“The Life Sciences industry is highly regulated with compliances which are onerous. Any vigilant intervention would increase costs without 100% assurance. The scale of operation needs application like [Harness] RISCC to address ever increasing compliance needs.”
Dr. Nitin Borkar. CEO,VerGo Pharma Research
1. What industry obstacles did you face at Novartis prior to using Harness RISCCTM ?
Ans: As a head of global R&D in India our goal was to develop a USFDA compliant program for product development. the multitasking and multilocational teams involved needed a system to be transparent to our entire global R&D regarding compliance and material availability. the expiration of the calibration on equipment , reference standards, reagents and actual inventory management was a major challenge. the old classical quality by inspection (a policeman approach) was mandatory and with 200 products in pipeline at 3 global locations it was nightmare.
2. How has Harness RISCCTM improved your compliance levels?
Ans: All the QA get alerts and action levels for non compliance and also the product supply planning errors have been eliminated.
3. What were the key benefits in solving these obstacles that led you to implement Harness RISCCTM when starting VerGo?
Ans: VerGo is a contract research organization which have to meet challenges from several clients operations running more smoothly, lowered costs, etc. (proven results)
4. In the past you have referred to Harness RISCCTM as a "Universal Glue" can you please elaborate on this?
Ans: Harness RISCCTM is independent of IT platform and software. it can work seamlessly with LIMS and ERP to give the client ease of connectivity to all its operations.
5. Through your experience at both Novartis and VerGo please explain how you believe the life science industry is able to benefit from Harness RISCCTM as a whole?
Ans: the life sciences industry is highly regulated sector with compliances which are onerous. any vigilant human intervention would increase the cost without 100% assurance. also the scale of operation in such a industry would need application as Harness RISCCTM to meet the ever increasing compliance needs.
“Harness Solutions invested in the process and technology to our satisfaction; the key selection criteria were the commitment demonstrated to meet business needs in compliance to all regulatory requirements.”
6. From business perspective, how has VerGo benefitted from implementing Harness RISCCTM ?
Ans. Our warehouse with 1000 items were manned by one FTE and with increase in activity the system has increased productivity and thus decreased cost. the major advantage is the availability of total inventory status instantaneously.
7. When did you decided to integrate Harness RISCCTM in your business practice model for VerGo?
Ans. We started very early to consider the RISCC solution. the confidence which our clients get regarding the transparent approach of compliance from VerGO is the major success get with installation. that's the "ah ha" moment.
8. What benefits do you see for VerGo using Harness RISCCTM in future?
Ans.The scalability and flexibility of the system to fit ever growing needs of VerGo
“Harness Solutions is easy to work with. The software was easy to roll out and the tagging process is very user friendly and easy.”
9. What three words do you feel best describe Harness RISCCTM
Ans. Compliance. Cost effectiveness and Universal.
10. Please describe your experience with implementation and integration of the software by Harness Solutions team?
Ans. Harness solutions is easy to work with, nonintrusive, quick time to market.
The software was easy to rollout at VerGo and also the tagging process is very quick & user friendly . 21 CFR part 11 compliant software made it fast and easy for us to validate.
11. Please explain Harness Solutions' training module and customer support component?
Ans. The training module is very informative, very detailed , very easy to use it's like a PIC (Product identification charts) approach of IBM. the customer support and training was efficiently handled. easy to any other customer to take it rollout.
12. How has Harness RISCCTM enhanced or improved your procedures?
Ans. Eliminate manual processes, zero human error risk, I have seen people finding out things which were lost.
13. What are your employees thoughts and feelings on using Harness RISCCTM
Ans. The VerGo team has embraced the new system and has shown great interest to adopt due to the great dashboard and ease of use the benefits are easy to demonstrate thus giving better control over their compliance challenges.