Focused Assessment

Audit Capabilities

APEX Performance Excellence Group audit service capabilities include providing effective global quality auditing services across medical devices, pharmaceutical, biotechnology and combination product industries. Our auditor pool is diverse, highly skilled, certified, and includes a wide range of expertise. We specialize in providing holistic auditing services ranging from early-stage development to post-market surveillance after product launch. These services include but are not limited to:

Countries/Regulations/Standards accommodated include (FDA, MHRA, EMEA, EMA, TGA, ANVISA, Health Canada, Japan Ministry of Health) and others.

Auditing Certification Agencies include (EXEMPLAR GLOBAL, CQA, ASQ, BSI, INTERTEX, MDSAP, ORIEL-STAT, TUV, UL, ISO)

Dual Function Audit Offering

Take advantage of this unique strategy to qualify members of your team while completing your annual internal audits. Build your teams bench strengths by adding additional skill sets.

Benefit:

• Certify your own staff to be qualified to perform internal and/or external audits.
• Complete your internal audits quickly while meeting quality requirements.

How:

Step 1- Identified staff members attend training (On-site or remote)

• 16 Hours (can be modified into ½ day sessions) covering 20-30 lecture topics.

Classes can be customized to meet organizational needs.

• Additional targeted modules can be added at the client’s request (2.5 hours at a minimum)

Step 2 – Shadow Qualification (On-site and remote)

• Identified staff members will work with APEX auditors to conduct the company’s internal or external audits.
• A program can be customized to meet client-specific needs.

Auditing Certification:

• APEX Certificate of Completion will be offered (attesting to attendees mastering skills as demonstrated by competency assessment).
• APEX Internal Lead Auditor Certification (after successfully completing three audits under the direction of an APEX Lead Auditor).
• Potential C.E.U.(Continuing Education Units) depending on course selection and content.

Post-Audit Support

APEX can support execution of audit observation closure to resolution using our proven methodologies, approaches, subject matter expertise, and tools.

Click here to learn more.

Assessment Capabilities

Whether you need to prepare your organization for the next level of growth and success, bring your quality system into compliance, drive a small-focused effort to improve a process, or bring in valuable subject experts, APEX has the knowledge, experience, and resources to support your business in its pursuits. The first step in APEX “meeting the organization where it’s at in its journey”, is to evaluate or assess the organization as related to:

Potential for Growth

• Process-focused positioning of an organization for growth beyond current capabilities and management practices.
• Development and application of a business model as framework for a holistic approach of managing the organization.
• Process architecture development around organizational key value stream(s) (key product or service).
• Aligning vision/mission to process metrics and actionable improvement opportunities meeting requirements.
• Creating a Culture of Fact-Based Process Execution
• Deep and Broad process understanding to gain rich insight into problems and solutions, based on facts not opinions.
• Alignment of Demand Requirements, TAKT time, current process performance and efficiency to determine KPI Goals for Monitoring, Process Capacity, and Improvement Opportunities.
• Providing insight into how much improvement organizations NEED, vs how much they can get.

Ability of the Organization and the Quality Management System to meet Regulatory Requirements

• Operationalizing requirements into well-defined, executable processes that can be measured and improved.
• Multi-tier documentation structuring (architecture) providing for policy-setting and “floor” execution.
• Quality Manual development meeting ISO standards, yet tailored for specific organizational needs and Quality philosophy.
• Timely Regulatory Remediation and Execution
• Translating audit findings/observations into actionable process-focused resolution.
• Product knowledge translated into Critical to Safety/Quality attributes in a compliant Design History File.
• Process development integrating foundational documentation practices, process controls, and Lean/Six Sigma tools.

Availability of Resources and Team Management

• Individual subject matter expert contribution for a focused effort
• Team leadership/project management for a focused work group to achieve specific goals or deliverables.