Avoiding the Risks and Costs of Poor IT Quality: Computer System Validation for Clinical Trials

Between 40-60% of software defects can be traced back to errors made during the requirements stage.

In anticipation of next month’s GIQAR conference in Verona, Italy, ARITHMOS discusses the risks and costs associated with poor IT quality in the clinical trial environment. Implementing best practices for Computer System Validation will help Sponsors comply with regulatory standards and avoid paying high costs for IT support and bug fixing down the road. 

scheiThe costs of IT quality can be an investment: from documented planning and prototyping to review and inspection and test execution. However, the costs associated with poor quality normally outweigh the costs associated with good quality.

Defect correction, including diagnosis and bug fixing, can produce enormous costs for companies. More importantly, external failure can cause huge losses for a company. Operational defects can lead to lost productivity and lost sales. On a more serious note, it can lead to a delay in new drug approval or even regulatory fines.

The FDA has taken the initiative to improve IT quality in both clinical practices and manufacturing. In just the past decade, several pharmaceutical cases have been brought to justice under the FDA’s strict policies:

  • Case 1: a pharma company was fined $297 million USD plus 18.5% of drug sales; the drug was discontinued and 2 manufacturing plants were closed
  • Case 2: a pharma company faced a $650 million USD financial penalty and the closure of its manufacturing site for failure to meet quality standards for diabetic medication

Computer System Validation (CSV) is one way to ensure IT quality and provide documentary evidence (such as plans, records and reports) to guarantee a system works as it should. CSV can prevent software problems before reaching the usage environment.

The FDA is aiming to strengthen its CSV standards by aligning them with international standards like ISO 9000:2000. 21 CFR Part 11 compliance is required for electronic records and electronic signatures. CSV is essential in this case because the FDA requires all computerized systems with GxP electronic records to be validated.

stock-footage-portrait-young-female-hospital-doctor-using-computer-to-input-data-on-clinical-trialsEU Annex 11 requires that all computerized systems used in GxP-regulated environments are compliant in order to ensure integrity of records and data. It applies to the European Union and all foreign manufacturers who are seeking EU market approval.


How can companies ensure IT quality?

Quality means that the systems and the services you deliver meet specifications and is achieved by providing the desired functionality with minimum defects. A quality product has the following attributes:

  • Usability: it does what you expect
  • Availability: it is ready when you want it
  • Reliability: it does not breakdown and has a long shelf life
  • Maintainability: if it does break, you can fix it; if requirements change, you can modify it
  • Trustworthy: you know the end result – always
  • Affordability: the value to the business outweighs the costs

ARITHMOS has extensive experience in validating systems in the healthcare sector. To ensure patient safety and full adherence to regulatory requirements, we validate regulated systems in a cost-effective, efficient and fully compliant manner. We provide full evidence of the validation exercise, and when requested, fix non-compliant areas. For inquires regarding our CSV consultancy services, send us an email at info@arithmostech.com.


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