Data Integrity Experts

A Division of PharmEng Technology

our experience has allowed us to develop the following tools for tackling all types of data integrity issues: 

  • Draft Protocols and Reports are in place for quick and efficient remediation

  • Prerequisite checklists for: general areas, personnel, equipment, and analytical methods

  • Outlines for testing procedures in monitoring, reviewing, and verifying 

  • Distinct and detailed frameworks to uncover the cause of every possible infraction

  • Remediation plans to provide and implement solutions to data integrity gaps


  AN OVERVIEW OF OUR IN-DEPTH AND   COMPREHENSIVE ANALYSIS OF DATA INTEGRITY ISSUES

AN OVERVIEW OF OUR IN-DEPTH AND COMPREHENSIVE ANALYSIS OF DATA INTEGRITY ISSUES


Lab documents and procedures

Review standard operating procedures

Review analytical data involved in data integrity

Examine instrument outputs, such as chromotograms and integrity of data

Review all records for accuracy and authenticity


Laboratory Investigation

Review the historical data

Initiate Phase I investigation as needed

Organize the retest plan of Phase II investigation in accordance with the existing SOP’s


Review general SOPs

Evaluate laboratory test procedure SOPs

Review SOPs for specific procedures

Review SOPs regarding laboratory data and results

STANDArd operating procedures 


METHOD VALIDATION AND METHOD TRANSFER

Review SOPs

Review method validation

Review method transfer

Examine reports and collaborative study results for method transfer


Laboratory Management Administrative System and Facility

Assess QC structure and responsibilities,

Review SOPs

Review glassware washing/drying procedures

Evaluate validation and training


Laboratory Computer System

Check compliance with CFR 21 part 11

Review validation of computer system, LIMS

Examine data archiving and retrieving

Review access, roles, and responsibilities


Laboratory Equipment

Calibration and maintenance documents and certifications

Installation, operational and performance qualifications (IQ,OQ PQ)


CLIENT TESTIMONIALS

 

"Thank you PharmEng, we really appreciate the hard work and sacrifices that your team made over the last few days at [client confidential] to review all data set over the weekend!”

- Director, Analytical Research & Development

 

Thank you again for your support. We’ll be sure to call PharmEng again for our next endeavor.”