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FDA's New Enforcement of 21 CFR Part 11
Strategies and Tools to implement FDA's New E-records&Signatures Directions



Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions



Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

January 14, 2010


Latest Compliance Update for Computer Systems

Learn from FDA and Industry Practioners and get Tools for Implementation


Risk Based  Computer Validation and Part 11 Compliance

With Strategies for  FDA/ISO Compliance and Tools for Implementation



Validation and Use of Excel Spreadsheets in Regulated Environments

Strategies for  FDA/ISO 17025 Compliance and Tools for Implementation



Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for implementation#Recorded


Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions



Requirement Management for Equipment and Computer Systems
Strategies for Development, Documentation and Updates or Requirement Specifications



IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime


February 28, 2008

Auditing Computer Systems for FDA and EU Compliance
For Validation and Part 11 Compliance in Pharmaceutical and Device Industries

February 28, 2008

Validation of Existing/Legacy Computer Systems
FDA/EU requirements and strategies and tools for implementation



Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5



Master Planning for Software and Computer Validation
With examples for master and several project plans



Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance



Understanding and Implementing the New EU Annex 11
Learn about specific requirements and get tools for implementation



Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions


FDA's New Guidance on using Computers for Clinical Trials
FDA's New Approach Towards Computer Systems


Retirement of Computer Systems (170)
Strategies for FDA Compliance and Tools for Implementation


With compliance master plan, checklists, examples, audio seminar and SOPs for easy implementation

Click here for more info

Software Validation at the Vendor not Enough

483 Observation

The FDA inspection of a human tissue bank ended with with two observations. One of the them was related to software validation. It simply stated: The performance of computer software has not been verified. Specifically, your firm has not verified the computer software program being used of their donor referral operation to ensure that the electronic records are trustworthy, accurate and reliable.

Establishment Inspection Report

More information on what was wrong was included in the Establishment Inspection Report from the same inspection. It listed the same observation but a section on supporting Evidence and Relevance: The firm must verify the performance of the computer software for the intended use and document these activities.

Further details were documented in the section: Discussion with Management. The inspector wrote down questions and answers provided by the company

According to the report, the firm used a computer software program that is manufactured by (supplier) and has collected donors. The report continues: During he inspection, I (the inspector) asked the manager of clinical operations if the computer software has been validated to assure that it performs for its intended use. The manager told me that the software was validated by the manufacturer. The manager provided me a copy of a letter they received from the manufacturer indicating that the software was validated. The manager also gave me a copy of validation information that was obtained from the manufacturer during the inspection

I told the manager that I still needed to see what they have done to validate the system since the computer was making a decision to accept or reject potential donors. The manager of clinical operations and the manager of the communications center told me that they were unaware that the company had to validate the software because it was validated by the manufacturer and that was the reason for purchasing this software.

The Company's Response

In the meantime, the company has sent a letter to the FDA with a response to the observation:
"Immediately following the inspection, the company began the verification process of the software. The verification process is complete with the supporting documentation available for review."

How to get the 483, EIR and Company Response

The 483, the EIR and the company response can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down and to W-226 for the 483  to W-191 for the EIR and the company response

Recommendation from Labcompliance

Labcompliance recommends to share validation tasks between the manufacturer and user

The manufacturer should

  • Provide a list of functional specifications
  • Develop the software in a quality assurance environment
  • Develop the software according to documented procedures
  • Test each function of the software
  • Allow the user to review the development processes, test procedures and test protocols
  • Provide the user with a document stating that the software has been developed  and tested according to the company procedure (optional)
  • Provide services for installation, installation qualification and operator training
  • Provide services for verification of key functions in the user's environment (optional)

The user should

  • Develop user requirement specifications, that for commercial off-the-shelf (COTS) systems typically is a subset of the complete set of functional specifications
  • Conduct a manufacturer assessment  to check conformance with requirements as specified above
  • Installs the software and documents installation
  • Verifies performance for intended use. This includes testing of functions that are critical and/or can be impacted by the environment. It also includes all configuration settings made for the software specifically for the use. It also includes user specific test data.
  • Develop a maintenance and ongoing test program to ensure ongoing performance
  • Develop and implement a change control and revalidation procedure to ensure that the software maintains it's validation state after changes
  • Write a validation report and archive the report and all supporting documents.

More information

  • Get step-by-step advice on software and computer system validation and receive 10+ Best Practices documents for easy implementation in the Labcompliance audio Seminar Computer System validation: Step-by-Step.

Other Examples of FDA Warning Letters / 483's Related to Computer System Validation

  • FDA Inspectors also found many other deviations related to computer validation. To see examples, click here.

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