Computer System Assurance: A Paradigm Shift Away from Compliance to Quality

Computer System Assurance: A Paradigm Shift Away from Compliance to Quality

Written by: Gary E. Ritchie, MS, Senior Validation Engineer Consultant, PSC Biotech Corporation 

The FDA will release the draft guidance on Computer Software Assurance for Manufacturing, Operations, and Quality System Software in late 2020. The new draft guidance will apply critical thinkingassessmentand risk tools for assuring that data for the manufacture of drugs and devices meets their product quality specifications, ensure patient safety, and conform to data integrity requirements for complete, consistent and accurate records throughout the computer software lifecycle. The new approach in this draft guidance differs from the current validation approach in several ways, as it is a shift away from a compliance approach to a quality assurance approach.    

Although the draft guidance will be issued by the CDRH, you know that FDA will apply it Agency-wide, which means you need to know what FDA will expect. The change to a quality focused approach comes out of the FDA’s The Case for Quality (CfQ) Program, launched in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders.     

FDA envisions that a focused and leaner approach will lead to reduced documentation and faster qualification of computer software before, during, and after manufacturing, testing and releaseFDA expects that the new framework will assure that requirements for computer software, hardware, and integrated system maintenance, change control, qualification, verification, validation, and data integrity are met through this quality and risk-based approach. 

Since automated computer controlled systems and software are often also used in in the production of biologics and drugs, the guidance will impact these areas as well. 

FDA wants to ensure that you have adequate controls in place for your computer software and systems. You will get increased product and patient safety and reduced risk wherever data is used and generated by software and automated computer controlled equipment. PSC™ can help meet your quality needs for computer systems quality assurance under this new paradigm. 

Applying Aseptic Practices to Protect Yourself From COVID-19

Applying Aseptic Practices to Protect Yourself From COVID-19

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

Hi everyone, I am Crystal Booth. I am currently a Regional Manager for PSC Biotech. I have been working in the pharmaceutical microbiology, environmental monitoring, and quality assurance arenas for the last 20 years. I identify myself as an industry expert in microbiology and quality assurance. I obtained my master’s degree in microbiology from North Carolina State University. I am a seasoned award-winning technical writer and authored the book “Method Development and Validation for the Pharmaceutical Microbiologist.” During my career, I have worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. I have developed and validated numerous microbial methods, validated equipment, lead projects, audited companies, and worked with many different product types.

I wanted to share a past article that I wrote for the industry. This article is focused on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet. I feel it is a very important topic for our current unprecedented times. I hope everyone stays safe and healthy! Please enjoy the article which can be found below.

What is Data Integrity and Why Should You Care About it in Your Lab

What is Data Integrity and Why Should You Care About it in Your Lab

Written by: Chris Pardo, Associate Business Development Manager

When you run a test and you get a result or OOS you don’t like, you wish you could delete it and just run a re-test, but we don’t. There is a very good reason we do not do this and you probably aren’t aware you are already complying with data integrity. Data integrity is essential for the life science industry. Most people don’t know why we have data integrity or what it is. Let’s go into what data integrity is and why it is important to maintain.   

What is Data Integrity 

We all have heard the phrase, “if it isn’t written, it didn’t happen”. Data integrity follows that, but takes it up a notch and expects the data to be attributable, legible, contemporaneously recorded, original or a true copy, and accurate  (commonly known as ALCOA). To ensure that data integrity is being met, there must be a record of anything that is changed from the original document while keeping the original document intact. When making a change a reason must be given and recorded. This brings us to an audit trail.  

Following the Trail 

The FDA defines an audit trail as a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the events relating to the creation, modification, or deletion of an electronic record. The audit trail shows us who made changes, why the changes were made, when they were made and what changes were made  

What it All Means

What data integrity means is that not just anyone can either alter data, erase it, or make any changes to a document without a record of the changes being made in an audit trail that can be reviewed. Severe penalties can occur due to not following data integrity such as a warning letter and criminal prosecution. Everything is recorded and made available for review by anyone.

Data Migration: Being Prepared

Data Migration: Being Prepared

Written by: Alan Pham, Business Development Associate 

In a world where our data is crucial to our everyday lives, implementing new platforms is necessary when our data becomes more robust. Data migration is a very vital component to ensure a smooth implementation process, which can be a daunting task if you are not prepared. Some of the key points that will ensure the implementation of your new platform goes smoothly include aligning the data with the correct business users, evaluating the existing data, and validating the migration process to ensure timelines are met.   

Here at PSC Biotech™, we can help you ensure that your precious data from your legacy system is correctly migrated to your new platform. A key point to keep in mind while you are migrating data is to bring in people who will be using the data. These folks can provide insight as to how and why specific data is being used, which can give you an idea on how the data should be organized. After all, the newly purchased 

system is to make our lives easier while giving us more bandwidth to focus on our research. In order to organize the data, we will assess your database to ensure that all data points are migrated, and that no data point is left behind. PSC Biotech™ will validate the data coming from your legacy system, ensuring its integrity is up to expectations. Like they say, “Garbage In, Garbage Out”.  

During this whole process, PSC™ will ensure that the actual migrating of the data is validated and tested. Data testing, validation and migration must fit the project timeline to ensure the system can “Go-Live” on time. PSC™ has the expertise to assess your data, validate your data, and manage your project so that all timelines are met.  

Quit Wasting Valuable Time; Electronic Systems are Here to Help!

Quit Wasting Valuable Time; Electronic Systems are Here to Help!

Written by: Andrea Salive, Business Development Manager

The Life Science industry is making groundbreaking advances now more than ever and although rapidly evolving, there’s something the industry isn’t fully caught up to speed on- automated digital processes.  

Gone are the days of office spaces consumed with filing cabinets, manila folders and stacks of white papers collecting dust. So, what’s stopping you from making the upgrade and being one with the times? Perhaps your paper-based system is working “just fine,” implementing a new internal process isn’t within your financial budget or maybe the fear and automation anxiety is stopping you in your tracks. No matter what that reason may be, let’s look at what benefits an Electronic System can bring to your organization and why sticking to your “norm” may be hurting you.  

We’ve all dealt with these types of situations in the workplace before; lost files, missing signatures, forgotten deadlines, misplaced documents, etc. Life Science organizations understand the criticality with following internal processes and how one simple mistake can result in significant setbacks. Paper-based processes allow for great probability for human error to occur in even the simplest tasks, for example, punching in the wrong number or misplacement of a decimal point which can all have a devastating impact. How can an Electronic System help reduce this? By implementing an Electronic System, an organization can define that same existing process electronically to ensure that all employees follow it while also eliminating the opportunity for employees to deviate from that process. Think of an Electronic System as train tracks. Train tracks enable a train to move from point A to point B by providing a dependable, streamlined path.

In addition to harmonizing internal processes, Electronic Systems can also save an organization a lot of time and money. When employees are responsible for lengthy, monotonous tasks such as updating documents via manual data entry, a lot of time is absorbed resulting in decreased productivity and you know what they say, “Time is Money. When transitioning to an Electronic System, the amount of time now saved, leads to an increase in productivity and allows for bringing products to market faster, resulting in higher revenue. Other areas of savings an Electronic System can help to support are general hard costs and sustainability. Moving from a paper-based system allows an organization to save on the amount of paper they expend leading to a more sustainable workplace and environment.  

Electronic Systems are being designed to meet the needs and standards of the Life Science industry which is another reason why transitioning to an automated process can increase effectiveness and efficiency. When operating a paper-based system, there’s potential for major risks associated with Data Integrity and confidentiality. Electronic Systems, such as PSC Software’s, ACE™, was created to meet industry standards by offering a system that is 21 CFR Part 11 compliant with electronic records and signatures. This also alleviates the stress of manually tracking documents as there are validated audit trails and system logs. 

Another point to include here that makes an Electronic System more efficient within your organization is the accessibility factor. Software as a service (Saas), Electronic Systems are hosted within the cloud meaning you can access them from your phone, tablet, or desktop at any time. Rather than shuffling through files and outdated paperwork, one simple search within your electronic records and voila, how simple is that! No need for any more of those late nights at the office when you can access everything you need at the tips of your fingers in the comfort of your own home. Not only does this make you and your employees’ day to day easier, it again supports an increase in productivity and effectiveness. All in all, the accessibility factor is what can really give you an advantage and separate you from your competitors. 

In conclusion, Electronic Systems are constantly emerging and aren’t going anywhere anytime soon. As scary as change may be, establishments like PSC Software™, for example, are here to assure your transition to an automated process is completed seamlessly. These systems are here to simplify your processes while growing and scaling as your organization does. So, what are you waiting for- click here to schedule a free demo or here to learn more!  

Not Performing a Risk Assessment is a Risky Business

Not Performing a Risk Assessment is a Risky Business

Written by: Wayne Berry, Quality Process and Computer Systems Validation Manager

We perform risk assessments in every part of our life… choosing a safe car for our new teenage driver, making sure the car seat is properly secured for that newborn’s first ride home, wearing a helmet when biking or putting on a flotation device when out on the water.  Yet, there are times in our professional life that we are more focused on ‘getting things done’ today and not thinking about what could go wrong in the future.  And things do go wrong. 

A well-thought-out risk assessment program covers all aspects of our business and isn’t a one-time review when making changes.  The COVID-19 crisis has impacted everything we do and is shining the light on the strengths and weaknesses of our operations.  Now is the time to take a holistic review of how we have  historically  evaluated and rated  risks  in our operations.  We should review these risks and compliantly implement  new  adjustments to our  processes if necessary.

One area that may not receive the attention it needs is  our material suppliers.  We develop a level of comfort with established suppliers that have been dependable, consistent and provide quality materials.  And we lower the perceived risk that this supplier will fail us.  With COVID-19 impacting all businesses, how is it impacting your suppliers?  Will they be able to ramp up and meet your needs?  Will you be competing with their other customers for limited inventory?  Do you have alternate suppliers qualified and available to address any gaps? 

Thorough risk assessments allow us to identify and develop plans to address unforeseen problems in a controlled manner, allowing our resources to focus on instituting the solution instead of solving the problem.  Don’t let the lack of risk assessments turn a good business into a risky business.   Give PSC a call today!  We have experts standing by who can help with risk analysis and mitigation.