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:

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.

Ready to leave Paper behind? Covid-19 Exposes the Need for Quality Software Solutions

Ready to leave Paper behind? Covid-19 Exposes the Need for Quality Software Solutions

Written By: Cynthia Gross, Product Director

PSC Software understands the business challenges companies of all sizes are facing. Forced remote working during the Covid-19 is pandemic affects the way all companies operate.  If your quality management system is paper based or you need to move to an electronic Quality Management System, this can place additional pressure on your team. PSC Software has solutions to keep you compliant and productive in this unprecedented business climate. To help companies respond to these challenges as quickly as possible we have launched ACE Essentials™, the turnkey eQMS solution!

The ACE Essentials™ Electronic Quality Management System software includes the following:

  • -Document Management
  • -Training Management
  • -Quality Management

ACE Essentials™ features:

  • -Pre-configured workflows based on best practices
  • -Over 50 SOPs, Policies and Forms
  • -Self-learning training with step by step videos
  • -Ability to implement quickly
  • -IOPQ Validation included
  • -Technical support and perpetual updates

Please stay healthy and safe during the current pandemic, and contact us for a demonstration to take advantage of ACE EssentialsTM, the easy to use, full-featured eQMS solution.

The Impact of Computer Software on Biotech Industry

The Impact of Computer Software on Biotech Industry

The impact of computer software on Biotech and medical industry is immense. Thanks to the advanced technology, we can rely on computer software to design experiments, interpret data, store data, and provide results. There are several types of software, including product specific software, laboratory management software, and software for bio-imaging. When it comes to considering new Computer Software for Biotechnology, it is highly important to investigate its compatibility of operating systems, drivers, and instrument components. Computer software can go outdated quickly, so look for its ability to upgrade.

The IT department in an institution may need a consultation to integrate new technology into laboratory information systems. It would be beneficial to look for the companies that provide friendly technology support to help you get your new system up as well as running.

Biotechnology Software in the Digital Age

The digital revolution has taken place everywhere, and biotechnology companies have also adapted it. There are a number of pharmaceutical, biotechnology, and industrial bio-production companies believe that computer software must be developed and maintained in-house so that the data can be safely stored on their internal servers than on the cloud. In fact, most of the reputed companies continue to employ large IT and software teams in order to obtain computational infrastructure in the form of in-house servers. This is because of the fear of the cloud not appropriately protecting their in-house resources and the belief that their software is precious IP.

Over the past years, the ability to adapt to the changing conditions of the market will become a compelling competitive benefit. Biotechnology companies that do not adapt to the new changes may lose on key business metrics, including capital, revenue, profitability, and market share as well.

Biotechnology – Introduction

Biotechnology is an industry prime for disruption for several reasons, including

    1. It is growing frequently with rapid IPO activity, which makes a market entrance for small start-ups with venture capital backing a high probability.
    2. The tools and techniques are highly advanced with the price of reading as well as writing DNA falling faster than Moore’s law predicts.
    3. Rising levels of investment in biology bring the size of Series B rounds to $50 million. It allows small companies to enter the space with completely automated laboratories as well as production capabilities.
    4. It increases the availability of affordable infinite computing capacity that removes the need for expensive, on-site infrastructure.

Software in Research & Development groups is covering behind the existing technology landscape. Industries employ smart people, pay them money, and provide poor tools to meet their design work. In many cases, a scientist works the applications that are less innovative, less protected, and deliver an inferior user experience as compared to the applications this same scientist can provide with advanced tools and technology. Talking about biotechnology, operations in most large and even small biotech companies are fully automated pipeline. Computer-aided manufacturing (CAM) for biology is solved.

The level of automation in the pharma laboratory matches advanced manufacturing facilities like those in the automotive world, and they can get the advantage from software advances in the computer-aided manufacturing world for over 40 years. Instead of developing software in-house, companies prefer to use off-the-shelf design and infrastructure management software for their automated lab designs and their factories as well as production centers. In addition to the biotech industry, just as all industries will be computer software over the next decades. And, they may not end up with data leaks, massive and expensive software teams, scientists, and senior management team wondering how they lost.

Why Gap Assessments are Important to Accelerate Success

Why Gap Assessments are Important to Accelerate Success


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

Are you finding yourself with repeated deviations or complex processes that slow you down? Did you go into an audit feeling ready and came out the other side blindsided by a 483?

Making multiple changes in processes over time, whether to prevent deviations or adapt to changing regulations, may create hidden obstacles, unnecessary or redundant steps, and broken links in procedures.  You may end up with standard operating procedures that no longer talk to one another properly, thus creating more deviations when an employee gets confused.

Identifying your desired state of operations and seeing your future state operations can be overwhelming.  How do you get to your future state without stopping and starting all over?  A gap assessment can help identify broken links and streamline processes to accelerate your success.

A gap assessment will compare your current state of operations to your desired state of operations.  In doing so, the analysis will identify gaps and areas of improvement.  In general, the steps of a gap assessment include:

  1. Identifying and documenting your future goals or desired future state of operations.
  2. Identifying and documenting your current state of operations.
  3. Comparing the current state of operations verses the future state of operations.
  4. Using gap analysis tools, such as Ishikawa, to find potential gaps and identify potential solutions.
  5. Evaluating the potential solutions by developing a plan to test one of the solutions.
  6. Testing one of the potential solutions with a small-scale study to see if processes improve.
  7. Analyzing the results of the study.
  8. Creating a plan to bridge the gap and implement the successful change into the routine process.

PSC Biotech™ provides custom fit options to help companies perform gap assessments of their operations.  Because regulations and guidance documents are periodically updated to help the industry adapt to current Good Manufacturing Practices, adjusting to the changes can be difficult for small and large companies alike.  Experienced consultants are available to perform gap analysis to ensure your current processes are compliant.

PSC Biotech™ has a wide variety of solutions to ensure success for any size company.  Some of our offerings include consulting, performing risk assessments, writing standard operating procedures, writing protocols, writing white papers, project management or even executing projects to free up your company’s valuable resources.  Whatever your need may be in the life science industry, PSC Biotech™ will be there to help. Give us a call today!

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

Case Study Overview

In highly regulated industries, you can count on the fact that your company will be inspected a time or two by regulatory agencies and/or your clients. Most companies manage these inspections using a mixture of programs for different aspects of the inspection. A leading problem with that approach is that these programs do not communicate with each other or update automatically.

Ridding Manual Processes During Inspections

Thermo Fisher Scientific’s Viral Vector Services (VVS) division (formerly Brammer Bio) is a contract development and manufacturing organization (CDMO) with three cGMP facilities and over 100 successful client projects under their belt. With multiple facilities and clients, the VVS division was being inspected two times per month. During each of the inspections, the team was using multiple tools to manage inspections requests and to communicate between the inspection room, support room, and employee’s in the office.

Audits and inspections undoubtedly call for numerous teams working simultaneously to fulfill requests. When these teams are not in sync, opportunities for missed and incomplete request responses arise. This causes strain on the inspection process as well as on the employee’s tasks.

For these reasons, Thermo Fisher brought on AuditUtopia®. Prior to AuditUtopia, Thermo Fisher managed the communication and requests surrounding the inspection using manual tools to communicate with those outside of the inspection room.

For example, the team would use a shared Microsoft OneNote folder to keep notes and track requests. The OneNote method required the team to enter basic information such as request number and type of request and track the progress of the request manually by refreshing the OneNote file. This made communication difficult and left notes unorganized.

The Cost of a Failed Regulatory Inspection

With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest for its responsiveness, ease of use, implementation program, and single platform solution for all their inspection management needs.

Switching to AuditUtopia®

For most companies, the thought of implementing a new software to replace an established system is daunting. PSC Software™ aims to mitigate the stress and learning curve that often comes with the implementation of a new software by providing trainers who are subject matter experts on the program along with recordings of the same trainings as a reference documents for future employees.

Gaining Peace of Mind While Achieving Results

Following a seamless implementation process, the Viral Vector Service’s inspection management team is able to stay organized and on-topic of the requests and inspection as a whole. Rather than playing “telephone”, the team is relying on first-hand, written accounts of what is being said in the inspection room.

The Thermo Fisher VVS team can now track the status of each request in real time and view metrics on where they struggle to answer requests in a timely, efficient manner.  With the implementation successful, Thermo Fisher and PSC Software™ look forward to a successful long term partnership.