SERVICES WE OFFER

We offer companies cost efficient solutions to today’s growing concerns. 

 

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Clean Rooms and Manufacturing

Our customers include manufacturing, research, public health and consultancy organisations. Our experience enables us to offer a very broad range of skills. We can provide a fresh look at customers’ requirements as well as providing well thought out solutions based on knowledge and experience.

 

Our expertise include:

 

  • Cleanroom design & specification for research, manufacturing and processing.
  • Aseptic manufacturing (pharmaceuticals, devices, hospital pharmacies & radio pharmacies, etc )
  • Medical device and equipment design and procurement.
  • Specialist laboratory design. Over the past 15 years our responsibilities have included the Managing and installation of over 50 clean facilities, including ground breaking research (stem cell etc) and manufacturing units. Many of the units have been for aseptic processing of pharmaceuticals and biological products at manufacturing, research and hospital facilities in the UK and abroad.
  • Installations have also included secure server rooms and cold rooms as well as Nuclear facilities in the UK and a microprocessor facility for a space agency in India.
  • Liaising between Client and main contractor and local authorities to solve and satisfy any issues that may arise. Also handling the logistic element of the installation.
IQ, OQ, PQ

Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part of quality assurance through equipment validation.

We can work with the project teams to ensure that new equipment is first validated to make sure that it is capable of producing the desired results through Design Qualification (DQ).  We create the documentation and work with your staff to test the equipment’s performance.  Installation Qualification (IQ) verifies that the instrument or equipment being qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and configured in accordance with the manufacturer’s specifications or installation checklist.

In addition to this, any cGMP requirements that pertain to the IQ and the approach used for IQ is thoroughly-documented in the Validation Master Plan (VMP) which we can create.

Process Streamlining

A business process is a set of steps or tasks that you and your team use repeatedly to create a product or service, reach a specific goal, or provide value to a customer or supplier. When processes work well, they can significantly improve efficiency, productivity, and customer satisfaction.

However, processes that don’t work can cause frustration, delays, and financial loss.

To improve a business process, we focus on the following.

  • Map processes.
  • Analyze the process.
  • Redesign the process.
  • Acquire resources.
  • Implement and communicate change.
  • Review the process.

Keep in mind that you’ll need to improve most processes at some point. New goals, new technology, and changes in the business environment can all cause established processes to become inefficient or outdated.

Corrective Action Preventative Action (CAPA) Development

We work with companies to better develop their CAPA systems.  The purpose of CAPAs are to:

 

  • To collect and analyze information to identify actual and potential product and quality problems
  • To investigate product and quality problems and take appropriate and effective corrective or preventive action
  • To verify or validate the effectiveness of corrective and preventive actions
  • We help companies to understand the importance of communicating corrective and preventive actions to the appropriate people. How to present the information (tracking, trending and effectiveness) and why it is important to provide information for management review
Standard Operating Procedure (SOP) Development

Square One Priorities knows that the only way to create useful, lasting SOPs is to work with the client and to understand their operations.  The process that we follow is the following:

 

  1. Planning: Think about the steps that are currently done to complete the process. How is it done? Why is it done that way? How will an SOP improve the process? How will you measure performance?
  2. First Draft: Make a detailed list of the steps in the order that they are done. This list is now a draft of the procedure.
  3. Internal Review: Get input from all workers who now perform the procedure. Give them your first draft but make sure they know that it will still change. Revise the procedure as necessary.
  4. External Review: Involve your technical advisors. Revise the procedure as necessary.
  5. Testing: Validate the procedure by doing each step exactly as it says. Have a person not familiar with the work follow the procedure. Revise as necessary.
  6. Posting: Make a final draft of the procedure, approve it and post in the workplace.
  7. Training: Train or re-train everyone as necessary to follow the procedure exactly.
Quality Control
QC is that part of quality management focused on fulfilling quality requirements.  We can help you with the design and implementation of an effective QC program. How do we do this?  We work with your Quality staff and Operations to determine the extent of QC program. Next, real-world data is collected and the results reported to management personnel. After this, a corrective action (CAPA) must be decided upon, if warranted and taken. We can help you to create a plan, which is designed to improve the production or service process and put that plan into action. The QC process must be ongoing to ensure that remedial efforts, if required, have produced satisfactory results and to immediately detect recurrences or new instances of trouble (tracking, tending and evaluating effectiveness).
Internal and External Audits

An internal audit is performed within an organization to measure its strengths and weaknesses against its own procedures or methods and/or against external standards adopted by (voluntary) or imposed on (mandatory) the organization. An internal audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited.

An external audit is performed by an audit organization independent of the customer-supplier relationship and is free of any conflict of interest. Independence of the audit organization is a key component of a third-party audit. An external audit may result in certification, registration,

Quality Assurance
We work with your Quality team to reinforce and/or develop a robust QA program.  QA consists of that part of quality management focused on providing confidence that quality requirements will be fulfilled. The confidence provided by QA is not only focused externally on customers, government agencies and regulators, but also internally to management.  A strong QA program can support both the present and future growth of a company
Facility Design
Laboratory facilities have architectural, space planning, HVAC, environmental control, and fire/life safety requirements not found in most other types of construction. Sound laboratory facility design standards, construction documents standards, and equipment standards in the hands on qualified engineers and contractors are the foundation on which successful laboratories are built. Sound operating guidelines in the hands and hearts of skilled facility operators and laboratory personnel are the tools that will keep the facility operating smoothly and efficiently. Square One Priorities has the expertise to write these design documents.
Technical Writing
We can create regulatory compliant SOPs and validations that are designed to work with your operations.  We can design training programs and forms in support of your SOPs.  Our team of experts can also work with your staff to help you to streamline your policies, processes and procedures, which in turn create a higher level of efficiencies, potential realization of cost reductions and enhanced overall flow.
Project Management

Knowledge, experience, skills, tools and techniques are essential to successfully meet the requirements of a particular project. We tackle projects in 5 phases:

  1. Project conception and initiation

We can help the company to determine whether or not the project benefits the organization. During this phase, we work with a decision-making project team to identify if the project can realistically be completed in such a way as to meet the timelines, needs and goals of the company.

  1. Project definition and planning

A project plan or project scope may be put in writing, outlining the work to be performed. During this phase, we help the project team to prioritize the project, calculate a budget and schedule, and determine what resources are needed.

  1. Project launch or execution

Resources’ tasks are distributed and teams are informed of responsibilities.

  1. Project performance and control

We arrange weekly meetings with project managers and compare project status and progress to the actual plan.

  1. Project close

After project tasks are completed and the company has approved the outcome, an evaluation is performed.

GOT QUESTIONS ABOUT OUR SERVICES? CONTACT A CONSULTANT TODAY

Whether you need immediate assistance or are looking for an overall operational assessment, Square One Priorities is here to help you achieve your business goals.