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How to Avoid Electronic Data Integrity Issues: 7 Techniques for your Next Validation Project

Regulatory agencies around the globe are causing life science companies to be increasingly concerned with data integrity.  This comes with no surprise given that Guidance Documents for Data Integrity have been published by the MHRA, FDA (draft), and WHO (draft).  In fact, the recent rise in awareness of the topic has been so tremendous that, less than two years after the original publication, the MHRA released a new draft of its guidance whose scope has been broadened from GMP to all GxP data.

How to Validate Computerized GxP Systems in the Life Sciences

Maintaining the Validated State of Regulated SaaS Applications: A Case Study in the Montrium Cloud

For life science companies, there are several considerable benefits to using   applications to manage operational information. However, a SaaS-based platform also presents unique challenges for both the solution provider and the life sciences company (end users).


9 of the Best Online CSV Resources for Pharma Validation Professionals


Software Vendor Selection: Selecting the Winning Vendor

If you asked a pharmaceutical organization 20 years ago how they select suppliers and partners, they would most probably tell you that it was based on price, location and internal preferences. However, as government, regulatory agencies and industry put more emphasis on safety, quality and compliance, evaluating and selecting the right software vendor has become much more critical and complex.


Software Vendor Selection: Requesting Proposals & Quotes

The RFP phase of the vendor selection process is a critical step to successful acquisition of electronic systems. At this stage of the process you’re looking to narrow down your potential list of vendors so that you can get more specific information around their company, the culture, their team and most importantly pricing. Ultimately when searching for new systems and vendors, you’re not only looking for the perfect solution, but also the perfect partner.


Software Vendor Selection: The Pitfalls and Successes of Vendor Demos

Vendor software demonstrations are one of the critical elements of software evaluation, and must be properly planned to get the most value. You as a software buyer could miss a huge opportunity by letting a software salesperson dictate the flow of the demo. Software demonstrations are there to show you how each product would meet your business needs and work in the context of your organization. Without the proper planning and control, the exercise of participating in a software demonstrations can quickly become redundant and a waste of time for your vendor selection team. Time is valuable, so getting this right the first time is important.


Software Vendor Selection: Finding the Right Vendor

As we progress through the New Year, many companies and departments, armed with fresh budgets and new business needs, are starting to search for software solutions to improve their business. However, with the recent boom in the enterprise software market, finding and selecting the right software and the right vendor can be more challenging than ever.

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