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Validated Hosting: Us versus Them
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Jan 11, 2011
Are you looking for space, processing powering, uptime, elasticity, security, data integrity, and regulatory accountability and compliance? If so, you should starting looking for a TRUE validated cloud hosting provider. Unless you work for GE it's pretty unlikely that you'll be able to convince Amazon or Google to qualify their hardware and systems for HIPAA/HITECH or FDA Compliance. Will they sign a business associate agreement?  Unlikely. Further it's highly improbable that they’d support you in time of an audit. Amazon and Google offer great services but they are simply not tailored to the regulated industries. For about the same price, you can enjoy all of the benefits of an Amazon or Google while also enjoying peace of mind. SidusBioData has invested the time and resources to fully qualify their Datacenter and Cloud while creating an EHNAC audited Quality System that is second to none.
Sidus BioData to Exhibit at Medica Conference in Dusseldorf
By
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
, Business Development Manager: Nov. 2, 2011
Sidus BioData, leading provider of Compliant Cloud Hosting for Life Sciences and Health IT companies across the globe, has been invited by the Maryland Department of Business and Economic Development’s Biotechnology Center (MBC) to exhibit at the  MEDICA 2011 tradeshow, the world's largest event for the Medical Sector. Sidus' Validated Hosted Solutions and Services will be showcased at the conference taking place in Dusseldorf Germany, November 16-19, 2011.
Read more: Sidus BioData to Exhibit at Medica Conference in Dusseldorf
Regulated Hosting: Questions and Answers Session with Stephen Ferrell - GAMP Special Interest Chairman
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager : Oct 26, 2011
Hosting was once the domain of websites, poetry blogs, and small businesses. In the last 10 years the industry has taken hold and an outsourced infrastructure is now the norm for corporations big and small, local and global. The added burden placed on companies regulated by 21 CFR Part 11, Annex 11 and the associated GMP’s, has caused many to shy away from Compliant Hosting. I recently had the opportunity to discuss this topic with Stephen Ferrell. Stephen is the outgoing chair of the GAMP IT Infrastructure Special Interest Group, he leads the V&V group for a local BioTech company, and he supports Sidus BioData as a Regulatory Advisor.
Say Goodbye to Validation and Hardware Costs
 By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Oct 10, 2011
Whether you are an established biotech, pharmaceutical or medical device manufacturer or are simply getting your feet wet, it’s inevitable that your business will need some combination of the following systems:
The Biotech Industry Should Better Understand the Consequences of a non-Validated Computer System
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager:Â Sept. 09, 2011
If you are a Medical Device developer, a Biotech firm or Pharm
aceutical Manufacturer, you are required to follow either 21 CFR Part(s) 210 & 211 or 21 CFR part 820. In tandem with 21 CFR Part 11, all of the computer systems used to support your manufacturing and design processes require validation. Often manufacturers make the mistake of attempting to claim that their computer systems are purely reference tools and that paper reigns. This approach has the potential to mislead, confuse and ultimately break the law.  There are several citations issued by FDA including:
“Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 C.F.R. §820.70(i) (Production and Process Controls - Automated Processes).”
Compliant Hosting for HIPAA and HITECH – Making the right choice.
These days, it isn’t hard to find a datacenter claiming “HIPAA Hosting” or “HITECH Hosting.” What is hard to find is a datacenter that truly understands and adheres to the guidelines surrounding HIPAA compliance. The exception, is Sidus BioData. Our datacenter is in full compliance with all health data regulations – we have a regulatory roadmap and quality manual to prove it, something I can say with certainty (because I have done my homework) that most others do not.
Read more: Compliant Hosting for HIPAA and HITECH – Making the right choice.
Quality Regulated Hosting - a simplified approach to data security and compliance services for the Life Sciences Industry.
When 21 CFR Part 11 was introduced in 1997, it created in equal measure - confusion and consultants. Fourteen years on, the confusion has largely disappeared and while regulation remains under review the chances of wholesale changes are highly unlikely. The cottage industry of consultants remains though, eager to serve for three months and leave a pile of validation protocols in their wake. While there are many competent hardworking consultants out there, there are many yet, who by virtue of their profession, have never sat in front of FDA or EMEA, have never had to defend last weeks, last month, or last years validation package.
What Makes a Compliant Data Center?
Simply put, a compliant data center is a data center that conforms to a set of regulatory rules, specifications, standards or laws. Conforming to mandated laws or standards to meet federal and commercial regulations requires a considerable investment in, infrastructure, personnel and services. However, due to the significant cost, many commercial or private data centers have not made the proper investment in the physical, environmental and operational controls and services to meet t
he minimum regulatory requirements.
The most regulatory requirements map to industry best practices:
- Redundant Power and Cooling
- Intrusion Detection
- 24x7x365 Monitoring and Staff
- Backups and Documented Policy and Procedures
This is just the start, here is an example of a Compliant Data CeterÂ
IT security and Information Assurance professionals tasked with ensuring their information systems meet compliance requirements, have limited options when it comes to selecting a compliant data center.
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Outsource Solutions for HIPAA Compliance
Last February, President Obama signed into law the $19.2 billion Health Information Technology for Economic and Clinical Health (HITECH) Act to accelerate the process of digitizing electronic health records (EHR) in the United States. Under this law, hospitals and healthcare professionals who demonstrate “meaningful use” of a certified EHR by the year 2015 will become eligible to receive millions of federal dollars in incentive payments, and those who do not comply could be penalized. In addition, healthcare organizations must comply with related security and privacy requirements. This has proven both a powerful motivator and source of great concern for many healthcare professionals across the country. Â
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