Life Sciences companies operate in a highly regulated environment that is continually growing and evolving as regulations and guidance criteria change.  Increased demands for compliance, even at basic levels, require sponsors to identify, manage, and monitor risks during all phases of development to ensure adherence to, and audibility against regulations such as Sarbanes-Oxley, 21 CFR Part 11, and HIPAA.

Adding to these pressures are advancements that have introduced computerized systems and related technologies and procedures into every facet of the business.  Companies have no choice but to significantly invest in achieving compliance across processes and computerized systems while simultaneously continuing to develop new products and maintain profitability. 

The Intrasphere Solution
Intrasphere leverages 10-plus years of experience and deep industry expertise to work with your company's unique compliance and quality situation objectively. We uncover your needs and priorities, clearly define project requirements, and tailor our services accordingly by using practical approaches to compliance and validation, providing excellent client service, and strong project management.  Our services and solutions address the following compliance-critical areas of business, among others:

• Sarbanes-Oxley
• 21 CFR Part 11
• Risk Management (security and operational controls)
• Computer Systems Validation (quality assurance and quality control)
• Business Continuity Management

Our professionals are a dynamic group of pharmaceutical engineers, consultants and business specialists focused on this industry, compliance and developing technology solutions that specifically address the unique needs of our clients’ business.  We are dedicated to helping the people we work with thoroughly understand and comply with process and computerized system standards, regulations, and policies and procedures.  We participate in key industry groups, and are experts about and well aware of the latest issues and events that directly affect our clients’ practices today, and in the future.  

Our Approach to Compliance
Our regulatory compliance solutions focus on identifying root causes.  We implement programs that help organizations achieve consistent and repeatable compliance programs applicable to any regulation, guidance or operating standard.  Intrasphere delivers results:

• Governance, risk management and compliance solutions
• Risk-based computerized systems validation programs
• Quality management systems gap/risk assessment and roadmap
• Quality management systems implementation
• Standard operating procedures (SOPs) and Guidelines development
• Computerized system qualification and testing
• Audits, gap/risk assessments and corrective action plans
• Training program evaluation and development
• Change management programs
• Enabling technologies
• Industry benchmarking
• Instructional development
• Organizational effectiveness
• Process development
• Process reengineering
• Program management office (PMO)

Our services and solutions include a full range of automated tools, computerized system validation services, and procedures to help enable compliance throughout the various departments and stages of business. 

Intrasphere specifically helps clients achieve and maintain a competitive advantage by:

• Developing state-of-the-art solutions for compliance
• Establishing priorities
• Identifying specific actions necessary to become compliant
• Streamlining the validation process and validation management 
• Minimizing the effort required for on-going regulatory compliance
• Improving operational efficiency

Beyond compliance, Intrasphere’s solutions and dedicated team of professionals enable users to spend less time gathering and processing information, and more time analyzing and improving business performance - a key competitive advantage in this complex and time consuming area of business.