A structured and defined validation approach is a backbone for successful implementation of the project and identification of issues at an initial stage of product life cycle in regulatory environment. Innovative and precise CSV practices ensure more effective, efficient and user friendly system and helps in generating the much needed confidence for critical success factors of data integrity and user defined access. The main objective of a systematic computer system validation is to identify the errors/ bugs at an initial stage and prevent the same from reaching production environment. There might be a serious consequences of software issues in a regulated environment including financial losses and manufacturing shut down. That is why FDA regulations mandate a systematic Computer System Validation to provide a high degree of assurance that product is meeting its predefined specification and quality attributes.
No Cutting Corners On Validation:-
Cutting corners while performing a validation might save a little amount on short term basis but might leads to potential impact and serious noncompliance of not performing the validation correctly which can also hamper the production and possess serious risks related to patient’s safety. The main emphasis of FDA is to not only perform the validation, but perform it in the correct manner.
A Realistic Approach:-
At the same time, a realistic approach is also essential to achieve the goal of optimal test coverage within a reasonable period of time. The designed tests scripts should be precise and contain the key steps in a sequential order to execute the activity in a structured manner. Test results should be measurable so that the validation team can record the coverage to gain maximum confidence.
Convinced On System Capabilities:-
Internal testing or more precisely an internal validation that covers the regression testing is of utmost priority to generate confidence before exposing the system on client’s environment. System validation engineer needs to be well convinces of the quality of the software they are validating.
In a broader way, a structure approach on CSV not only helpful to ensure smooth implementation of the proposed system to identify errors and extreme scenarios to make the system more user friendly but also ensure readiness of the regulated company to face CSV audits. CSV related deficiencies are major area of concerns in a regulated environment. According to Lab compliance report, ““Just in 2007-2010, there have been more than 30 warning letters with deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies”
Sarjen offers a broad range of Computer System Validation (CSV) services to ensure a validated system within a reasonable time period. Our team of experts follow a controlled development and implementation approach to computer system validation to helps clients in ensuring the integrity and reliability of the system.