How We Help Our Clients
- Quality Engineering
- Deviation and Complaints Investigations
- CAPA, Change Control, and Technical Writing
- Method Validation, Sterility Assurance, and Microbiology
- QMS Gap Assessments
- Program/Project Management
- Operational Excellence
- Technology Transfer
- Quality 4.0: Getting Started
- Quality 4.0: Predictive Analytics & AI
- Quality 4.0: Our Solutions
- Predictive Quality Investigations App
- Continuous QMS Health Monitoring App
Key Topics
- Policies & SOPs
- Alignment between corporate, sites and regulatory authorities
- Redesign & optimization for sustainability and scalability
- CAPA Change Control
- Document Review
- GMP Training
- Quality Control
- Culture assessment and execution of change plan
- Organization Design
- Validation
- Site assessments & audit (internal and 3rd Party)
- PAIs
- Due Diligence
- Qualification
Case Study
QMS Harmonization
Opportunity…
After a significant acquisition by a global Biopharmaceutical company, the client requested a turnkey approach to harmonize R&D quality standards and SOPs at the acquired sites, with corporate standards. Acquired sites to be harmonized were located on three continents: Europe, Asia, and South America.
Approach…
- OQSIE structured the approach and resource plan.
- Conducted a gap assessment of current site SOPs.
- Prioritized gaps identified at the site level to manage “red, yellow, green” findings and avoid potential regulatory actions.
- Implementation activities included revision of SOPs, and managing the revisions through the client change process to final approval and implementation.
- Our Project Managers developed plans and drove harmonization activities at the various sites.
- Our Subject Matter Experts on quality systems and aseptic manufacturing supported the revision and implementation of SOPs.
- Our QPs helped to upskill local Quality leaders in batch disposition / release requirements.
Outcome…
The QMS Harmonization initiative was completed on-time & on-budget.
Case Study
Quality Culture Assessment
Opportunity…
A global Biopharmaceutical client requested a Quality Culture Assessment of its global vaccine franchise with sites in the U.S. and Europe.
Approach…
- OQSIE structured the approach and resource plan.
- A team of cross functional experts conducted the assessment, with expertise in human resources, regulatory, vaccine manufacturing and project management.
- A single team was utilized to ensure consistency of approach at the five sites assessed.
- Deployed multiple data gathering approaches, e.g., one-on-one interviews and group polling sessions.
- Participants ranged from corporate and site leadership to shop floor supervisors and operators.
- All information was kept confidential to facilitate open communication and input from all involved.
- Findings were presented to the client’s sponsor group.
- We facilitated the go-forward planning session with the leadership team, and delivered a short, mid, and long-term execution plans.
Outcome…
The assessment was executed on-time and on-budget. Our client implemented the plans we jointly developed, and reported extraordinary improvements in operational performance.
Project examples
For a global client, a Senior Project Manager developed and led execution of the initiative to expand their Quality Management System to integrate requirements for combination products.
Provided ex-FDA experts in GCP & BIMO for a global Biologics client to perform a gap assessment and lead remediation activity ahead of their PAI.
A Subject Matter Expert (SME) audited the Quality System of a pharmaceutical client’s transportation system.
Provided four Subject Matter Experts to develop the Quality Management System for a new aseptic manufacturing and packaging facility start-up.
Provided two cGMP training experts to develop and deliver training program for 170 new employees.
One SME developed and implemented the Supplier Quality Management program for a pharmaceutical client.
Two SMEs supported start-up of secondary packaging operation, developed SOPs for equipment validation and operational activities.
One SME oversaw SOP development for warehouse / distribution center operation.
One SME redesigned the global change control system for a large generics manufacturer.
**examples listed are representative, not an exhaustive list of projects OQSIE has supported**