Quality systems and QMS consulting for life sciences
Quality systems consulting is the design, repair and digitization of a pharmaceutical quality system so that it meets 21 CFR Parts 210/211, Part 820 and ICH Q10 and fits the way the site runs. QLogixCMC assesses the system you have, designs or remediates the processes and procedures, and, where you choose, moves them onto a validated electronic QMS.
What we assess and design
The core quality processes, written as connected workflows rather than separate forms, so a deviation can open a CAPA, a CAPA can open a change control, and each record links back to the evidence behind it.
- Deviations and investigations
- CAPA, with effectiveness checks
- Change control
- Complaints and recalls
- Document control and training
- Supplier qualification and quality agreements
- Management review and quality metrics
- Annual product review (APR/PQR)
How the work runs
We start with a gap assessment against the regulations that apply to your products and the procedures you already have, and agree baseline measures such as deviation cycle time and backlog age before anything changes. The assessment decides the order of work: which processes are rewritten first, which need remediation, and which records have to be migrated.
Procedures are drafted with the people who will follow them, piloted on live records, and released through your document control with the training that goes with them. Where the site moves to an electronic QMS, selection, configuration, data migration and validation run together with the SOP updates, so the system goes live with procedures that describe how it is used.
Electronic QMS: the one you choose
Where a site moves to an electronic QMS, we help select the product against your requirements, then configure, migrate to and validate it. The advice does not depend on the vendor: the recommendation follows your processes, your records and your budget, and the same engineers implement whichever eQMS the site chooses.
- Requirements and selection, with a scored comparison of the candidates
- Configuration to your SOPs, not the vendor's template
- Migration of the records you have to keep, verified against the source
- Risk-based validation following GAMP 5 (Second Edition)
Questions about quality systems and QMS
Do we have to replace our current QMS?
Not necessarily. QLogixCMC starts with a gap assessment of the processes and the system you have. Where the procedures are the problem, the fix is procedural. Where the system itself is holding the site back, we help you select, implement and validate an electronic QMS that fits your processes and your budget.
How long does a gap assessment take?
A gap assessment of a single site's quality system usually takes two to four weeks of QLogixCMC time, depending on the number of processes in scope and how much of the documentation is available before the site visit. It ends with a prioritized remediation plan and agreed baseline measures.
Can you write our SOPs?
Yes. QLogixCMC drafts procedures with the people who will follow them, so they describe the process as it will actually run. Your quality unit reviews and approves every procedure before it is released through your document control.
Who is this service for?
Emerging and mid-size biotech and pharma companies building a quality system ahead of clinical or commercial manufacturing, CDMOs and CMOs aligning one system to several client quality agreements, 503B outsourcing facilities meeting cGMP expectations with lean teams, and medical device manufacturers moving to the Quality Management System Regulation (QMSR).
Related services
- CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.
- Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.
- Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.
- Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.
- GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.
- AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.