Targeted Initiatives

In our experience, process development and management are the keys to successful outcomes, whether they be implementing growth strategies, recovering from adverse regulatory compliance findings, or using techniques to eliminate waste and improve efficiency.

APEX can meet you at any point in your excellence journey, be it bringing a single process into compliance, identifying bottlenecks in several manufacturing processes, or holistic and comprehensive management system development.

“Our passion is to improve, remediate, or design business and quality systems with a focus on process.”

APEX partners with leaders in developing management systems (QMS, R&D, Operations, Supplier, Business, etc.) to execute their strategies. These systems are the collection of, processes, people and practices that deliver the products and services of an organization.

Benefits of a well-defined Management System:

• Positions an organization for growth.
  Instead of reacting to daily issues, you are “wanting more work”.
• Designed to be compliant.
  A good Management System addresses the how while remaining faithful to the what.
• Creates an opportunity to engage the workforce and transfer knowledge.
  Employees at all levels of the organization have visibility to top management direction, through actionable, reliable metrics along with management practices that foster engagement and satisfaction.

“We believe the keys to organizational success are the ability to execute and manage compliant processes, not just to pass an audit.”

Transforming an Organization

APEX’s approach to implementing or transforming (current to future state) Management Systems is defined in our Organizational Excellence Model™, the “Atomic Model™”. The model is made up of seven elements that are based on well-established and proven “excellence” criteria. However, the model is designed and intended to be adapted or modified by an organization’s leadership team through a series of facilitated work sessions to meet the organization’s specific and unique requirements.

The “Atomic Model™” helps an organization drive alignment and execution around fundamental elements required in the successful execution of an operation highlighted by the following:

• Leadership sets strategic direction through planning around a vision and mission.
• Processes, informed by regulations and standards (requirements), are then designed or improved with workforce engagement and involvement, to build and nurture a high-performance work culture.
• Operating mechanisms are created to collect, analyze, and report data to afford management with the ability to drive results and continuously improve.

Creating a Sustainable Foundation

Transformation is holistic and comprehensive. It takes time and patience to develop and nurture an organization’s journey to full fruition. We recognize the urgency and importance of gaining fast results in key areas.

To that end, our “Target Model™”, a subset of the “Atomic Model™”, drives immediate improvement opportunities to gain traction in a transformative effort.

This focused approach is intended to build foundational process attributes and management practices for repeatable and sustainable results.

Product / Quality System Remediation

Many companies struggle bringing their products into compliance following a regulatory action (e.g. FDA-483, Warning Letter, etc.). Oftentimes, device design files (and their associated requirements) are very dated, leading to ambiguity in decision-making and clarity as to a path forward. Pharmaceutical batch records may be incomplete, inaccurate, or designed poorly, promoting documentation errors.

APEX has developed process-focused approaches to Remediation with specific methods:

• Using development tools to define and implement new processes within the quality management system. Procedures must meet current requirements and be effectively executed.
• Deconstructing existing designs into fundamental requirements and risk controls, identifying missing elements and gaps, and engaging cross-functional product development teams in developing appropriate design inputs, outputs, and risk controls.
• Developing defensible, risk-based acceptance criteria for use in verification/validation activities and QC inspections.
• Assisting with writing protocols, quality plans, CAPAs, etc. to show evidence of progress and results as you move through remediation.

Whether it’s top-down QMS documentation from a quality manual down to a work instruction, APEX brings its expertise and experience to bear, helping you achieve your compliance goals.

“Our differentiator is implementing compliant processes that are designed to be effective and efficient as well.”

Increasing Capability and Knowledge

APEX can provide timely, experienced resources to fill short-term gaps in process execution and help organizations “get caught up”. Whether it’s bringing aging CAPAs to closure before an anticipated audit or updating large numbers of supplier files to meet current requirements, we roll up our sleeves and work alongside your teams to complete their projects.

An important characteristic of our highly experienced team members is their ability to engage the organization and transfer knowledge to less experienced resources, thereby building a more effective organization.

“We leverage highly experienced team members that bring subject matter expertise in resolving specific issues.”