Building a Voluntary QA Culture

Quality is about what We Must Do ... not what You Can’t Do.

Lab 01Through education and training, accountability and collaboration, CQS works to ensure every employee understands their value and role in a “Voluntary QA Culture.” CQS helps people deliberate on Quality proactively so they spend less time in reactive mode.

When Quality operates as a policing body or in a punitive manner, it disengages people at all levels of the organization, preventing them from taking ownership. When people disengage, they do not participate and are not encouraged to find ways to improve processes and innovate.

Putting the “Why” in Quality

Researcher 01But when people are educated, trained, and understand the “Why,” they are more likely to be more engaged and build a culture with higher levels of accountability and personal commitment.

CQS Founder Judy Carmody, Ph.D., believes Quality must be a core strategic value rather than an outlying task. This approach allows Quality systems to evolve, adapt, maintain strength, and increase value and performance. By building “Voluntary QA Cultures,” Dr. Carmody better equips clients to focus on sustained collaboration, transparency, performance and innovation. CQS is driven by the 4 Cores of a Voluntary QA Culture, which underlie and drive our efforts and our commitment to see our work through to your satisfaction.

Our Service Groups are:

Management Services

  • Strategic Planning and Organizational Change Management
  • Development, Implementation and Management of Quality Plan
  • Development, Implementation and Management of Inspection Readiness Plan
  • Process Harmonization and Efficiency Improvements

Quality Assurance Services

  • Building Quality Systems
  • SOP Writing and Review
  • Quality Manual/Policy Generation and Review
  • Internal/External Auditing
  • Mock Audits
  • Creation of Training Programs
  • Training of Personnel
  • Batch Record Review/Release
  • Gap Assessments
  • Vendor Selection and Qualification
  • Vendor Oversight and Management
  • Documentation/Review and Resolution of Event Investigations, CAPAs, Deviations, RCAs and OOSs
  • Regulatory Submission Review
  • Quality Metric Program
  • Supply Chain Oversight
  • Change Control
  • Quality Management Review Process
  • Risk Management Programs

Quality Control Services

  • Method Transfer
  • Method Validation
  • Computerized System Qualification
  • Transfer/Validation Protocol and Report Generation/Review
  • Equipment Program Creation, including Receipt, Classification, Qualification, Maintenance and Tracking
  • Troubleshooting
  • Data Review
  • Stability Program Creation
  • Stability Protocols
  • Reference Standard Programs
  • Complaints Programs
  • Justification of Specifications and Specifications
  • Cleaning Validation

IT Network Infrastructure Qualification Services 

Maintaining IT Infrastructure and Software in a Demonstrable State of Regulatory Compliance. Protecting Integrity, Security and Availability of Data Generated by Validated Computerized Systems. Developing Materials for Specific Systems at the Same Level of Quality Required by other GxP-Validated Systems

  • Creating, Reviewing and Managing Documentation for Applications in FDA- and HIPAA-Regulated Environments, including 21 CFR Part 11
  • Creating, Reviewing and Managing Documentation to Qualify Network Infrastructures under Good Automated Manufacturing Practice (GAMP5) Guidelines
  • Producing Customized Documentation for Required QA Standards (Qualification Master Plan, Risk Assessment Matrix, Detailed System Description and Logical Model Diagram, System Requirement Specifications, Detailed Component Inventory, Functional and Technical Specifications and Highly Customized IQ/OQ Test Scripts)
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