics

  • 1Computers in Preclinical Development: Role and importance.
  • 2Chromatographic Data Analysis (CDS): Purpose and components.
  • 3CDS Software examples: Empower (Waters), Chromeleon (Thermo Fisher).
  • 4CDS in HPLC, GC analysis: Data acquisition, peak integration, report generation.
  • 5Laboratory Information Management System (LIMS): Definition and purpose.
  • 6LIMS Functions: Sample tracking, test scheduling, result storage, compliance.
  • 7Text Information Management System (TIMS): Definition and purpose.
  • 8TIMS Applications: Literature management, regulatory document management.
  • 9Data Integrity in Pharmaceutical Laboratories: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
  • 1021 CFR Part 11 (FDA): Regulations on electronic records and electronic signatures.

Learning Objectives

Explain CDS: Describe the function of a CDS in an HPLC laboratory.
Understand LIMS: Explain why LIMS is essential for FDA compliance.
ALCOA+ Principles: Define each letter of ALCOA and explain why data integrity matters.
Compare Systems: Differentiate between CDS, LIMS, and TIMS in terms of their functions.
Regulatory Context: Explain what 21 CFR Part 11 requires for electronic records.

Frequently Asked Questions (FAQs)

Q1. What is a Chromatographic Data System (CDS)?

A Chromatographic Data System (CDS) is software that interfaces with chromatographic instruments such as HPLC and GC to acquire, process, analyze, and store raw analytical data. It generates compliant reports for quality control (QC) testing. Examples include Waters Empower and Thermo Chromeleon.

Q2. What is LIMS and why is it important?

A Laboratory Information Management System (LIMS) is software used to manage laboratory samples, test results, workflows, and instrument data. It ensures traceability, regulatory compliance with GLP (Good Laboratory Practice), and improves laboratory efficiency and data organization.

Q3. What are ALCOA+ Principles?

ALCOA+ defines the principles of data integrity:

  • Attributable – Identifies who collected the data

  • Legible – Readable and permanent

  • Contemporaneous – Recorded at the time of activity

  • Original – Raw data preserved

  • Accurate – Free from errors

  • + Complete, Consistent, Enduring, Available

Q4. What is 21 CFR Part 11?

21 CFR Part 11 is a regulation by the US FDA that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records in pharmaceutical and clinical research settings.

Q5. What is TIMS?

Text Information Management System (TIMS) is a system used in pharmaceutical organizations to manage large volumes of text-based information such as literature databases, SOPs, batch manufacturing records, and regulatory submission documents.