Quality A Quality Management System (QMS) is the framework that helps life sciences organizations consistently deliver safe, compliant, and reliable outcomes—whether you’re manufacturing, testing, developing, or scaling operations. In biotech, pharmaceuticals, medical devices, natural health products/dietary supplements and regulated laboratories, a QMS connects how work should be done (policies, SOPs, specifications) to proof that it was done correctly (records, data integrity, training evidence, traceability). This is what turns quality from “best effort” into a repeatable operating model.
A strong QMS also reduces business risk. It supports GMP compliance, enables faster and safer growth, improves inspection readiness, and builds trust with partners, investors, and customers. When your QMS is right-sized and practical, teams move faster with fewer errors, fewer surprises, and clearer decision-making—because quality becomes embedded in daily operations, not added at the end.
What a QMS includes
A modern QMS typically covers: document control, training and competency, deviations and investigations, CAPA, change control, risk management, supplier quality, validation/qualification, data integrity, complaint handling (as applicable), and management review.
problems we solve
Gap Analysis
When quality issues show up, they rarely come from a single missing SOP. They come from misalignment between your intended controls (policies, procedures, specifications) and what’s actually happening day-to-day with records, behaviors, decision-making. A strong gap analysis makes that visible. It identifies where your QMS is incomplete, inconsistent, or not working as designed—and it separates “nice to have” improvements from issues that create real compliance or business risk.
Many customer come to us wishing to seek a new accreditation for their existing business such as ISO, Good Manufacturing Practices or Good Laboratory Practices. A gap analysis can help identify the gaps between the current QMS and where it needs to be for the desired accreditation. Others have a new build they are planning from scratch and need a QMS designed to support its operations.
We run pragmatic, risk-based gap assessments that look at both documentation and execution. That means reviewing your procedures, templates, and quality records, but also talking to the people who use them and tracing workflows end-to-end. The result is a prioritized remediation plan you can actually deliver: clear actions, owners, timelines, and a rationale that holds up in audits and due diligence.
Audit Preparation
Audits and inspections aren’t only about having procedures—they’re about having evidence. Even strong teams get caught off guard when records are hard to retrieve, training is incomplete, deviations lack rationale, or change control doesn’t show traceability. In regulated environments, confidence is built through consistency: clear processes, clean records, and staff who can explain the system accurately.
We help you prepare for GMP/GLP/ISO audits, supplier audits, client audits, and regulatory inspections by strengthening what auditors actually test. That includes focused reviews of high-risk systems, targeted record sampling, and cleanup of the most common audit vulnerabilities. We also coach teams on audit interviews and document requests, helping you present a clear, truthful, and consistent story that aligns your operations with your QMS.
Validation
Validation is where QMS meets technical reality. Whether it’s equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, computerized system validation (CSV), method validation, or utility qualification, the goal is the same: demonstrate that systems perform as intended, consistently, under defined conditions. Without a strong validation approach, organizations either create “paper validation” that doesn’t stand up to scrutiny, or overly complex protocols that slow down operations and become impossible to maintain.
We design and execute risk-based validation programs that are practical, compliant, and scalable. That starts with clear user requirements, a defensible rationale, and right-sized documentation aligned to your stage and risk profile. We then support execution—user requirement specifications, protocols, traceability, deviation handling, and final reporting—so your validation packages are audit-ready and maintainable through change control as your operation evolves.
our approach
Build a right-sized QMS: aligned to your product, stage, and risk without overengineering.
Audit-ready fundamentals: Strong document control, training, deviations/CAPA, change control, supplier quality, and management review.
Execution-first design: Procedures that reflect how work actually happens, improving adoption and consistency.
Governance and metrics: Simple quality KPIs and reviews that make performance visible and actionable.
Long-term sustainability: Templates, training, and coaching so your team can run the system confidently after we’re done.
FAQs
What is a Quality Management System (QMS) in life sciences?
A QMS is the set of policies, procedures, records, and governance processes that ensure work is performed consistently, compliantly, and with traceable evidence. In regulated life sciences, it connects SOPs and requirements to real execution through training, documentation, investigations, change control, and management oversight.
What are the core elements of a GMP-ready QMS?
Most GMP-ready QMS programs include document control, training and competency, deviations and investigations, CAPA, change control, supplier quality, risk management, validation/qualification, data integrity controls, and management review. The exact scope depends on your product type, stage, and risk profile.
What is a QMS gap analysis and when do you need one?
A QMS gap analysis compares your current quality system to applicable expectations (GMP, client requirements, internal standards) and identifies missing or weak controls. It’s useful when launching a new operation, preparing for an audit, scaling quickly, integrating acquisitions, or seeing repeated quality issues.
How long does it take to implement a QMS?
Timelines vary, but a usable, right-sized QMS can often be established in phases—starting with high-impact foundations like document control, training, deviations/CAPA, and change control. The fastest path is prioritizing what is required for your current operations and audit risk, then expanding as you scale.
What’s the difference between QA and a QMS?
QA (Quality Assurance) is typically the function or team responsible for oversight and compliance. A QMS is the system the entire organization uses to control quality—processes, documents, records, and governance—so quality is built into operations, not inspected in at the end.
How do you prepare for a GMP audit or client audit?
Audit preparation focuses on evidence and consistency: ensuring procedures match current practice, records are complete and retrievable, investigations and CAPAs are well-rationalized, and change control is traceable. It also includes staff readiness for interviews and document requests.
What does “inspection readiness” actually mean?
Inspection readiness means you can demonstrate control at any time—clear processes, clean records, effective training, and a team that can accurately explain how the system works. It’s less about last-minute cleanup and more about building a steady-state operating rhythm. In many markets, such as pharmaceuticals, medical devices, in-vitro diagnostics and lab testing, companies need to be ready for the potential of a surprise, unannounced audit from the regulators at any time.
What types of validation can a QMS cover?
A QMS can govern equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, computerized system validation (CSV), method validation/verification, and utility qualification. The QMS ensures validation work is planned, executed, documented, reviewed, and maintained through change control.
Why do life sciences companies implement QMS systems?
A QMS will help govern equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, computerized system validation (CSV), method validation/verification, and utility qualification. The QMS ensures validation work is planned, executed, documented, reviewed, and maintained through change control. In most regulated life sciences environments, a QMS needs to be planned for continuously, as early as possible.
Ready to Build a QMS That Actually Works?
Whether you’re establishing your first quality system, preparing for an audit, or closing gaps in your current QMS, we help you build practical, inspection-ready quality operations. Contact us to discuss your quality goals.
Terraforme Biosciences 