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Obtaining IQ Validation Evidence for FDA Compliance when Leveraging Cloud Services

In the highly regulated pharmaceutical and life sciences industries, even small variances can cause damaging repercussions. This is why the FDA robustly enforces the qualification measures and strict validation processes specified in the CFR. To obtain FDA approval or pass an audit, one of the first steps that regulated companies must complete is equipment validation. [...]

By |April 13th, 2020|Cloud Computing, Life Sciences|Comments Off on Obtaining IQ Validation Evidence for FDA Compliance when Leveraging Cloud Services

Simplify FDA Validation of Mission Critical Apps in the Cloud

Life Sciences Company Eliminates IT Distractions by Leveraging the Expertize of a Cloud Service Provider to Design, Build, Manage and Implement a Validated, Secure, Responsive Cloud-based MES System For companies focused on ramping up quickly, the prospect of diverting or procuring additional IT resources and spending time designing, building and managing regulated IT infrastructures doesn’t [...]

By |February 26th, 2020|Cloud Computing, Life Sciences|Comments Off on Simplify FDA Validation of Mission Critical Apps in the Cloud

The Power of the Custom Cloud Solutions

Absolutely no two businesses are created in exactly the same way. Even two operating in the same industry have different operations. From an information technology standpoint, this used to be one of the biggest hurdles for most organizations to overcome. This is because there was no single approach to building the perfect infrastructure that worked [...]

By |February 26th, 2020|Cloud Computing, Life Sciences|Comments Off on The Power of the Custom Cloud Solutions

How CMOs Can Leverage the Cloud & Pass Benefits onto Customers

In the biopharma industry, it has become commonplace for companies to outsource both manufacturing processes and research efforts. By relying on contract manufacturing organizations to make their products and conduct research, they eliminate the costs associated with purchasing and maintaining a manufacturing plant and/or research lab. In fact, the reliance on CMO outsourcing is expected [...]

By |February 26th, 2020|Cloud Computing, Life Sciences|Comments Off on How CMOs Can Leverage the Cloud & Pass Benefits onto Customers

Cybersecurity Needs to be a Priority for Life Sciences Companies

According to one recent study, the frequency of cyberattacks aimed at health care and other life sciences organizations grew by 2390% between 2009 and 2017. Over the last 10 years, approximately 38% of all attacks targeted these types of companies - by far the highest number of any industry. The Growing Threat of Cyberattacks Whether [...]

By |January 24th, 2020|Life Sciences, Cybersecurity|Comments Off on Cybersecurity Needs to be a Priority for Life Sciences Companies

How Cloud Validation Simplifies Compliance for Life Sciences Industry

Everyone knows that in a short amount of time, the cloud has changed the way we do business - for the better and for all time. We've entered into a bold new era where communication and collaboration are easier than ever. It's now possible to be just as productive at home (or halfway across the [...]

By |September 27th, 2019|Life Sciences, Cloud Computing|Comments Off on How Cloud Validation Simplifies Compliance for Life Sciences Industry

Life Sciences Company Eliminates IT Distractions with Secure, Responsive Cloud-based MES

For companies focused on ramping up quickly, the prospect of diverting resources and spending time building and managing IT infrastructure doesn’t make sense. Trusting an expert in technology to design and manage infrastructure and applications is the better option. In a ground-breaking case, Outer Edge Technology delivered best-of-breed MES and other mission-critical applications through cloud-based [...]

By |March 14th, 2019|Life Sciences|Comments Off on Life Sciences Company Eliminates IT Distractions with Secure, Responsive Cloud-based MES

Increased Risks from Macro-Based Malware

Increased Risks from Macro-Based Malware Microsoft Office applications use macros to automate routine tasks. However, macros can contain malicious code that can be used to exploit vulnerable systems. Recently, there has been a resurgence of malware that is spread via macros. Individuals and organizations should proactively secure systems against macro-based malware. Users and administrators are [...]

By |March 7th, 2019|Life Sciences|Comments Off on Increased Risks from Macro-Based Malware

Risk to Reward: How Businesses Turn End of Support for Microsoft SQL 2008 and Windows Server 2008 into Strategic Advantage

End of support puts businesses at high risk of security breaches Support for Microsoft’s SQL Server 2008/2008 R2 and Windows Server 2008/2008 R2 end on July 9, 2019 and January 14, 2020, respectively. These dates signal the end of regular security updates, putting companies using them at risk. Unfortunately, many business leaders are unaware of [...]

By |December 11th, 2018|Life Sciences|Comments Off on Risk to Reward: How Businesses Turn End of Support for Microsoft SQL 2008 and Windows Server 2008 into Strategic Advantage

Life Sciences Startup Accelerates Time to Market Working With Industry Specialist Managed Services Provider

With an FDA approval expected in the near term, a Life Sciences company needed to ramp up its manufacturing capabilities. Operations needed to be established quickly which meant a short runway to get software validated and infrastructure designed, qualified and running. The IT team of the San Francisco based biotech was already stretched thin, evaluating [...]

By |October 31st, 2018|Life Sciences|Comments Off on Life Sciences Startup Accelerates Time to Market Working With Industry Specialist Managed Services Provider

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