Best Practices: Implementing Computer System Validation

Why is Computer System Validation important for the Life Sciences industry? CSV prevents software malfunction, but more importantly, it’s the law! Arithmos explains why CSV is particularly important in the clinical trial sector.

As the pharmaceutical and life sciences industries continue to modernize and implement technology, there is an increasing need to be sure these technologies are safe and accurate for patients and end users. Computer System Validation (CSV) is a documented process for assuring that a computer system does what it is designed to do. Both the European Medicines Agency (EMA) and the Food & Drug Administration (FDA) have produced guidelines for CSV practices.

csv

There are two important reasons for performing CSV with life sciences technologies and software:

  • CSV can prevent software problems before reaching the usage environment. In particularly in the clinical trial field, malfunctioning computer systems can cause serious adverse consequences to the patient. This could lead to lawsuits, fines or eventual shutdown.
  • Not performing certain computer system validation in accordance with Best Practices could be against the law. Both the EMA and FDA have rules and regulations in effect for GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices) and GCP (Good Clinical Practices).

FDA

The FDA is aiming to strengthen its CSV standards by aligning them with international standards like ISO 9000:2000. GAMP (Good Automated Manufacturing Processes) focuses on applying GxP (Good Practice Quality Guidelines) to the IT environment. FDA regulations depend on the type of software being validated, off-the-shelf, configurable or customizable software, “retrospective” validation for older systems that have never been validated and business and compliance risks.

EMA

The EMA revised its CSV guidelines in January 2011 which were implemented in June 2011. Topics include requirements for spreadsheets, data security of databases, risk management, retrospective validation, storage time of electronic data and documents and validation for small devices. The EMA’s website, http://www.ema.europe.eu offers the latest CSV regulations and validation.

21 CFR Part 11 Compliance

21 CFR Part 11 compliance is required for electronic records and electronic signatures. CSV becomes important as the FDA requires all computerized systems with GxP electronic records to be validated. The life sciences industry is proactive in validating systems in compliance with 21 CFR Part 11 which means the ability to generate accurate and protected records and time-stamped audit trails.

Arithmos and Computer System Validation

Arithmos has extensive experience in the computer system validation of GCP applications, in particular Oracle OC/RDC and AERS. Arithmos can support customers in planning, conducting, reviewing and maintaining the validation status of their applications through GxP assessment, validation planning, user requirement analysis and authoring as well as IQ/OQ/PQ authoring and execution including validation reports. Arithmos can provide CSV training and support customers in developing internal SOPs for CSV. Arithmos has an ISO 9001 certification for its Quality Management System.

 

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