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.

Cloud-Based Software: Changing the Dynamics of the Life Sciences Industry

Cloud-Based Software: Changing the Dynamics of the Life Sciences Industry

Your Company’s drive to make each person more productive than ever before has led to increasing convergence of the physical, digital, and biological processes and technology you perform into integrated software and automated systems.  The past decade has seen the development of software supporting virtually all of the Life Sciences Industry, first as downloaded software and now, increasingly, as cloud-based software that is accessible to your entire organization from anywhere on multiple platforms.  Innovative companies invest in software systems that support their continuous improvement in compliance and productivity.

How does a software system benefit the organizations?

  • Provides a compliant, secure, flexible, and robust foundation for operations.
  • Let’s you do more with less staff.
  • Enforces your processes.
  • Minimizes delays.
  • Automates Tasks, Record Keeping, and Analytics
  • Enables better decision making with input from data capture and analysis.
  • The system does it your way, so you don’t change the way you work.

PSC SoftwareTM has the cloud-based software products that provide the full featured electronic Quality Management System with unparalleled flexibility to automate your entire business; the world-best, easy to learn, and easy to use real-time inspection management software; and the ready to use, plug-and-play electronic Quality Management System that comes complete with all the documents for your industry segment.

PSC Software Solutions:

  • Adaptive Compliance Engine® (ACE™) is the full featured electronic Quality Management System that allows you to automate virtually any process.  ACETM integrates a wide range of tasks into a comprehensive and seamless platform, including ACE Auditor™, ACE Analytics™, ACE Inspection™, ACE Docs™ for controlled document management, ACE LMS™ a fully integrated Learning Management System, and ACE PLM™ for Product Lifecycle Management.  ACETM is the scalable and highly-configurable enterprise quality management system that easily adapts to any business process to enable tracking, management, and reporting of all compliance, quality, and operational activities in real-time.
  • AuditUtopia® is the world’s-best, stand-alone, real-time inspection management system.  AuditUtopia® is the software tool that allows your inspection team to streamline request handling and improve response time.  AuditUtopia® is so easy to use that your entire team can learn to use AuditUtopia® in less than a day.  AuditUtopia® is designed to keep your audit team organized, ensure a free flow of information, and address and track priorities.  Whether you have any Quality Management System, when it comes to inspection management AuditUtopia® gives you all of this capability and more for an incredible price:
      • Configurable Reports
      • Log Inspection Notes
      • Real-Time Updates
      • Chatrooms and Private Chats
      • In-System and Email Notifications
      • Track and Manage Requests
  • ACE Essentials™: ACE Essentials™ is the complete, fully validated, Turnkey Electronic Quality Management System (EQMS) software created for highly regulated industries. ACE EssentialsTM comes with all the necessary standard operating procedures and policies to deliver you fully compliant quality management system at an unbeatable price. ACE EssentialsTM includes document management; training management; deviation;  investigation; corrective and preventive action; design control; risk management capabilities; and much more, ready to use and fully compliant.

Cloud-based Life Science Software lets your organization ensure compliance and data integrity, respond faster, reduce time to market, address regulatory issues efficiently, and ensure continuity.

If you need more than just software, PSC Biotech™ can provide your company a full range of professional services, including computer system validation, equipment and facility commissioning, qualification and validation, risk assessment, temperature mapping, staff augmentation, and more.  PSC Biotech™ provides professional services as customized engagements tailored to your needs or under Master Services Agreements that allows you to use the services you need when you need them at an agreed cost.   Our experienced consultants are ready to help your company succeed.  Whatever your requirements, PSC Biotech™ will work with you to make it happen!

Working Remotely Due to COVID-19? Let PSC Introduce You to ACE and ACE Essentials!

Working Remotely Due to COVID-19? Let PSC Introduce You to ACE and ACE Essentials!

Written By: Kelsey Quargnenti, Senior Marketing Specialist, Midwest

PSC Software understands the business challenges companies of all sizes are facing at this time. Forced remote working during the COVID-19 pandemic is significantly affecting the way all companies operate and for over ten years we have been committed to keeping up the pace!

PSC Software Solutions features two of our systems, ACE and ACE Essentials™. Both are cloud-based software that can handle speed and complexity, allowing your organization to work remotely during the new normal. With end-to-end solutions, our software allows you to flexibly and seamlessly run your businesses on your own terms, without suffering within the awkward confines of a one-size-fits-all platform.

Our consultant work is being performed remotely though our complimentary system Easy PSC Access, used for our clients, ensuring projects stay on track while using ACE to securely transfer files back and forth in a secure electronic system. 

By utilizing ACE for your company, you can scrutinize ever-growing sensitive and confidential datasets, realize faster responses and reduce time to market, address regulatory issues with ease, and ensure business continuity. Implementing a cloud-based digital business architecture will better enable your company to break free from the traditional legacy IT system and all the outdated constraints that encumber your progress during this stressful time encouraging a successful work-life.

Help beat COVID-19 and go electronic!

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.