Don’t Wait for “Them” to Find Your Weaknesses

Don’t Wait for “Them” to Find Your Weaknesses

Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech

We’ve probably all heard the phrase “audit ready state”. But what does it really mean?  How do you get to and maintain an audit ready state?  An audit ready state is simply operating in a way where you are ready for an audit at any time.  This may be a client audit or a regulatory audit.   

One of the best ways to get into an audit ready state is to perform internal audits and self-audits on a frequent basis.  Have different individuals and quality assurance look over operations, processes, and physically walk-down areas e.g., Gemba Walks, etc.  Take findings seriously and implement corrective and preventative actions. During self-audits look at labeling, cleanliness, expiration dating, documentation, logbooks, equipment calibrations, reagents, blocked isles, waste bastes, incubators, etc. You want to systematically look at your area of responsibility and pretend you are a regulatory auditor.  What would the auditor see?  Your goal is to find and correct potential findings.  What you find and fix are audit observations proactively dealt with.  It is better that your internal audit systems find potential observations and implement solutions than for clients or regulators to find your weaknesses.    

Tools, such as 6S (Sort, Set In Order, Shine, Standardize, Sustain, and Safety), will help to ensure that everything is clean and in place.  Frequent self-auditing and adherence to 6S principles gives you constant feedback and allows you to adjust processes where needed to ensure you are consistently audit ready.  Remember, don’t wait for “them” to find your weaknesses.

Another tip is to be in an “audit state of mind”.  This means developing the mindset to pursue top-notch quality on a daily basis and embrace the concept of continual improvement. 

Need help getting started?  PSC Biotech™ provides custom programs to help companies get to a compliant audit ready state. Experienced consultants are available to perform audits of your facility and processes to help ensure your current processes and quality systems are compliant.   

PSC Biotech™ offers a wide variety of solutions to ensure success for any size company, including consulting, risk assessment, writing standard operating procedures, protocols, and white papers, project management or complete turnkey project services to execute projects to free up your company’s valuable resources.  Whatever your needs may be, PSC Biotech™ is here to help. Give us a call today!  

Calibration and Validation in the Life Sciences Industry

Calibration and Validation in the Life Sciences Industry

Calibration and Validation are critical regulatory requirements of the Life Sciences Industry.

If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com.

FDA defines validation as “…a process that is required to establish documented evidence to assure that a specific system, equipment, computer system, or process will consistently meet the requirements and its intended use.”

All organizations need to validate their systems, computers, equipment, and processes that have GMP impact.

Calibration is the process of determining the accuracy of the measurement system over its intended range of use against the defined standards. Life science companies calibrate their instruments to measure process parameters.

  • Temperature
  • Relative Humidity
  • Pressure
  • Flow
  • Volume
  • Mass
  • Length

Are Validation and Calibration Different?

Yes.  You can’t validate unless you calibrate first!  Calibration assures the accuracy of your measurements.  Validation uses your measurements with your calibrated instruments to provide documented evidence that whatever you are validating meets your user requirements for its intended use.  Whether it is calibration or validation, PSC Biotech can meet your needs.

PSC BiotechTM Metrology is our Metrology laboratory and pharmaceutical validation service with experience and skill in serving the life science industry across the globe.  PSC Biotech Metrology provides calibration services and rents calibrated equipment to ensure that your facility stays Gap compliant.

Our Metrology Unit offers the following range of services:

Instrument Calibration Services:

  • Calibration of temperature, humidity, pressure, and mass
  • Metrology plan review and preparation
  • Field instrument calibration
  • Reference instrument calibration

Calibrated Equipment Rental Services

  • Kaye® Validators, LTRs, HTRs, SIMS
  • Lives® International Wireless Data Loggers
  • Ellabs® Wireless Data Loggers
  • Cryopack® Wireless Data Loggers
  • CLiMet® Particle Counters

PSC Biotech also provides the professional services to execute your validation program.

Validation Services

  • Reviewing and preparing for the validation master plans
  • Gap analysis and risk/impact assessments
  • Qualification and validation, including validation plans, design, installation, operational and performance qualifications
  • Support to implement remediation program
  • Equipment commissioning (factory and site acceptance tests)

Process and Quality Support

  • Third-party and supplier assessment, qualification, and auditing
  • Remediation plan management
  • Risk and gap analysis support
  • Cleaning process development and validation
  • Technology transfer support
  • Regulatory support for the preparation and upgrade of document types
  • Processes and primary packaging validation
  • Inspections and audit preparation along with annual product reviews
  • GMP support (i.e., variations and deviations management)
  • Internal processes analysis to boost the efficiency of the company

If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com

How Consulting Services Can Ease Your Pain Points

How Consulting Services Can Ease Your Pain Points

Written by: Jasmine Cho – Operations Manager, at PSC Biotech Corporation  

The biopharmaceutical industry is often on the front lines, battling global issues, such as the recent global pandemic of COVID-19. Life science companies work to provide solutions and find cures for the world, which requires constant innovation and new solutions. This can strain managing your day-to-day operations as new projects emerge and demand resources. Here are 3 ways consultants can ease your pain points.

1. Provide Subject Matter Expertise and Best Practices Across Industries and Functions 

Consultants know and follow Best Practices across regions and life science industries (pharmaceuticals, biotechnology, medical device, diagnostics, nutraceuticals, etc.). They work with companies that are in the front lines of innovation and are at the forefront of new technology and products. Consultants also have experience resolving issues, such as an FDA Warning Letter, for multiple client sites across the globe. Because the consultant has spent time with various companies in the same industry, they can provide market analysis, perspective, and suggestions on how to outperform competitors or resolve issues. In each situation, consultants provide strategic project plans, thorough project documentation, and successful project execution. Consultants know how to approach and solve problems, how to avoid and mitigate risks, and successfully execute projects that those in your existing organization may have never encountered. 

2. Save Cost 

As new projects get added to a company’s portfolio of active projects, additional personnel and resources are required. Consultants may have an initial appearance of being more costly than hiring a full-time W2 employee, but in the long run, hiring consultants costs less than hiring your own staff. Companies that hire their own W2 employees need to spend additional funds on employee benefits, cost of recruiting and HR administration, cost of training, cost of ramp-up time, cost of schedule delays, cost of termination should the hire not work out, and more. In addition, because consultants only get paid for the services needed and each hour paid is allocated to a specific deliverable, work efficiency and productivity is guaranteed.

3. Prevent Schedule Delays 

Schedule delays and project cancellations can occur due to resource constraints for many promising projects. Schedule delays can be detrimental to company finances and can result in projects exceeding projected budgets or project cancellations. Existing employees have day to day operations to maintain, and in many cases, it is not practical to reallocate hours to new projects. Lack of resources can lead to projects being planned and executed ineffectively and inefficiently, thus not meeting planned schedules or simply having poor quality and output. Some methods in which consulting companies can support bring time-constrained projects to life are: 

– Bringing 1-2 consultants as support staff to ease the workload. Consultants can take on junior level roles for Managers and Senior employees to focus on the planning and execution of projects. Consultants can also come in at Senior Level roles to provide direction, expertise, support in planning, executing, and monitoring and controlling projects.

– Hiring a team of consultants to execute a project under an Existing Manager. The Manager can offload tasks to consultants, while managing existing and new projects. Additional support will provide relief for the Manager, while ensuring the project gets completed.

– Hiring a team of consultants as a Managed Service, where a consulting team develops and executes the entirety of the project scope and deliverables, budget, schedule, and resources.

Consultants have a breadth of experience tackling and resolving similar issues with a fast learning curve. Hiring someone with subject matter expertise can prevent schedule delays and provide a shorter ramp up time, thus saving project timelines and cost. Whether the need for someone to fill the gap is short-term or long-term, consultants can enter projects with little notice, and get the project off the ground. 

– For short-term needs, consultants can essentially “plug a hole” while a full-time resource is being sought after. 

– For long-term needs, consultants can continue to support projects even after final teams are established, or they can serve as long-term, highly skilled employees who can train new project team members. 

Consulting services can bring your projects to fruition with industry Best Practices, while saving cost and preventing schedule delays. To learn how PSC Biotech Corporation can support, reach out to info@biotech.com.

Computer System Validation: An Overview

Computer System Validation: An Overview

Computer System Validation (CSV) is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the  integrity of its data to ensure the safety and effectiveness of the product. In the United States, the Food and Drug Administration requires regulated companies to perform validation of computerized systems that operate or support the production of the regulated products, including Pharmaceuticals, Biologicals, Medical Devices, Infant Formulas, Blood and Blood Components, Human cell and tissue products, etc.

Perform CSV when implementing a new computerized system or when you make a change to a validated computerized system. CSV processes are validation processes, based on applicable regulations and guidance documents, industry best practices, and the intended use of the computerized system being validated. In this post we are going to discuss a few best practice recommendations for effective, risk-based CSV.

Computer System Validation 101

FDA defines software validation as “Confirmation by examination and provision of impartial evidence that software specifications follow user needs as well as proposed uses, and that the precise requirements implemented through software can be consistently achieved.”  In the FDA regulated world, a “computer system” is not just the computer hardware and software, but the entire system, including any equipment or instruments connected to the system, as well as the actions of the users that operate the system, and the Standard Operating Procedures, manuals, and documentation.

CSV ensures that both new and existing computer systems are suitable for their intended use(s), produce correct and trustworthy results that enable regulatory compliance, meet the User Requirements Specifications, maintain required audit trails, and provide the ability to detect invalid or altered records.

The CSV process uses a variety of static and dynamic testing activities that you should conduct throughout your entire software development lifecycle, from system conception to retirement.  You should plan to validate that your system will work in all the situations that you want the system to work in.  Write a CSV Master Plan.  Document your CSV processes.  If you didn’t document your CSV, your CSV didn’t happen.

Plan your CSV activities using some or all of these elements based on your particular computerized system and its intended use(s).

System inventory and assessments determine which systems need to be validated.

System boundary documents determine where your computerized system starts and ends.

Validation plans define the purpose, scope, and plan for the validation study.

User requirement specifications explain what the system should do. For example, “I want to drive 6 people from Reno to Las Vegas (438 miles) in not more than 7 hours”.

Functional need specifications explain how the system will look and function for the user to be able to achieve the user requirements. For example, “The vehicle speed has to be at least 80 miles per hour.”

Validation Risk assessments analyze the failure scenarios in order to determine the scope of validation efforts. For example, “Speeding ticket, flat tire, etc.”

Validation Traceability Matrix references each specification to one or more specific validation tests in the Installation, Operational, and Performance Qualifications.

Network and Infrastructure qualification verifies that the infrastructure, hardware, and software supporting the application system being validated have been installed properly and are working correctly.

Installation Qualification Protocols, Test Scripts, and Final Reports demonstrate that the system has been installed correctly in the user environment.  For example, “What kind of car did I buy?”

Operational Qualification Protocols, Tests Scripts, and Final Reports demonstrate that the various functions of the system do what they are intended to do in the user environment. For example, “Do the tail lights work?  Do the brakes work?, Can I do at least 80 miles per hour?, etc.”

Performance Qualification Protocols, Test Scripts, and Final Reports determine that system does what it is intended to do along with qualified people following SOPs in the production environment even under the worst case. For example, “I drive me and 5 ‘people’ from Reno to Las Vegas.  Did I make the trip in less than 7 hours?”

Validation Reports include reported results, deviation resolutions, and conclusions of all activities in the validation study.

System Release Documentation documents that validation activities are completed, that the system was released by the authorized quality function, and the system is available to use.

Process Improvement – Cut Complexity Costs

Process Improvement – Cut Complexity Costs

Written By: Conor Smith, Technical Writer, Midwest

Quality Document (QD) organization and scaling is an important consideration. There are a number of reasons for establishing and maintaining QDs and many challenges associated with managing QDs are consistent across different industries and applications.

One such challenge is complexity costs. In general, complicated systems are more difficult and expensive than simple systems (the exception proves the rule for complexity costs). A set of complicated and inter-related documents requires much more time to update than a simple set of documents. In part, this is because QDs typically cross-reference other related QDs. Updating one document requires modifying other documents as well. As a system of documents becomes more inter-related, the time to modify elements of the system vs. the total number of the elements of a system is more accurately modeled by an exponential curve than a linear approximation. Taken to the extreme, an accurate model incorporates the fact that in practice, very large numbers of documents become impossible to update. The following example in Figure 1 is aggregated and simplified based on experience in the pharmaceutical industry:

Figure 1: A simple model of Time vs. # of Documents to Edit. Document editing time is not linear (blue line) vs. the number of documents. Instead, the actual document editing time is exponential (red line) vs. the number of documents. The difference (dotted green line) between the curves could be interpreted as the true added value of harmonization. A. For a small number of documents (20) the difference in editing time is small – 40 days for ‘ideal’ vs. 49 days for ‘actual’ – a difference of 9 days. B. For a larger number of documents (40) the difference in time is larger – 80 days for ‘ideal’ vs. 119 days for actual – a difference of 39 days.

Linear model (ideal): Assuming 2 days editing per document, decreasing the number of documents from 40 to 20 would save the company 40 days in editing time. In other words, ideally, a 50% decrease in the number of documents from 40 to 20 is a 50% decrease in editing time.

However, for a complicated system the editing time exponentially increases with the number of related documents.

Exponential model (actual): Decreasing the number of documents from 40 to 20 saves closer to 70 days in editing time. In Figure 1 on the ‘difference’ curve, going from point ‘B’ (39 days difference for 40 documents) to ‘A’ (9 days difference for 20 document) is 30 days. Thus, the complexity savings is ~ a month of editing time. With the exponential model, a 50% decrease in the number of documents from 40 to 20 is a 58% decrease in editing time.

All this really means is that there is value in reducing complexity costs and that. quantitatively, the value is greater than if there was no cost associated with complexity. In practice, there are many strategies for reducing the costs due to complexity. One simple example is a reduction in the number of documents:

Finally, the most cost-effective strategy is to mitigate complexity costs by organizing QD systems before they become overly complex. PSC Software’s highly configurable electronic Quality Management System (eQMS), ACE™, is designed to provide the framework for a highly organized and integrated QD system. Additional offerings including consulting, project management and execution services will optimize your system processes, and prevent run-away costs due to unnecessarily complex documentation. For more information and to schedule a free demo, click here: https://www.pscsoftware.com/contact-us

How To Write An Effective Validation Master Plan.

How To Write An Effective Validation Master Plan.

A Validation Master Plan or VMP summaries how you will qualify the facility, equipment, process, or product. A VMP is part of your validation program that includes process validation, facility, and utility qualification and validation, cleaning and computer validation, equipment qualification, and so on. It is a key document in the current GMP (Good Manufacturing Practice) regulated pharmaceutical industry.

Validation Master plans help organizations define validation strategies and deliver control over a particular process. The VMP is quite different from a validation process or procedure that explains the specific process to perform validation activities. Your VMP also helps you defines anticipated resource needs and delivers key input into the scheduling of project timelines. It documents the scope of the validation effort such as impacted product, processes, facilities, procedures, equipment, and utilities. Let’s take a look at its functions:

  1. Management education: Top management is not always aware of the real requirements for validations and qualifications. They generally focus on finances and business processes. The VMP helps educate management by presenting a summary assessment of what it will take to get the job done.
  2. Project monitoring and management: It includes validation schedules and the timeline for the completion of the project.
  3. Audit the validation program: It includes all activities related to the validation of processes and the qualification of manufacturing equipment and utilities.
  4. Planning purposes: It defines anticipated resource needs and offers key inputs into the scheduling of project timelines.
  5. Documenting the scope of the validation effort: It says what you plan to do and, most importantly, what you will not do.

 

How to Write A VMP?

Have one lead author write your VMP. Use your experts. A team-writing approach can be beneficial because it allows you to use and learn the skills and knowledge from people from different parts of the operation that increases the assurance that all processes, utilities, equipment, and systems will be addressed. A good VMP is an easy to follow plan.

Just write down what you want to do, how you will do it, what you need to do it, what deliverables you will have, and when you will do it. Remember, the reader did not help you write your VMP, so say what you mean in plain language. Keep in mind that your VMP should be as long as required to present the plan in the necessary detail. A good VMP is your plan for validation success.