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ROI CalculatorIn regulated industries such as pharmaceuticals, medical devices, and food production, validation has become a vital process for engineering professionals. It is a requirement that needs to be fulfilled in these industries if best quality is to be achieved.
Quality engineering means that the quality is not only in the final product but that assurance has to be ensured in each production stage. Quality has to be built into each process that is involved in the creation of the product. In 2011, the FDA published guidance on the validation of processes. In 2015, this was followed by similar publication by PIC/S and EMA. The pharmaceutical industry is adapting to this changed approach to validation.
Essentially, the validation process entails a combination of different kinds of activities which have to be undertaken as part of the entire life of the project. Process validation is formally defined as “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Validation, however, follows a strict methodology consisting of various phases of validation.
The validation process includes an endless feedback loop during validation of systems, devices, and software through its entire validation process. It covers all aspects from design development to post-validation verification. Validation process consists of three essential stages, which are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as per FDA guidelines formalized in 2011.
Validation process is a necessary part of compliance in various companies operating in pharmaceutical and medical device industries. Regulatory institutions such as FDA and EMA need documented evidence of validation in accordance with the requirements set by them. However, non-regulated industries profit from implementing validation practices.
The advantage of the validation process is that it helps in meeting all compliance requirements through verification of validation expectations for the assessments, validation products, and implementation requirements during the entire usage of the system. Quality management systems benefit directly as validation provides documented evidence that processes operate consistently within established parameters, helping identify critical quality attributes, creating the foundation for continuous improvement initiatives.
Inadequate audit preparation results in unnecessary costs and loss of confidence from stakeholders. Several audit failures occur because some companies fail to provide comprehensive traceability documentation and this becomes even more pronounced when there are integrated processes or software platforms involved. Those companies that are ill-prepared usually end up paying more than expected fees, not to mention the internal control weaknesses that may arise from not preparing properly for the audit process.
Unlike the on-premise system where the internal team has to validate the software environment and ensure that proper change control is adhered to, cloud computing services are usually pre-validated. However, cloud computing services have their own challenges because they are known to initiate updates without informing their clients.
