Quality System Expertise

Quality System Expertise for Quality Document Development

Gap assessment Overall quality system development

SOURCE LIFE SCIENCE CONSULTING LLC understands the critical relationship between business performance and product quality. In addition, it works with all levels of your organization to maintain a balance between those objectives. We recognize that one size does not fit all, so our experts, who hail both from the industry and FDA, craft solutions expressly tailored to your organization's capabilities which will serve as a solid foundation to meet your needs today and as you evolve. Regardless of the industry involved or the process being evaluated, we work alongside your organization to generate solutions that will accelerate the development and implementation of effective quality systems.

SOURCE LIFE SCIENCE CONSULTING LLC has the ability to create a quality management system (QMS) which is both compliant and effective without being onerous requires strong insight into both the drug development and compliance processes. Our end-to-end expertise allows us to develop systems which will withstand regulatory scrutiny without adding unnecessary overhead or compliance risk to your operation. Our consulting quality and technical teams are well versed in the details of designing and implementing GxP systems. Whether your needs are GLP, GDP, GEP, GMP or GCP we have the expertise to design, evaluate or remediate your GxP system. Unlike other consultancies our experts will work with your team to identify deficiencies in your current QMS, then recommend solutions which will fit the capabilities of your organization, including training your team on the fundamental basis for each QMS.Our experts will assess your current systems, providing a gap analysis to these new standards and a roadmap to demonstrating compliance.

Our team of experts are honed in designing tailored Quality Management Systems, incorporating principles for Quality Risk Management and Data Integrity, to ensure an integrated PQS and compliance with regulatory requirements and best practice standards.

Our experts will hold your hand in designing best possible Quality Management System by carrying out remediation in order to meet your changing needs and the demands of evolving regulatory requirements and best practice standards, including SOP development.

Source life science consulting LLC team of consultants will Identify gaps in your Quality Management Systems and supporting systems that could impact on product quality or regulatory compliance, which could present potential quality or compliance risks for your business.

Our International’s team of Quality compliance consultant will provide support services to your organisation from both high level QA strategic planning and decision making.

Our consultants are particularly skilled in assessing and enhancing quality assurance and controls-from the way technical issues are handled to the organizational structure of quality units.

Leveraging vast knowledge and experience,Source life science Consultants assists clients in:

  • Evaluating written procedures and standard operating procedures,Helping to interpret regulations in concert with industry standards.
  • Documenting QA procedures (SOPs), elements of the QMS framework, describing quality procedures and also QA procedures for preventing falsified medicines from entering the supply chain.
  • Developing the Pharmaceutical Management System framework required to manage quality across the supply chain, as per ICH Q10.
  • Developing laboratory quality, analytical methods, methods validations, and product component specifications.
  • We will create program to meet current FDA expectations for cGMP Compliance within defined timeline.
  • Our team of experts provide corporate oversight programs and enhancement —including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members.
  • Assessing and qualifying your contractors, vendors and third parties through auditing, using the principles for Risk Management as per ICH Q9 and as part of periodic reassessment of your contractors and vendors as per your vendor management programme.
  • Our consultant will sit with you to design your Quality/Technical Agreements with your contractors, vendors and third parties, to include assigning roles and responsibilities for Quality Assurance to both parties this include monitoring QA metrics reported for your contractors, vendors and third parties and presenting to your Quality and Supply Chain functions.
  • Implementing site oversight programs, including internal audits and performance metrics.
  • Reviewing and enhancing management controls.
  • Reviewing and enhancing organizational structures —including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality unit.