Risk based approach to realize savings while implementing regulated software.

Pharmaceutical, Life science, Heath care and FMCG are few of the industries need to satisfy various regulatory and quality authorities to achieve compliance. These industries are slowly and steadily transforming their manual processes towards automation by implementing software solutions like Quality Management System, Audit Management System, Document Management System, Training Management System, Pharmacovigilance software, Dossier software etc. Automation brings various benefits like reduce time, cost, efforts, errors and enhance control, visibility, transparency and productivity. Hence, you need a Risk based software validation

But still many companies resist implementing software solutions. Reason is not the cost but the required time, cost and resource for software validation. If not validated properly it may cost more than the actual cost of software solution.

Despite these deterrents there is huge demand of software solutions in regulatory environment, the FDA also has encouraged by promoting risk based approach to validation.

Risk based software validation approach of FDA

In the Guideline on General Principles of Process Validation the FDA defines validation as “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 attributes.”

Basically there are three motivational factors responsible behind the shift in risk based software validation :

• With risk based approach companies can more deeply test the areas of software will improve product quality and patient safety
• Overall validation cost will reduce and efficiency will increase
• Will boost more innovation in this area

Risk based software validation

Risk based validation ensures data integrity, control, audit trails and effective processing to shape various metrics report. Risk based validation defines formal Risk Management Plan that details the risk assessment and risk mitigation activities during not only the implementation of the system but during Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing phases.

The next step in risk based software validation is classifying and prioritizing the risk on the basis of impact, likelihood and detection.

Realizing savings by choosing the right vendor

Your processes are unique so you need specific solution for your business hence selection of right vendor is very crucial. While selection of vendor you should assure few necessary things like domain knowledge, industry experience, ability to understand your pain areas and ability to respond that accurately.

Sometime it happens that there is a gap in what you want and what you explain to your vendors in that case if the vendor has thorough industry experience then he could easily identify your requirement and suggest you the best possible solution against that.

So by selecting a right vendor you can save your precious time/cost/effort/resources required in validation of system.