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It's time to Enable your Validation BPA

Business process automation (BPA) is the technology-enabled automation of the complex business processes. This automation will streamline activities for the achievement and improvement of

  • standardization

  • digital transformation

  • quality

  • service delivery

  • costs effectiveness

Three important elements to keep in mind when choosing a system to enable your Validation BPA are:

  1. Digitization vs automation. Will the system you implement provide true BPA, or will it provide a platform similar to your existing enterprise document management system? Automation of the business process and complementing business rules can provide a higher level of quality, integrity and efficiency of related deliverables and activities. There are many quality activities, decisions and business rules that must be observed as one navigates the validation lifecycle. Examples of these are change management, change impact assessment, deviation management, GxP assessments, risk assessments, scope management, etc. Automation must allow for the configuration of the business processes and rules that govern these activities to make the right decisions and trigger relative quality tasks based on said configuration. From that perspective the flexibility of a system is also crucial and must allow for variations that may exist from organization to organization without the need for customization. On completion, automation should allow for the elimination of a high percentage of manual intervention and administrative tasks. If the goal is to become paperless, then digitization is sufficient, but if higher quality and efficiency attributes are sought, true BPA is the key.

  2. Integration with other enterprise systems. 100 percent BPA may not be achievable with the validation system alone. In validation there are many possible handoffs of information from one business unit to the Validation business unit, and therefore automation of said handoffs must be considered. Automation of the information change of custody from one business unit to another should be easily achievable through the integration of enterprise systems such as LIMS, ERPs, eDMS, QMS and your Validation platform. The ease of integration between these systems depends on the similarity of their fundamental architecture. Purpose built applications such as the ones mentioned above are products designed to meet specific business requirement as defined by the users and share fundamental software architecture. This enables for logical messages to pass between desired systems, with a data-encoding structure understood by the systems being interfaced. If a validation platform is composed of third-party components connected together to perform the desired functions, the integration of such platform to other systems is limited by the nature of such architecture. In this scenario 100 percent BPA is not possible within the platform nor through the integration to enterprise systems.

  3. Support business change. The functionality and logic of purpose-built applications is managed and controlled by the provider of the application. Changes to internal quality processes or changes in guidelines and regulations may trigger the need for changes in the established Validation business process. For this reason, the Validation platform must facilitate changes in the configuration of business rules and addition of desired functionality if necessary to accommodate the change without the limitations imposed by third-party components or extensive development efforts.

Validator is an industry leading compliance solution. It is a true content management system, purpose built to allow companies to automate the entire lifecycle of validation, for any type of validation project.

About the author

Victor Zurita is the founder and CEO of Compliance Associates. To learn more about how VALIDATOR can help with your BPA, book a demo today.

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