Validation is defined by the Food and Drug Administration (FDA) as “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes”. Traditionally, companies capture the documented evidence on paper, typically using in-house formatted MS Word or MS Excel templates to create the content, and then printing and signing the document to establish a formal version. However, current IT applications and database technologies provide tools required to enable paperless validation. This whitepaper summarizes the benefits of using a software solution for validation within FDA/GxP regulated industries.
Standard benefits of introducing an IT solution
When introducing a software solution for validation, the following “standard” benefits which are inherent to IT solutions, are immediately realized, such as:
- Standardization; paperless validation requires defined validation processes and activities, which will be enforced by the software solution. This will avoid reinventing the wheel and ensure optimization and efficiency gains.
- Access anytime, anywhere; the use of a software solution will allow global access, through various kinds of devices. This facilitates teamwork and ensures progress of activities, thereby reducing the cycle time for validation.
- Elimination of paper; paper as a medium requires continuous activities by personnel related to printing, distribution and storage, and these activities can be eliminated by using a software solution. This will lead to efficiency gains and cost reduction, not to mention the positive environmental impact.
- Control; paperless validation enables visibility of validation activities and provides management with the required tools to control and improve processes. This leads to efficiency gains and cycle time reduction.
Traditional benefits of document and workflow management systems
Software solutions for validation need document and workflow management functionality as a basis. Besides the standard benefits noted above, this functionality brings the following standard benefits related to electronic document and workflow management:
- Quicker review and approval processes; automated routing of documents for review and approval, including electronic signatures, will speed up the document workflow by eliminating traditional manual activities related to distribution and signing of paper document versions. This reduces the cost and cycle time of validation.
- No loss of documents; the risk of losing a paper version during document routing or storage is eliminated when using a software solution. This facilitates compliance and
will reduce the time required to search for paper documents, which in turn reduces the cost and cycle time for validation.
- No paper archive needed; the introduction of a centrally and online accessible software solution will eliminate the need for a traditional physical archive for storage of validation documentation. Although a software solution requires an investment for IT infrastructure to ensure continuous availability and storage of electronic documentation, the reduction of costs related to traditional archive facilities and continuous manual labor related to archive management will lead to an overall cost reduction.
- Quicker searching and retrieval of documents; searching for paper documents requires a structured and continuously maintained indexing system, which requires a significant amount of manual labor in the case of larger organizations. A software solution for validation will facilitate instant retrieval of documentation based on any query. This reduces the cost and cycle time of validation activities and will ensure that documents are readily retrievable during an audit, as required by FDA/GxP regulations.
Benefits specific to validation
Besides the standard benefits related to paperless validation and document and workflow management, there are a number of interesting benefits specifically related to using a software solution for validation as follows:
- Enforcing the order and traceability of both documents as well as content; as depicted in the traditional V-model, validation activities and documents require a specific order and relationship, which can be established and controlled when using a software solution. Furthermore, a software solution makes the validation process and activities transparent, and eliminates the need to manually create and maintain a traceability matrix. By establishing the links between both documents as well as requirements, test cases and results, items can be tracked and subsequent actions assigned to individuals. This, in turn, facilitates compliance.
- Reduce the costs of validation; by eliminating the human activities required for preserving the order and relationship of documents and content.
- Reuse of content; in a traditional paper based system, validation documents tend to be rewritten ‘from scratch’ each time. Employing a software solution provides the ability to easily re-use previous content i.e. requirements, test cases, etc. which, in turn, greatly reduces the time and effort involved in producing validation documentation.
- Focus on the actual validation work; by eliminating the manual labor related to workflow and document management, validation personnel can fully focus on the actual job of validation, entailing planning, specification, testing and reporting. This facilitates compliance and reduces the cost and cycle time for validation.
- Management reporting; one of the major challenges in managing a validation project is accurate reporting on open activities, especially documents in the process of review or approval. Software solutions typically provide a real time view on the progress of activities which enables management to make timely decisions and take appropriate actions in an efficient manner.
Although the benefits of paperless validation compared to the traditional way of working may be clear, it can still be a challenge to convince stakeholders of an organization for the need for investing in a paperless validation solution. When evaluating the IT budget and prioritizing solutions, the benefits of IT solutions supporting primary business processes are typically perceived as more tangible compared to a quality management solution like a validation lifecycle management system. However, the aforementioned summary of benefits should provide solid reasons to justify the investment in paperless validation.
Rescop provides global consulting services and software solutions for FDA/GxP compliance and has extensive experience in setting up business cases for paperless validation solutions. In addition, Rescop can provide real world examples of cost and cycle time reduction based on implementing and using paperless validation solutions in practice.
Author: B. Aalbers, Chief Technology and Operations Officer, Rescop Inc.