Life science companies face a growing number of business and regulatory pressures, including the broader and yet more stringent nature of government regulatory controls, along with heavy penalties for noncompliance.
Compliance and quality management issues resulting from these pressures include the increasing cost of compliance, ensuring avoidance of business interruptions and preserving stakeholder value, and maintaining company image among public and government groups and influencers. Complex organizations and processes resulting from growth, new markets, mergers, and acquisitions still need to deal with competitive pressures to be able to respond more quickly. Compliance with new and evolving regulations and guidances (e.g., pharmacovigilance, privacy, "uncertainties" regarding the future of 21 CFR Part 11) becomes more challenging as time goes on.
Industry's response to these pressures has been an increased emphasis and related investment to ensure regulatory compliance, as well as a reevaluation and reprioritization of how best to deal with regulatory requirements.
How Patni Can Help
With a goal of introducing and improving overall quality management, Patni assists you in addressing governance, organizational, operational, and infrastructure support in response to US FDA and related global regulatory compliance issues. Patni executes diagnostic engagements that identify appropriate gaps and develops action plans to close the gaps, and provides implementation support to complete the tasks necessary to close the gaps. The current state of your organization can be assessed and then compared to industry best practices, leading to the development and implementation of improvements in organization, process, tools, and metrics.
Establishment of an integrated compliance philosophy across the regulatory spectrum (e.g., Sarbanes-Oxley (SOX), Health Insurance Portability and Accountability Act (HIPAA), GxPs) is a desirable goal, and one which Patni helps you achieve through the development and implementation of harmonized policies, procedures, and practices.
A Quality System (QS) reflects a disciplined approach to achieving quality standards defined by your organization in order to ensure compliance with business and regulatory requirements. Patni helps craft an appropriate enterprise-wide compliance and QS framework that outlines management commitment to quality services and solutions and provides a map of how commitment is being realized through organizational roles and responsibilities, standard operating procedures (SOPs), tools, and metrics. Patni employs a maturity modeling approach, where predictability, effectiveness, and control of your organization's processes are driven to improve as your organization moves up defined maturity levels. By further leveraging risk management principles, your organization realizes reduced costs, optimized resource allocation, and ensured regulatory compliance and business continuity. An established standard such as ISO 9001:2000 can be helpful in forming the basis of a QS; and principles outlined in the Software Engineering Institute (SEI) Capability Maturity Models (CMMs) ® can be leveraged to define the various maturity levels of each of the QS components.
Patni leverages our technological and regulatory experience and expertise to promote the application of quality management principles within your IT organization. Risk management and regulatory (e.g., GxPs, 21 CFR Part 11) compliance efforts become integral components (versus add-ons) to your computer system validation approach. Patni encourages the use of Quality Coaches as independent resources focused on and dedicated to ensuring the regulatory compliance and quality of the resulting computer system or IT project.
Patni Focus Areas
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