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Computer System Validation

INTRODUCTION

No matter what core services your company provides, if computer systems and software products are involved, efficiency will always remain one of your top priorities. This is not only due to the fact that efficiency ensures your customers receive the best service but also because inefficiencies and faults in computer systems can potentially result in catastrophic consequences. Therefore, ensuring your computer systems conform is crucial, and this is something that we can help with using Computer System Validation (CSV).

CSV is often used interchangeably with software validation and is conducted to prove that your software or systems are performing the way they are supposed to. This also ensures that they are not carrying out processes that prevent them from working. But what exactly does CSV entail? In line with the definition of CSV, software and systems must have:

  • Confirmation by examination: defined user needs and intended uses. You must also examine the software to ensure it is suitable to fulfil these requirements and carry out its intended use.
  • Provision of objective evidence: defined software requirements, with documentation of all validation activities and tests.
  • User needs and intended uses: building on ‘confirmation by examination’, you must also examine the systems to ensure they meet the needs of the previously defined user.
  • Particular requirements implemented through software: obtain confirmation that these requirements can be consistently fulfilled and define what needs to work to achieve this.
  • Consistently fulfilled: evidence is needed to prove all of the above, with documented validation required.

Validation models will primarily use the model below to assist with CSV and ensure that all the required evidence is obtained.

Now, let’s dive a little further into the importance of CSV.

IMPORTANCE OF CSV

CSV is important for a whole host of reasons but the three most commonly discussed focus on the reliability of systems.

  1. Providing accurate and consistent data.
  2. Creating transparent, traceable and tamper-proof electronic data trials.
  3. Safely and securely storing electronic data records that can remain intact for extended periods of time.


The best way to highlight the importance of CSV is with a devasting example. In the 1980s, the radiation therapy machine Therac-25 experienced programming issues. This prevented it from administering the correct amount of radiation to patients, and in many cases, a huge overdose was given. The resulting fallout was numerous serious injuries and deaths. In this case, no CSV processes were in place, and if they had been, this incident could have been identified and mitigated before patients were treated.

The Food and Drug Administration (FDA) provides comprehensive controls for that electronic records and electronic signatures under FDA 21 CFR 11 in the Code of Federal Regulations (CFR). A subsection of this mandate specifically applies to pharmaceutical and medical device manufacturers, biotechnology companies and any other FDA-regulated industries. To ensure compliance under this code, CSV is necessary.

FINAL REMARKS

Collectively, CSV is a crucial step for any company that relies on systems and software; however, it is also a legal and regulatory requirement and the process needs to be carried out. It is comprised of many stages and verification processes and ensures your systems remain compliant. In instances where CSV was not adhered to, risk is increased for catastrophic events to occur.

WHAT CAN WE DO FOR YOU?

RS NESS is a highly experienced service provider in both the Medical Device and Pharmaceutical Industries. Our services include computer system validation, ensuring that your systems remain legally compliant and successfully complete the tasks they are designed for.

We pride ourselves on our quality-oriented and hands-on approach. Our technical expertise ensures you receive the most effective and professional services, with our clients ranging from small start-ups to international corporate companies.

If you have any questions or need professional support, do not hesitate to get in touch with us.

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