Software validation is a fact of life for highly regulated companies that leverage advanced technology solutions to drive mission-critical regulated business processes. Validation and verification is essential to ensure that these systems meet their intended use and include the proper level of security to protect data and prevent unauthorized access and changes. An essential requirement for all validated systems is that they must be maintained in a validated state over time. This means that validation is a “living” process that requires change over time.
For years, life sciences companies have struggled with the documentation burden associated with software validation. Over the past two decades, there has been much discussion about “paperless” validation. However, the idea of paperless validation as well as other paperless processes has largely been an elusive goal that has plagued enterprise technology. During the early days of document management system deployment, a key driver of these systems was the promise of the “paperless” office environment. After millions of dollars spent on enterprise technology, paper lives on!
Life sciences companies today face mounting pressures to deliver systems with enhanced security, traceability and control to ensure sustained compliance. In addition to these concerns, today's life sciences companies must operate within an environmental, social and economic context where environmental sustainability is a key element of overall business operations. More and more, companies are independently seeking ways to become better stewards of natural resources taking into account the needs of future generations. The overall premise of the “green” economy is to reconfigure business processes and infrastructure to deliver better returns on investments, while at the same time reducing greenhouse gas emissions, extracting and using fewer natural resources, creating less waste. Given this imperative, any improvement in operational efficiency, cost and risk are compelling business drivers to replace inefficient, wasteful paper-based processes with secure, electronic ones. In support of green initiatives, I have been promoting the concept of “green validation”. The term “green validation” refers to a new, more responsible approach to software validation that leverages GAMP methodologies and advanced technologies to promote a paperless validation environment. Now, more than ever, is the time to awaken the vision of green validation and move this strategy from vision to reality.
THE PROBLEM WITH PAPER
There is an old adage in the life sciences community which says “… if its not documented, it didn't happen…” This could explain in part the love affair with paper. Paper is convenient. Most people still prefer to read printed documents in spite of all of the technology we have deployed. Paper is necessary to maintain an audit trail of paper records required by current global regulations. (I am often amused when organizations spend millions on content management systems with 21 CFR Part 11 signatures only to print the paper documents out and sign them by hand.) Yet, what many people don't realize is that paper is EXPENSIVE. Consider the fact that recent studies have repeatedly shown that in most corporate environments, knowledge workers spend up to 40 percent of their time trying to find paper documents. An excessive amount of time is spent searching for and retrieving documents costing billions of dollars of wasted time each year in the US alone. If you consider the fact that according to a recent study, the cost of paper is about .003 cents per sheet. Thus, if a typical life sciences company purchases 10 million sheets of paper annually, the total cost is approximately $30,000. 95% of this paper will have to be disposed of and most will end up in filing cabinets. When you add up the cost of photocopying, printing, faxing, mailing, storage, and disposal costs associated with paper, studies reveal that the costs can skyrocket to nearly $500,000 per year just to manage paper.
As you are aware, validation is very paper-intensive. All initial validation documents and their subsequent changes must be tracked and managed in a controlled manner. In addition, software validation documentation must be comprehensive to support the “intended use” principle. Given the broad range of systems on the market today, one of the main challenges associated with validation is applying a consistent methodology across multiple systems. For commercially-off-the-shelf (COTS) software, this is particularly important. Most COTS vendors offer “validation test scripts” with their solutions. Given the varying levels of understanding of validation among the COTS players, companies must deal with the inconsistencies of the COTS-developed test scripts.
Consider the statement in the guidance for software validation “... computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements…”
Also, 21 CFR Part §11.10(a) “…Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records…”
Beyond compliance, validation can offer significant business value and can be consider as somewhat of a “legal best practice” in providing traceability and accountability within business processes. FDA regulations are very clear in their expectations that organizations must adopt and follow very specific processes and procedures to ensure compliance. It is important to realize that regulations provide guidance and do not advocate the use of any specific technology to meet regulatory requirements. It is also important to understand that the U.S. FDA as well as other global regulations have embraced and even suggest the use of advanced technology to drive regulated business processes. It is a well established fact that many processes including validation are more effective if driven by technology. Paperless systems help to greatly facilitate compliance audits and help to reduce regulatory risk. From a validation perspective, it is time to move to the 21st century to promote “green validation”.
GREEN VALIDATION: PAPERLESS OR “LESS PAPER”?
Validation lends itself nicely to automation. However, when it comes to validation, there is a clear distinction between paperless validation and validation with less paper. Green validation does not necessarily mean “no paper”. Paper is here to stay. It is a reality and a fact of life. However, there are clear business and environmental imperatives for green validation. How is this achieved? The good news is that there are organizations developing validation toolkits and online electronic validation systems that allow you to track and manage requirements and validation protocols online to effectively produce validation document deliverables using an automated approach.
The concept of green validation includes integrated systems with built in validation best practices such as GAMP to drive validation efforts. Through the use of green validation software, you have the ability to apply validation principles and best practices to any validation project in a consistent, electronic manner. At the heart of the conceptual green validation system is a “requirements engine” that provides the ability to define validation user requirements and automate the tracaeability of the validation requirements to the validation test scripts. The automation of validation traceability will go a long way to save time and expense. Green validation software includes electronic workflows, electronic signatures, as well as requirements tracking and test protocol integration to help facilitate validation. Most importantly, green validation systems include integrated risk assessment to ensure that all validation efforts are conducted according to their defined risk.
With respect to validation project management, green validation systems should have the ability to allow validation project managers to track and manage multiple validation projects easily and provide “validation intelligence” or business intelligence dashboard functionality to allow project managers to quickly identify bottlenecks and address them to keep validation projects on time and within budget.
And finally, no green validation system would be complete without the ability to produce, manage, and track validation deliverables in a secure compliant manner. The system would include helpful reminders of key validation due dates and assess the impact of changes to help maintain the validated state.
TAKING VALIDATION TO THE NEXT LEVEL
Some may think why even consider the environment when discussing validation? As we all try to do more with less, it is about working smarter as well as efficient. Validation is a process that cries out for automation. Companies are spending excessively in terms of validating COTS software applications and creating reams of paper in the process. The same goes for custom solutions. In addressing these challenges of inefficiency and expense, it is prudent to also consider the impact on our environment because it is good business. Green validation systems take software validation to the next level. By leveraging advanced technology, companies can use less paper or paperless processes to produce validation documentation deliverables and maintain their systems in a validated state. Validation 2.0 is taking shape. The technology is here, and the time for green validation is NOW.