Quigley Compliance Associates

Services

A Customized Approach to Client Compliance

Areas of Expertise


Validation Life cycle

The validation life cycle is an organized, and comprehensive approach designed to assist GxP clients in the organization and execution of validation activities. The validation life cycle ensures user specifications are met while allowing companies to focus on meeting their regulatory requirements with confidence.

  • Risk/Impact Assessment
  • Process Audit
  • User Requirements Specifications
  • Validation Master Plans
  • Validation Project Management
  • Functional Specification
  • Design Specifications

Facilities and utilities

The environment in which your processes are carried out is just as important as the process itself. Ensuring environmental conditions are suitable for your needs requires attention paid to the components behind the scenes. From small, single room systems to complex facility installation, QCA can assist in all of your commissioning or qualification needs.

  • Clean Rooms
  • Warehouses/Cold Chain
  • HVAC Systems
  • Chilled / Heating Hot water
  • Gas Distribution Systems (Air, Gases)
  • Purified Water Systems
  • Building and Laboratory Mangement/Monitoring Systems

 


Process validation

When instituting a new process or up-scaling your existing one, process validation can help to identify potential variables and unexpected issues. We can help from the onset of the project by providing thorough process design review through process qualification and continued  monitoring ensuring your results are consistent between runs. Using tools to evaluate risk along with our extensive regulatory understanding, QCA can provide everything needed to ensure instituting your new process is smooth as possible.

  • Fermentation Skids
  • Clarification and Concentration Equipment
  • Purification 
  • Fill/Finish Equipment
  • Labeling and Packaging
  • Process Validation

commissioning

QCA uses a well planned, documented, and managed engineering approach from the start up of facilities, systems, and equipment to the turnover to the end-user. Commissioning includes planned and documented series of inspections, adjustments, and tests carried out systematically to ensure the installation satisfies technical operation as specified.

  • Integrated Commissioning (leverage in validation)
  • Pre-Functional Checklists
  • Functional Checklists
  • P&ID Walk Downs
  • System Redlines
  • Turn Over Packages

Project Management

Managing schedules, contractors, and customers requires a dedicated focus that can sometimes become a full time job. QCA can help you manage, or manage your project for you. QCA has the experience and tools required to see your project through from inception to completion. Offering skilled and seasoned mangers or administrative assistants and every thing in between, we can tailor management projects to fit your needs with a keen eye for details and organizational skills while maintaining your cost, quality, scope, and time requirements.

  • Project Scheduling
  • Client Integration
  • Budgets
  • Project Managers
  • Administrative Assistants
 

Facility & Equipment Documentation

Reliable and consistent quality hinges on properly functioning maintenance and operating procedures for your facility and equipment. Overlooked regular maintenance can lead to unscheduled downtime and delays in your project. Furthermore, equipment, procedures and processes are the backbone of your operational success. Creating and maintaining a robust maintenance program as well as clear operational procedures will ensure your systems and team are functioning at their highest potential.

 

  • Standard Operating Procedures
  • Preventative Maintenance Plans
  • User Requirements Specifications
  • Calibration Program Audit

controlled Temperature Units (CTU)

Controlled temperature storage units are a key part to ensuring your materials retain their quality attributes. With the large reliance on controlled storage in today's biotech industry, qualifying CTUs should be a painless exercise. Fill out this form to tell us more about your CTU validation needs.

  • Qualification Packages
  • Refrigerators (2°C to 8°C)
  • Freezers (0°C to -80°C)
  • Cryogenic Freezers (-140°C to -190°C)
  • Incubators (variety of ranges)
  • Cold Rooms
  • Stability Chambers

Validation

Validation often feels like a daunting task requiring large amounts of planning and coordination between operating groups, contractors, and customers. Over the years, QCA has worked with and witnessed many different validation approaches across the industry. This allows us to customize and tailor a validation approach that fits your schedule, budget, and regulatory needs. Standard validation disciplines include, but are not limited to the following:

  • Facilities
  • Utilities
  • Process and Analytical Equipment
  • Cleaning and Process Validation
  • Controlled Temperature Units
  • Automation
  • Computer System

Cleaning Validations

    Your process results are heavily dependent on the cleanliness of your equipment and environment. QCA can help establish safe operating limits and review cleaning agents and methods used to maintain operation within these safe limits. We can help your company generate strong cleaning procedures and institute rigorous sampling routines to ensure your equipment is cleaned properly and records are maintained. Cleaning validation can be long and tedious process, let QCA help you define your process and ensure compliance with FDA regulations.

    • Soil Library
    • Cleaning processes
    • Swab Study Execution
    • Autoclaves
    • Washers
    • Steam in Place
    • Clean in Place