Expertise
Quality Systems & cGMP
A quality system either supports the way your organization actually works, or it becomes a source of deviations. We help regulated companies build cGMP quality systems that satisfy regulatory expectations and remain practical enough for employees to follow every day.
Where we help
Our consultants have assessed, rebuilt and remediated quality systems across pharmaceutical, biologics, device and laboratory operations. Work typically begins with an honest assessment of the current system against applicable cGMP requirements and against how the system is actually used on the floor.
- Quality system gap assessments against 21 CFR Parts 210/211, Part 820/QMSR and ICH Q9/Q10 expectations
- Quality manual, policy and procedure architecture that reduces document count without losing control
- Change control, document control and record management systems
- Management review, quality metrics and governance structures
- Product quality reviews and annual product review programs
- Quality agreements and quality oversight of contract operations
- Quality system remediation planning, execution and effectiveness verification
Complexity is not compliance
Many organizations are cited not because their procedures are too weak, but because their procedures promise more than anyone can reliably perform. We look for the commitments a quality system does not need to make, and we rewrite the ones it does need so they are unambiguous, trainable and verifiable.
The result is a system that holds up under regulatory scrutiny because it is genuinely being followed.
Typical engagements
- A development-stage company standing up its first cGMP quality system ahead of clinical or commercial manufacturing
- An established manufacturer consolidating quality systems after an acquisition or site transfer
- A site executing a comprehensive quality system remediation with defined milestones and effectiveness checks
- A quality organization that needs experienced, temporary senior capacity
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.