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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
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

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.