Be it Pharmaceutical Bio Medical or Medical Devices , Quality Control and Assurance face internal financial pressures, and the use of outside vendors, makes the need for ultimate quality, and increasingly complex and demanding regulatory requirements all present impediments to getting products to market.
Quality validation, in addition, the need for extensive validation slows the ability to adopt new process-related technologies commonplace in other industries but not so in life science firms.
Our staff individually have over 20 years’ experience as quality leads, assurance managers, certified auditors through ASQ, interfacing with the FDA, ISO notified bodies and global vendors to enforce quality management systems.
They have extensive backgrounds with :
- ISO 9000 , 9001/13485 for Global Marketplaces
- MDD 93/42
- CE marking
- CFR Part 11
- Total Quality Management (TQM)
- GxP Part 11
- Agile Quality Methodology
- LIMS Maturity Assessment
- Process Re-engineering
- Product evaluation and roadmap
- Document Management
- Deviation/ Non-Conformance
- Quality & Regulatory Management
- Safety Assurance & Compliance
- Submission-Ready Documentation
- 510k, PMA, IDE, eMDR ,FDA 820etc.
- Product Registration
- Submission Management
- all QMS regimes
Our Quality Service Area Expertise include:
- Computer System Validation (CSV): Computer Systems Validation (CSV) is a quality management system most commonly used across the pharmaceutical industry for the purpose of assuring that requirements are consistently fulfilled. CSV will assure the reliability of the software and system as it pertains to SISPQ – Safety, Integrity, Strength, Purity and Quality of a product. Why is this? Computer systems and software are used to control measure and monitor the manufacture, distribution and sales of pharmaceuticals.
- CFR Part 11: Or Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
- Infrastructure Qualification: Qualification is the documented process that any component of the infrastructure works correctly and as per expected results.
- Test Management: The process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected and actual results. Testing is fundamental to providing assurance that the software, technology and infrastructure works as expected to meet the requirements. Validation and Qualification cannot be performed without testing.
- Deviation Management: Deviation handling plays a key role in assuring quality in products and contributing to continuous improvement. A clearly defined Corrective Action and Preventive Action (CAPA) program can streamline deviation handling. Once a deviation is detected, it needs to be contained with immediate actions (i.e., corrective), the root causes identified as necessary, and systemic actions implemented (i.e., corrective preventive actions) as applicable in order to prevent in the future, the same or similar non conformances.
ISO 9000 Compliance
ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), that define, establish, and maintain an effective quality assurance system for manufacturing and service industries.
ISO 9000 is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based.
- Principle 1 – Customer focus
- Principle 2 – Leadership
- Principle 3 – Involvement of people
- Principle 4 – Process approach
- Principle 5 – System approach to management
- Principle 6 – Continual improvement
- Principle 7 – Factual approach to decision making
- Principle 8 – Mutually beneficial supplier relationships
Implementation of ISO 9000 will affect the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.
Quality Audit & Assessment
In any activity to determine, directly or indirectly, that a process, product, or service meets
The Pharmaceutical Industry is subject to a number of compliance assessments:
- Maturity Assessments: It is important to understand where you are on Compliance Maturity so you can determine what actions to take to create value for your business from your GRC (Governance, Risk Management, Compliance) solution.
- Vendor Assessments: Companies leverage the expertise of software, infrastructure, and service providers as an alternative to building equivalent capabilities in-house. Outsourcing and partnerships with external service organizations, cloud infrastructure providers, and software vendors have become strategic initiatives in most organizations’ plans. Therefore a vendor assessment is the vehicle most often used to inspect and evaluate a vendor’s quality management system, practices, and documentation. The need to conduct such assessments, or audits, and inspect a vendor’s quality practices has been recognized by the industry for several years now.
- Assessment of SOX Controls: Ensure your accounting operations are in compliance with the Sarbanes Oxley Act.
- GxP Part 11 Assessment: The international legislation in GxP constantly changes. Remain up to date on current regulations and directives and have a clear overview as to whether or not you comply with the current regulations. Inspectors will be interested in the evidence relating to the firm’s assessment of the supplier’s critical automated features aswell as the traditional engineering, qualification and process performance aspects.
- Audits: Our certified Auditors provide guidance using quality audit systems (QMS) and IT which is important because it gives assurance that the IT systems are adequately protected, provide reliable information to users and properly managed to achieve their intended benefits. IT audit could also help to reduce risks of data tampering, data loss or leakage, service disruption, and poor management of IT systems.
Quality Program Management
Program management is about managing groups of projects to achieve a desired outcome or benefit for an organization. It is about the structuring and control of those projects so they deliver effectively as a group.
GRC Tool Implementation
Based on a Gap Analysis we can give guidance on implementing a GRC Tool for continuous and sustainable Service Improvement.
- A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management.
- Of all QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide
- Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.
All of our Project Managers are highly experienced and are PMI and Prince 2 certified. We have lead projects in the pharma, banking sectors and across technologies such as cloud services, mobile infrastructure, operating systems, application distribution, data center building and upgrades. Projects we have managed range in size up to multi-year multimillion dollar organizational change programs. We can manage not only the technological aspects of your projects but can also advise on operational integration, training and communication. Our project managers have set up and lead Program Management Offices and executed all processes involved.
Quality Management and Validation
- Moving from the established concepts of quality control and quality assurance to quality management. The concept of Total Quality Management (TQM) is a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback. It includes creating and implementing quality planning and assurance, as well as quality control and quality improvement.
- Validation, in addition, the need for extensive validation slows the ability to adopt new process-related technologies commonplace in other industries. Internal or Vendor Pilothouse Advisors can Validate QA and QC systems and processes to achieve ridged compliance standards.
Training in Quality Control, Assurance and Audit
Often, changing technologies and processes involves fundamentally changing the way that people work. We can help you to create and execute training plans for end-users as well as supporters and technicians to ensure the success of any change. Our trainers are equally comfortable with traditional classroom training, online classroom delivery, creating eLearning materials or utilizing social media and on-demand learning methodologies. Additionally, we can design on-boarding programs for new project managers, quality managers or other quality staff in your organization, ensuring that new hires are productive as soon as possible.
We would welcome an opportunity to discuss how the cadre of experience, skills, and tools we bring to the table can best serve your needs.
Contact an Advisor for your complementary no-obligation discovery session.