How to select Software for a Regulated Environment

Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This presentation will give the answers to these questions; plus show you ‘hidden’ issues that will save you from:

Selecting and implementing the wrong system that ends up costing more in trying to get a ‘square peg to fit in a round hole’ efforts, often resulting in cost and time overruns and finally ending up not being used by the user community.
Duplicating data in systems with overlapping functionality resulting in both duplication of effort and higher incidence of errors
Inadvertently acting as the vendor’s beta site
Putting unnecessary work into meeting regulations
Even though this presentation focuses primarily on software, the hardware required will also be addressed.

Areas to be Covered:

• How to buy or to build?
• Why not stay with the existing solution?
• Who should be part of the evaluation and decision team?
• What is involved in the assembly of selection requirements?
• What is the vendor evaluation process?
• How does the new software fit into your current environment without causing errors and duplication?
• What are the regulatory requirements for:
• An In-House Build Solution?
• A Commercial Off The Shelf Solution?
• A Hosted Solution
• Hardware environment
• Implementation Consultants?
• How do you use Risk Assessment?
• How do you manage consultants and vendors?
• How do you leverage the vendors’ methodology?
• How long does it take and what will it cost?

Who Should Attend:

• CEO’s
• Regulatory VPs
• Quality VPs
• IT VPs
• Database Administrators
• System Administrators
• Validation Specialists
• Security Specialists
• Regulatory Affairs professionals
• Quality Managers
• Quality Engineers
• Small business owners
• GxP
• Consultants

Course Director: ANGELA BAZIGOS ‎

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.