The life science industry is witnessing a transforming technology landscape with a growing number of pharmaceutical regulations. This is challenging but puts forward opportunities concerning innovative and new procedures, assuring internal harmony, and creating myriad expert executions in automated life science validation.
Paper-based validation incurs business losses
The lack of standardization, and incompatible rendition across policies and regulations, incur huge expenses for companies. Paper-based validation relates to time-consuming audits, delays in approvals, uneven documentation, inconsistent reviews, and difficulty in tracking. This creates an imbalance and lags in monitoring, and also negatively affects the business ROI.
Computer validation in life sciences
The computer system validation in life sciences is an excellent way of empowering organizations to simplify the challenges associated with their business validation. The computer system validation for life sciences features an automated validation strategy. The strategy associates proper planning, coaching, and executing via an agile procedure, thereby yielding greater value for pharmaceutical clients.
Systems and processes accountable for validation
In the life sciences field, the following systems and processes require validation.
- The computer systems
- The laboratory tools and instruments
- Analytical procedures implemented
- The manufacturing equipment and tools
- Packaging
- Shipping
- The method of cleaning and sterilization
Conventionally, the validation process was paper-based. The paper-based validation is labeled as inefficient because of its time-consuming processes and the large number of resources required to print, scan, review, and approve documents. The paperless validation system eliminates the inefficiencies associated with paper-based procedures. Henceforth, the rising popularity and widely practiced automated life science validation are given so much value around the world because of their benefits.
Basic benefits of automated life science validation
A business can experience the following basic benefits when an automated validation solution is incorporated.
- Reduction or elimination of manual errors
- Enhanced compliance by almost 75%
- Decreasing time for validation lifecycle by almost 35%
- Curtail GTM time by 20%
- Better risk management solution by identifying risks associated with business regulations, functions, and other requirements
- Improved auditing process
- Better ROI
Automated validation saves time
The automated life science validation scripts can perform validation testing via software tools automatically. This automatic approach can be significantly time-consuming. The software testing tools eliminate the need to manually implement complicated scripts for every phase. Life sciences companies can incorporate the tests easily with the click of a button. It is just not the time-saving aspect that is highlighted, but the positive impact it creates is of greater value to the business.
Conclusion
Validation is an international regulatory requirement for the life science sector. The concept is approved by the FDA as the standard procedure for establishing documents. The documented evidence offers an assurance that the particular system, computer device, or other life science equipment will cater to the demands of the intended use. In the present-day life science industry, every system, including computers, equipment, and other processes involved requires validation. The growing use of the latest digital technologies in the life science industry makes automated life science validation solutions necessary. The validation process is the evidence that the computer or software application will function abiding by the good practice (GxP) guidelines and regulations.
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