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.

Read More