How to leverage supplier involvement?

Does your?#digitalautomation?process hindering the change or deny improvements in your QMS?

Call it?#CSV?or?#CSA, the primary goal of?#automation?is to continually improve Organization’s?#qualitymanagementsystem?that is suitable for the design, develop and manufacturing of medicinal products to improve patient safety and wellbeing. Changes/updates to the processes and systems are some of the essential elements of the continuous improvement.?Digitization/Automation of processes should not hinder the change or deny improvement.

One of the five key concepts recommended in the?#GAMP-5 guidelines is “leveraging supplier involvement”. What does it mean? How to interpret it and practice in today’s world?

Biopharmaceutical industry is moving from one-time purchase of on premises products to end-to-end services (SaaS) available on the Cloud. So purchasing products and taking responsibility for the validation, implementation and maintenance is a history.

Utilising SaaS services available on Industry/Native Cloud will help the organisations to leverage suppliers involvement and eliminate the burden of?#Validation,#maintenance,?#servers,?#networking,?#datastorage,?#archival,?#BCP?and?#DR.

To realize the benefits of SaaS, the mind-set of the industry should also change. We have to maintain healthy relationship and treat service providers as “Partners” not as “Vendors”, because they are Part (ners) of our QMS continuous improvement.

How to choose a right partner?

My insights might help you to choose the right partner. Software technology and services providers should have following characteristics.

1.?Software technology

• Choose low code or no code platforms
• Services- available on Native cloud
• Easily and Highly configurable
• Easy to integrate with other systems
• System should be able to generate structured data
• Easy to tailor reports and dash boards

2.?Software service provider

• Well versed with GxP and industry requirements
• Matured QMS and ISMS with inculcated quality culture
• Software systems- developed and Validated
• Products and services- available on SaaS model
• Committed to improve software to align with your needs
• Willing to be a Partner in your growth and development
• Able to support during audits and inspections
• Customer centric

Conclusion:

Organisation must choose right partners and maintain long term relationship. Of course it is not rocket science, however, one should have thorough knowledge of the GxP requirements, updates on technological advancements. Right partners will help us to accelerate maturity of the QMS and satisfy the ultimate goal of achieving product?#quality, patient ?#safety? and?#dataintegrity. Selecting wrong technology and/or partner may impact the growth of the Organisation, it is very important step in your digital automation journey be prudent and wise, mistakes cannot be reversed easily.

#automation?#technology?#data?#computersoftware