Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices (GCP)
  • All the Predicate Rules

Reasons for which Computer Systems need to be validated

The most important rationale for CSV, apart from its being required for the above stated, is that it is a very effective step towards ensuring the consistency of data and the quality of the product. This aside, CSV also helps in the protection of intellectual property (IP) by being a source that supplies data that is scientifically valid.

The 21 CFR Part 11 standard


The 21 CFR Part 11 standards, sometimes referred to as just Part 11, apply to the life sciences industry and consist of the criteria that the US FDA sets out for electronic records, electronic signatures and handwritten signatures. Its main purpose is to ensure that electronic records have the same equivalence as paper records as well as handwritten signatures.


Problems with Part 11 implementation

In the life sciences industry, the major challenges relating to adherence to Part 11 can be summarized as below:

  • Ensuring the accuracy of data and the security of information
  • Containing or preventing the loss of revenue from this exercise as well as to its business
  • Properly and sufficiently assessing gaps in the systems.

The costs of not getting Part 11 right can be high for companies:

They can have their New Drug Application (NDA) denied; they can experience a potential delay in their manufacturing actives, or can invite any of these:

  • Warning Letters
  • 483
  • Civil penalties
  • Possible prosecution if the investigation shows up negligence on their part


What are the steps for carrying out an effective Computer Systems Validation?


The validation process for 21 CFR Part 11 compliance consists of these core elements:

  • Comprehending the regulatory requirements
  • Taking steps for ensuring compliance with CSV requirements in a cost-effective manner
  • Carrying out testing of software and computer systems – initial and ongoing
  • Ensuring that the bare minimum documentation that FDA inspectors will ask for are available
  • Qualifying the IT systems network infrastructure and validating the network systems



Activities involved in Computer Systems Validation

Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences.

These can range from:


More than anything else, implementation of CSV is also important because it ensures that the data is accurate and the information, secure. Implementing Computer Systems Validation is also an important step in making sure that the organization restricts or prevents any loss of revenue from its main activities or from the CSV exercise itself. It also helps to thoroughly identify and close any gaps in the computer systems.

Getting CSV is very important

With all these uses of a CSV; it is imperative for life sciences organizations to understand how they can implement a CSV that is effective and compliant with domestic and international regulations. The CSV should ensure that the organization gets the most out of it while meeting regulatory requirements.



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The extreme importance of Quality Assurance for Computer Systems Validation (CSV)

Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11.

Knowledge gap

Many companies have a difficulty in determining what needs to be done, to meet domestic and/or international regulations or business continuity requirements, as a result of which Quality Assurance for Computer Systems Validation becomes incomplete. On top of these, as if these issues were not enough, the FDA has escalated 21 CFR 11 inspections that include CSV, making the already difficult task of requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11 all the more complex. Something like a fifth of all incorrect Medical Device Recalls is attributed to unfulfilled Computer Systems Validation, meaning that Quality Assurance is a big casualty.

Bleak future

What does a prognosis of this scenario look like? If anything, the number of recalls and Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) due to the product’s inability to meet Quality Assurance for Computer Systems Validation is set to go up. The reason behind this outlook is that technology is advancing, which brings with it many attendant pitfalls. And, as companies consider Cloud Technologies; there are sure to be patient privacy issues such as HIPAA involved in all this.

Roll up your sleeves; get your CSV right!

The costs associated with lack of implementation of Quality Assurance for Computer Systems Validation is quite shocking. In 2013, a single incorrect implementation of Quality Assurance for Computer Systems Validation resulted in fines of up to $three billion. It is but natural that software projects that need CSV get overrun by long periods of time. Corrections required to be implemented into a system that has been issued a 483 due to Quality Assurance for Computer Systems Validation can cost a quarter of a million dollars. Imagine the sheer amount of money needed when multiple issues are found.

Yet another critical reason, for which Quality Assurance for Computer Systems Validation has to be met, come what may, is that CSV is a foundation to other discovery, development & commercialization of products. So, not meeting Quality Assurance for Computer Systems Validation can result in a spiral: all the concomitant and ensuing efforts go waste.

All of this means that the need to meet Quality Assurance for Computer Systems Validation could not be more urgent or important.