How to Reduce the Burden of Validation Documentation by Using Lean Documentation and Risk Assessment Best Practices

o Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity

Despite the criticality of Computer Systems Validation (CSV) and its related regulations on data integrity, such as 21 CFR and Annex 11; perhaps no company seems to be happy at the prospect of carrying out validation. Why is this so? It is because most companies that have reservations about validating computer systems in accordance with 21 CFR and Annex 11 don’t realize its importance.


Many organizations and regulatory professionals show resistance to CSV because they believe that this is a time-consuming and expensive exercise. Many believe that implementing CSV retards the deployment of many features and functions that could accelerate the organization’s business growth. Nothing is farther to the truth than this.

Patchwork solutions

It is a misconception that solutions such as commercial off-the-shelf (COTS) systems solve the issues relating to cost and productivity. COTS is at best an ad-hoc solution that is bought and installed on servers internally and then configured to suit the company’s corporate network and with other systems and databases and then used to manage it according to the company’s IT strategy and its SOPs. So, what is wrong with this system?

CSV-processNothing, except that when a company opts for COTS, the COTS vendor supplies only the COTS software package, which still leaves everything other than it with the ownership, management and maintenance by the company. The company still incurs significant costs on critical areas such as maintenance, administering the internal network connections, securing the data, creating disaster recovery contingencies and keeping the required hardware viable, which is very capital-intensive.

Most companies don’t realize that it is this, and not proper CSV, which slows down business functionality. This arrangement, with its inherently slow pace of deployment and functionality, keeps burgeoning, even as the resources needed for its implementation keep becoming lean, becoming inadequate to meeting business needs.

And what about the humongous blunder of documentation? This adds greater burden and could require redoing the whole thing if something goes wrong somewhere. In addition, most vendors use current technologies such as the cloud. Here, the vendor is in partial to near-total control. The automation techniques the vendor would use to update features and functions could sometimes clash with the current validation processes.

The solution

The solution is to get clarity on how to meet the same level of Quality that complying with regulations and GAMP 5 ensures, while taking advantage of technologies such as cloud and SaaS implementations, and to keep abreast of the latest technologies while ensuring the quality of computer systems and that they are “built to regulations” to achieve Data Integrity.

All aspects of validation explained

At this hands-on seminar, Angela will describe how the participants can speed up validation that is current in keeping up with recent technologies while still implementing a rigorous computerized system compliance program. She will show how to use the methodology enhancers of risk management, lean documentation and automated testing for ensuring this. She will explain how companies can achieve rigorous compliance, build computerized systems to regulations and use techniques that reduce the validation effort.

Also splashed into this seminar is a set of exercises that includes a project which the attendees are currently working on. Angela will also bring in a Jeopardy style quiz to test the attendees’ knowledge, and to also ensure maximum retention of the concepts and practices.

As a result of the learning gained at this seminar, attendees will be able to:

  • Master the principles and regulations that achieve data integrity by applying the 21 CFR 11/Annex 11 and GAMP 5 validation of computerized systems regulations to computerized systems
  • Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity
  • Explain automated testing best practices how to select automated testing vendors to ensure that use of vendor tools allows for the flexibility to use Cloud/SaaS/IaaS/PaaS related technologies while maintaining data integrity
  • Explain how to use Hardware Qualification and Change Control to manage both internal network and infrastructure as well as vendors such as cloud providers.

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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.