Effective validation begins with thorough planning and a sound
methodology. As the FDA states in their Guidance on General
Principles of Process Validation: “Process validation is establishing documented evidence which provides a high
degree of assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality characteristic.”
The basic principles of quality assurance have as their goal the production of
products fit for their intended use. The principles may be stated as follows:
- Quality, safety and effectiveness must be designed and built into the product;
- Quality can be inspected or tested into the finished product;
- Each step of the manufacturing process must be controlled to maximize the probability that the finished product meets all quality and design specifications.
Validation Evolution
The regulations which provide governance
of computer systems validation are
evolving everyday. Emerging regulatory
requirements and 483 warnings have placed considerable demand
on companies to ensure that all validation activities are conducted
in compliance with current mandates. The current evolution
in changing regulations has caused most organizations to adopt
very fragmented, piecemeal approaches to validation. These
approaches have resulted in more costly validation projects, even
for "off-the-shelf" technologies.
Through the understanding and application of lessons learned and best practices, organizations can ensure that consistent policies will help reduce risk, decrease validation costs, and improve systems quality.
Validation Best Practices
Validation is a heavily documented process that requires careful planning and execution for successful implementation. The following best practices will ensure 100% success for your next project.
- Draft a validation master plan. Validation
planning is the first step towards successful validation. A
validation master plan is the foundation of successful validation.
- Establish an effective training program. Validation
requires a knowledgeable staff that has the relevant competencies
to perform well constructed and documented audits of the system
and processes.
- Leverage electronic document/content management technologies. Validation
is a living process. For the life of the site, process,
equipment or software, validation documentation must be continually
updated to ensure quality control. All validation documentation
should be stored within an electronic document management system
and be placed under version control and change control processes.
- Draft a written validation protocol. The
validation protocol is a key document that is essential to any
validation initiative. The validation protocol document
establishes the validation program, defines the program responsibilities as well as specific requirements for each initiative. The protocol
should also define the re-validation process.
- Develop comprehensive validation policies and procedures. This
may seem like a no-brainer, but it is an often skipped process in
many validation programs.
- Conduct validation according to intended use. It is important to establish a set of user requirements for the system so that all validation activities can be performed in accordance with intended use.
