ACE SuperVision™ for Google Glass Enterprise 2.0

ACE SuperVision™ for Google Glass Enterprise 2.0

PSC™ has recently taken the software you know and love, ACE™, and integrated it with Google Glass Enterprise! ACE SuperVision™ allows companies like yours to put safety first while streamlining your workflow processes. Together, you will have the same capabilities you’re used to in a new and innovative form! With ACE SuperVision™ on Google Glass, employees can integrate instructions and outcomes in real-time. Employees are free from bulky clipboards, phones, and tablets for faster and safer work. Additionally, Google Glass provides another layer of protection by meeting safety goggle standards. Now your company can be more efficient while being safer than ever!

What is it?​

ACE SuperVision™ is an application from PSC Software™ that integrates wearable technology devices with PSC™’s Electronic Quality Management System, ACE™. With this system, requests can be sent to the user’s device to be filled. Also, ACE SuperVision™ syncs Google Glass documentation to your ACE™ database. ​​

Why we need it?​

Before COVID-19, industry trends showed a growing interest in hosting inspections and audits in remote settings. During COVID-19, PSC Software™ anticipated the urgency to develop a solution for remote inspections and audits. We want to expedite bringing products to market and improving the quality of life for patients.​

Who will use it?​

Any industry that hosts audits and inspections will capitalize from using ACE SuperVision™ on wearable devices. ACE SuperVision™ has numerous features, including Speech to Text, Audio Recording, Video Recording, Taking Photo Images, Scanning QR Codes, Video calls, Text Instruction, and more. For example, you can host audits and inspections virtually, view instructions from your glasses, and operate equipment safely with both hands! 

ACE SuperVision for Google Glass

Current Problems

  • Restrictions for personal interaction due to COVID-19 have created delays in regulatory and supplier auditing.
  • Some industrial environments require a lot of hands-on activities and handheld devices.
  • Users might need to utilize other devices to browse instructions frequently.

Our Solution – ACE SuperVision™

  • ACE SuperVision™ supports virtual Video calls such as Zoom and Jitsi.
  • Both parties can progress in audit activities via a remote environment.
  • An operator, calibration technician, or QC Analyst can conduct activities hands-free, improving productivity and safety.
  • Provide predefined request instructions on the screen of the wearable device for easy follow-up.

PSC™’s newest software, ACE SuperVision™, is at the forefront of efficacy solutions in the pharmaceutical and medical devices industries. We created software for rapid and agile data gathering, equipment management, workflow mastery, audits, and more. Be on the cutting edge with wearable devices and enhance your capabilities!

If you are interested in our adaptive compliance engine, ACE™ go to PSC Software™. Furthermore, contact Emily Lee for information and Ryan Ciarcia for purchasing! In addition, enhance your progress with our professional services at PSC Biotech™.

The Importance of First Impressions on Inspection Day

The Importance of First Impressions on Inspection Day

What are you and your team doing to win on inspection day? Preparation for inspections is an ongoing process. You likely have a lengthy checklist of items that must go perfectly on the day of an inspection. However, many inspection readiness teams overlook the importance of first impressions. According to FDA inspectors, a positive first impression can result in quicker and smoother inspections. So, how do you prepare your team to make a great first impression?

Whether your team makes a great first impression is determined long before the inspector arrives. For instance, are the greeters well trained and prepared for inspection day? Greeters should welcome the inspector, take the inspector to your inspection room, and alert the team of the inspector’s arrival. If the inspector visited your organization in the past, a representative acquainted with the inspector should lead the opening meeting.

Greeting

During the opening meeting, the team should keep to a time-appropriate script. Give an introduction, go over the scope and schedule, provide the inspector directions to the restroom, and discuss lunch plans. Being a gracious host should be number one on your inspection day checklist. One simple thing you can do to show respect is to ask if the inspector has any dietary restrictions and go through your scripted introduction. Considerate hosts appear more experienced and prepared, which can influence the outcome of an inspection. Suppose the inspector is unfamiliar with your operations. In that case, they may request a brief tour of the facility after settling into the inspection room.

Inspectors frequently arrive unannounced, and sections of the facility may be cluttered due to everyday work activity. At the beginning of the tour, the guide should lead inspectors through the cleanest areas of the building. Inspectors often associate a clean work environment with a cGMP compliant organization. Additionally, ensure that all employees are following your written and approved gowning procedures. As they are guided through the facility, inspectors watch for inconsistencies; so, personnel attire must be consistent and by the book. Practice giving the tour to your own staff “inspectors” to ensure your team is prepared for inspection day.

Furthermore, there are several common requests that the inspector will always make at the start of an inspection. These requests are often referred to as “pre-requests”. They can include the index for SOPs, maps of the facility, product flows for the facility, SOPs on training, etc. Quickly delivering the documents that are commonly requested at the onset of an inspection will give the inspector the impression that your facility and quality management system operate in a “State of Control.”

Inspector in protective uniform with hairnet and mask taking parameters from industrial machine in a lab

Inspection readiness is crucial to the success of organizations in highly regulated industries. In many cases, a favorable first impression is merely a great start but not enough to win on inspection day. However, implementing an Inspection Management System such as AuditUtopia® or ACE Inspection® can streamline your inspection processes. PSC’s Inspection Management Systems allow your team to take scribe notes, manage requests, collaborate on requests, and report on inspection data, all within a unified and secure platform. To help prepare documents and your team for inspection day, consider our consulting services at PSC Biotech.

For a free demonstration or more information on industry-leading Inspection Management Systems, visit pscsoftware.com or contact PSC Software™ at sales@pscsoftware.com.

The Importance of Computer Systems Validation

The Importance of Computer Systems Validation

Validation is essential in maintaining the quality of your products and a key requirement for GxP compliance. This is necessary not only for your facility, equipment, products, and processes but also for your computer systems. We focus here on computer systems validation. 

Computerized systems and software validation (CSV) provides evidence that your systems are compliant with current regulations and are suitable for their intended purpose. You want to proactively perform CSV to ensure that your systems do what you intend, maintain data integrity, and meet regulatory agency requirements. Your computer systems should protect against: damage, shutdowns, distorted research results, product and sample loss, unstable conditions, and any other bad outcome you can forecast.

Once you install and validate a computer system, you need to keep its hardware and software updated. You need to perform validation studies to show that these updates to hardware and software maintain the validated state of your computer system. These continuous validation measures enable you to avoid errors in computer systems that “magically appear” after software upgrades or hardware changes.

Also, you want to consider your computer system validation when you start a new product or upgrade an existing product. Ask the question, “Do we have evidence that the computer system will work for this new product or upgrade, etc.?” If your answer is No, consider validating your computer system for this change. Then you’re ready for a running start!

 

Validation

PSC Biotech can provide you the highest quality CSV services on any scale. Our Computer System Validation experts, experience, and processes prevent overlooking small details and help you smoothly implement robust validation procedures. Contact us now for tailored computer systems validation professional services consulting! 

Validation
Effective Risk Management For Medical Devices

Effective Risk Management For Medical Devices

Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.    

A Hazard is a potential source of harm.  A Risk is your estimated probability that a Hazard occurs for your medical device and the severity of that Hazard to patients, users, etc.  So, how do you do risk management?  You start with ISO 14971.

ISO 14971 is the International Standard that specifies terminology, principles and a process for risk management of medical devices, software as a medical device, and in-vitro diagnostic medical devices. 

The ISO 14971 process will help you identify the risks associated with your medical device, to estimate and evaluate the risks, the measures you use to control these risks, and to monitor the effectiveness of your controls.  Your risk management process applies to the full spectrum of risks including, but not limited to  biocompatibility, data and systems security, electricity, moving parts, radiation, maintenance, calibration, transport, and usability.  ISO 14971 does not specify acceptable risk levels.  You set objective criteria for risk acceptability and you set the acceptable risk levels.

medical device

Remember, an effective risk management program isn’t just a one-time exercise, it is an ongoing part of your product life cycle. Effective risk management helps you protect your patients, your products, and your reputation.

ISO has recently updated ISO 14791 with ISO/TR 24971:2020.  This technical report includes additional guidance on the principles and the process for managing risks associated with software as a medical device (SaMD) and in-vitro diagnostic (IVD) medical products.  You want to review and update your risk management process to apply the principles in ISO 14971 and technical report ISO/TR 24971 to make your risk management program optimally effective.

PSC Biotech® has experienced risk management professionals who can help you establish your program and provide risk management services tailored to your needs.  Call us today and let’s talk about effective risk management.

How Outsourcing Professional Services Can Boost Your Company

How Outsourcing Professional Services Can Boost Your Company

Written by: Tom Kelland, Director of Southwest Operations at PSC Biotech™

Utilizing outsourced professional services can help boost your company in many different ways. This is especially true when working in a heavily regulated industry where expertise will save time and minimize costs. Outsourcing professional services provides benefits to companies of all sizes, including:

  • Gives your employees more time – Outsourcing specific professional services gives your employees more time to perform their routine activities. By not having to learn new functions that are outside the scope of their core role your employees can focus on their essential tasks.
  • Quality Assurance – Using experts provides assurance in the quality of work that is performed. This means no rework or editing work, when it is complete you can move onto other tasks.
  • Less Human Resources Requirements – Employee management can be costly and complicated! By outsourcing professional services there is no need to worry about employee management and the costs associated.
  • Availability of Expertise – Sometimes there are problems that your company will face that no one within your organization has the expertise to resolve. By outsourcing your professional services, you have expert resources at your fingertips.
  • Work Gets Done Quicker – Outsourcing leaves complicated tasks to experts who have experience executing similar work. This results in tasks getting done sooner than they would have if you kept the task for your own employees. This helps you meet tight timeframes.
  • Accelerate the Learning Curve of Your Employees – Your own employees don’t have to slowly learn the task at hand and absorb the mistakes that come with that learning. Expert professional service providers can train your employees while executing tasks to accelerate the learning curve of your employees without the risk of costly mistakes that slow your operation.
  • Have Better Control of Your Varying Workload – Your workload can vary greatly depending on initiatives and demands in the market. When you outsource professional services you don’t have to take on the risk of hiring full time employees for the times when workload is high. Outsourcing allows your business to adapt easily when a workload surge decreases so you can maintain a lower headcount.

It is clear that outsourcing professional services will help your company with time and cost savings, flexibility, subject matter expertise, and quality of work. Outsourcing lets your team focus on their core work, spend less time and avoids costly mistakes.

Contact PSC today to learn how our Outsourced Professional Services can help your business and the flexible solutions we can provide to meet your business needs.

 

Starting A New Laboratory

Starting A New Laboratory

Written By: Matthew Greer, Technical Writer, PSC Biotech®

Introduction

Starting up a new laboratory can be a daunting task. What regulations need to be followed?  What kinds of products are you handling?  What kinds of tests will you do?

Once you know this, you need to consider the best layout for your laboratory.  You need to identify the test and laboratory safety environment.

Let’s discuss a few of the factors you want to consider in planning your new laboratory.  First, having the right team is essential, and if you need help, PSC Biotech® has the resources that you need.

Avoid the Common Mistakes

Before breaking ground, you need to consider how will you laboratory be utilized? What products will be tested in this lab? What are the methods associated with these products?

Are there any safety equipment or special requirements necessary for each one? Fire extinguishers, eye wash stations?  Fume hood, Biosafety Hoods, Glove boxes? Gowning, Degowning?  Chemical and Biohazard Waste storage?  Autoclave or Dry Heat Oven?  Flammable, Acid, Base, and Oxidizer storage?  Personnel low, Sample flow, Sample Storage?  Design your laboratory on paper first.

You must understand the tests the laboratory will be asked to perform, including chemistry and microbiology tests for raw materials and in-process, final product, stability, and validation samples. 

Next you need to select the appropriate test equipment to perform the tests.  How accurate, how precise, how sensitive, etc. does the equipment have to be?  Oh yes, and remember that everything needs to calibrated.

Which type of utilities will be needed? Electricity, Gas, Air, Nitrogen, Vacuum, Water?

Do you need Purified Water, Water for Injection, Distilled Water? Make sure the correct water systems are installed for your planned testing.

Do you need to control the laboratory temperature and relative humidity?  How about vibration or light?  Do you need an ISO classified environment, such as an ISO 5 room or hood for aseptic operations?

Don’t forget the Paperwork

What about your quality management system?  Policies, procedures, forms, records, etc., are essential.  If it isn’t documented, it didn’t happen. If you need a Quality management System that is plug and go, consider ACE Essentials™, our cloud-based fully cGMP compliant system that comes with all the necessary Standard Operating Procedures (SOPs), quality event management, training management, and even more features to have your new laboratory in compliance from its very start.

These are just a few of the things that you need to consider when starting up a new laboratory.  Overwhelming?  PSC is here to help.

About PSC Biotech®

PSC Biotech® is a life science and biotechnology consulting company founded in 1996.  We can provide you a complete turnkey solution or with the specialized, qualified consultants with expertise in the areas you need, such as laboratory operations, writing documents, validating equipment, analytical methods, validation, and gap assessments.    

Let’s get your new laboratory up and running!  Contact us today!

Stay In the Loop - Join Our Newsletter