Valarie King-Bailey, CEOToday’s life sciences companies face unprecedented challenges from a market, risk, and compliance perspective. Global market forces demand that they do more with less. The complexities of business coupled with rapidly changing enterprise technology also demand a balance between risk and compliance to ensure success. Cloud computing today is widely seen as a disruptive force in the technology landscape. Although many companies are still deploying systems in an “on-premise” environment, many more are embracing cloud as a reality for the implementation of mission-critical enterprise GxP systems.
For over 40 years, validation processes have not changed much. “We see in our practice every day disjointed technologies, processes and manual paper-based procedures used to conduct validation. In today’s rapid pace environment, this is not only costly but perpetuates inefficiencies and waste across the validation process. We believe there is a better, smarter approach to computer systems validation that embraces the reality of cloud computing as well as on-premise and delivers an automated, holistic approach to governance, risk and compliance of validated computer systems,” explains Valarie King-Bailey, CEO, OnShore Technology Group. Lean validation, founded on the principles of lean manufacturing, are designed to eliminate waste in the validation process and drive more value-added activity designed to improve software quality and compliance.
Validation 360° is a best practices concept, not a product. It represents a smarter way to validate. “Based on the principles of lean validation, our Validation 360° approach is a well-rounded, holistic automation of best practices for computer systems validation to support good governance, risk and audit management, quality and compliance. This represents the vision of ValidationMaster™,” says Valarie.
“Every day, our mission is to help clients validate their enterprise systems in the most efficient, cost-effective manner.” Here’s how the concept of Validation 360° delivers on the promise of a 360-degree execution of validation projects.
Governance – To support good governance for validation, you must have a clearly defined set of Standard Operating Procedures as well as processes to support validation change control, corrective actions, incidents and non-conformances. Validation is all about documentation. If it’s not documented, it didn’t happen. To be effective, these processes must work seamlessly together and provide the tools needed to document and track processes throughout the validation lifecycle. “Our system, ValidationMaster™, delivers a seamlessly integrated solution that delivers quality and governance by design. It is tightly integrated with a document management portal to provide effortless process, testing, and quality documentation,” Valarie affirms.
Risk– A documented risk assessment is essential to determining how much validation due diligence is required. ValidationMaster™ includes proactive and reactive tools to identify, evaluate, treat and monitor risks throughout the validation lifecycle.
Every day, our mission is to help clients validate their enterprise systems in the most efficient, cost-effective manner
“Our Enterprise Risk Management module is universal and is compliant with any risk standard, such as FMEA, HACCP or ISO 9001”.
Quality – To drive efficiencies and promote lean validation, it is important to have a system that is quality by design. ValidationMaster™ is a next generation solution for integrated quality. During and after the validation process, change is a constant. The system includes built-in change control and other quality systems features such as CAPA, nonconformance and incident management. An effective system allows a single view of quality. ValidationMaster™ dashboards deliver real-time quality information to your desktop, phone or tablet device in an unprecedented manner.
Compliance – Regulations are a fact of life for life sciences. As companies endeavor to achieve a state of sustained compliance, they are asking more from vendors that supply solutions. The goal is to codify certain regulations such as 21 CFR Part 11 and cGMP to ensure that quality processes are delivered “out of the box”. “We built in functionality to support cGMP change control, audit management, CAPA, nonconformances, risk management and a host of other processes to help achieve level 5 compliance,” Valarie says.
Audit – Common in many validation exercises is the ability to track and manage audits for computer systems. Audits are typically conducted using paper-based processes and are sometimes inefficient and error-prone when it comes to tracking. “With ValidationMaster, our clients eliminate costly paper-based processes.” No more paper or spreadsheets are necessary, and they have the ability to plan and inform users with a shared audit calendar, reduce time to prepare audits with a central audit question library, reduce administration work and cost to generate audit check-lists and reports, save significant time preparing audit statistics, improve audit compliance through improved reporting, reduce the audit process through automatic workflow rules and to handle audit non-conformances CAPA while ensuring compliance with any standard or regulation.
We practice lean validation – “With a 360-degree view of validation we help clients address the WHOLE validation problem in context and not as a piecemeal effort. As our clients embrace the cloud as well as other enterprise systems, they cannot afford to be without the right tools that enable their success. As you can see with our tightly integrated system, we help clients save time and money by delivering a 21st century solution for validation that automates the process and helps them achieve compliance,” Valarie explains.