Description

Workshop on Good Documentation Practices for Testing and Calibration Laboratories

Build a Robust Documentation System to Ensure Compliance, Traceability, and Data Integrity

 

In the highly regulated environment of testing and calibration laboratories, documentation is not just a procedural requirement — it is the backbone of quality, traceability, and credibility. The ability to create, control, and maintain accurate and reliable records is essential for demonstrating technical competence, ensuring data integrity, and satisfying accreditation requirements. This focused half-day workshop is your definitive guide to understanding and implementing Good Documentation Practices (GDP). By concentrating on the principles, procedures, and practical aspects of documentation management, you will gain the knowledge to establish a robust documentation system, avoid common pitfalls, and confidently prepare for internal and external audits.

 

Actionable takeaways for your Job Role

By the end of this workshop, you will be able to confidently:

  • Understand the Principles of Good Documentation Practices (GDP), including ALCOA and ALCOA+ principles for data integrity.
  • Apply the Documentation Requirements of ISO/IEC 17025:2017, covering document control, record retention, and traceability.
  • Create, Review, and Control Documents including policies, standard operating procedures (SOPs), work instructions, and forms.
  • Implement Effective Record-Keeping across all laboratory activities—from sample receipt and test methods to equipment calibration and reporting.
  • Identify and Avoid Common Documentation Errors and implement preventive measures to ensure compliance.
  • Manage Corrections, Amendments, and Archiving of laboratory records in accordance with standard requirements.
  • Prepare for Accreditation Assessments with clear, organized, and auditable documentation.

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence, in your job-role:

  • Review and update documentation to ensure alignment with GDP requirements and ISO/IEC 17025:2017.
  • Create clear, accurate, and compliant laboratory documents.
  • Maintain accurate and complete records for laboratory activities.
  • Implement effective document control processes.
  • Identify and correct documentation errors.
  • Ensure documentation readiness for internal audits.
  • Maintain documentation for external assessments.

 

Course Curriculum

The course is structured into focused modules, designed for optimal learning flow:

  • Module 1: Introduction to Good Documentation Practices: Principles, Importance, and Regulatory Requirements

  • Module 2: ALCOA and ALCOA+ Principles for Data Integrity: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

  • Module 3: Document Control as per ISO/IEC 17025:2017: Creation, Review, Approval, Distribution, and Version Control

  • Module 4: Laboratory Records Management: Sample Receipt, Test/Calibration Records, Equipment Logs, and Calibration Records

  • Module 5: Common Documentation Errors and Preventive Measures: Corrections, Amendments, and Archiving

 

Job Roles That Will Benefit

This workshop is essential for professionals involved in laboratory operations, quality assurance, and documentation management, including:

  • Laboratory Managers, Quality Managers, and Technical Managers

  • Quality Assurance and Quality Control Personnel in testing and calibration laboratories

  • Laboratory Technicians and Analysts responsible for maintaining records

  • Internal Auditors and Document Controllers

  • Accreditation Consultants and Professionals supporting laboratories

  • Regulatory and Compliance Personnel working with laboratory activities

  • Personnel responsible for maintaining laboratory accreditations

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a basic understanding of laboratory operations and quality management systems to maximize their learning from this workshop.

 

Course Features & Included Materials

  • Focused Content: Concentrated training specifically on Good Documentation Practices—covering ALCOA principles, document control, and record management.
  • Interactive Sessions: Engage in practical case studies and group discussions to tackle real-world documentation challenges.
  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced laboratory quality professionals.
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Evaluation.
  • Certificate of Participation: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Build Documentation Confidence in Your Laboratory!

Strong documentation is the foundation of a reliable and credible laboratory. Gain the knowledge and practical tools to implement Good Documentation Practices that ensure data integrity, traceability, and regulatory compliance. Prepare your laboratory for successful internal and external audits with a robust and organized documentation system.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376