Calibration Management Made Easy

Calibration Management Made Easy

Written By: Chandler Conley, Business Development Manager

Accuracy of equipment for testing and measurement is necessary for developing and manufacturing critical products, pharmaceuticals, medical devices and more. If you have a well-organized calibration program, you minimize your risk of using out of tolerance equipment. Oh yes, your calibration program prevents FDA 483 citations.  Failure to perform calibration, inspection, and checking ranked at number 9 of the top 15 deficiencies in 2014.  Related citations include absence of written protocols, failure to follow written procedures, and the absence of scientifically sound laboratory controls.

You need to decide which pieces of equipment need to be calibrated and how often they need calibration. The obvious list includes critical equipment used for product approval, sensors used for qualifications, and equipment that is used to assure processes are performing as needed.  You also need to consider equipment in your indirect and utility systems.  A comprehensive asset list with calibration due dates, calibration parameters, and processes makes calibration program management easier.  PSC Software™’s (ACE™) electronic Quality Management System provides an integrated quality solution that can manage you calibration program and seamlessly integrate it into your quality system.

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Your “smart” equipment may be able to alert you that calibration is due, such as the Lives International XpertLog thermal validation systems and wireless data loggers, where you can restrict sensor operation if calibration is overdue, or the CLiMET Instruments lines of particle counters, which can be set to not operate if the current calibration has expired. These “smart” instruments add ways to prevent use when calibration has expired. Calibration stickers with due dates on equipment may eventually fall off or wear down on equipment that is cleaned frequently. They also may be in areas that are not obviously visible to users, so built in lock-outs or restrictions are a great backup plan.

If you need support from experts in developing or supporting your calibration program, need  metrology and calibration services, ACE software, or CLiMET Instruments and Lives International equipment sales, please contact PSC Biotech at sales@biotech.com!

The Importance of the Appropriate Architecture in Your GxP Computerized Systems

The Importance of the Appropriate Architecture in Your GxP Computerized Systems

Written by: Justin Jay, Director of Mid-Atlantic Operations

Computerized systems are critical to reducing the cost and complexity to develop, produce, and maintain cGxP compliance for your products.  The architecture and design of your computerized systems leads to maximum efficiency and lower costs to operate and validate your systems. 

Validating a computerized system can be a very costly, particularly if you have bought the wrong system or have designed your systems in a way that makes validation tedious or difficult.  You need to involve specialist and the end users in the design of your systems.  The more complicated a system is the longer it takes for training as well as validation. Technology also is evolving. Additional validation activities may be necessary after software updates and new feature additions. Your computerized systems can turn into liabilities if they are difficult to maintain in a validated state.

 

computerized systems

You can reduce the time spent in computerized system validation.  Focus on the user requirements early in the process.  Select the best tool for your work. If possible, select software products like ACE Essentials, that are fully validated and ready to use, or ACE, the fully configurable electronic Quality Management System that can adapt to any business process.  If you need computerized system validation (CSV) services, select a provider like PSC Biotech who has the experience and capability to validate your software systems on time and on budget.

 

Contact PSC Biotech today for all your software product and computer system validation service needs!

What Kind of Professional Services Does Your Company Need?

What Kind of Professional Services Does Your Company Need?

Written By: Monica Short, Business Development Manager

  • Can you meet new compliance requirements?
  • Is your growth outpacing your resource capacity?
  • Are there roadblocks in your quality assurance or regulatory pathways?
  • Have changes to regulatory guidelines impacted your quality assurance and regulatory strategies?
  • Have you changed suppliers, vendors, or manufacturing processes recently?
  • Have you added a new line to your manufacturing facility?
  • Are you planning to move?
  • Are you prepared for your next inspection or audit?
  • Are you prepared for an unannounced FDA inspection?

Staying current in a fast-paced, regulated environment can be daunting.  You need to know your strengths and weaknesses.  How?  You can use a three step process to monitor for gaps, assess how critical those gaps are, and decide where, when, and how you can make improvements.

Step One – Understand your current state and future requirements or activity.  Review your current state.  Review your current activities, future requirements, desired states, targets, goals, and objectives.

Disinfectant Efficacy Testing

Step Two – Perform a gap assessment. Identify the gaps between where you are now and where you want to be.  Do internal or third party audits with an objective and unbiased lens.  Don’t sugar coat things.  Audit like your future depends on it, because it does.

Step Three – Make the necessary improvements to close the gaps. After you identify the gaps, prioritize and decide on the appropriate corrective and preventive actions.  Determine when you need to finish and what it will take to do the job.  You may want to enlist the assistance of an outside resource with a wide range of experience and knowledge.

Partnering with the right company can simplify the task of staying compliant. PSC Biotech brings professional services experience from more than 25 years of work with over a 1,000 clients in 31 countries.  PSC serves clients in regulated industries from globally recognized brands and multinational corporations to family-owned companies and start-up operations.

Our clients count on PSC to provide them best-in-class professional services to achieve and maintain compliance and deliver projects on-time and on budget.

  • Computer Systems and Software Validation (CSV)
  • Commissioning, Qualification, and Validation (CQV)
  • Audits, cGxP and Inspection-Readiness
  • Regulatory Affairs
  • Quality Assurance & Compliance
  • Environmental Monitoring
  • Engineering
  • Technical Writing
  • Project Management
  • Calibration and Thermal Mapping

How can we assist you, your team, and your organization? Contact PSC today! Let’s get started on toward Compliance success.

Software-as-a-Service, Use The Power Of The Cloud For Your Company

Software-as-a-Service, Use The Power Of The Cloud For Your Company

Written By: Andrea Salive, Business Development Manager

Question: when was the last time you left your house without your cell phone? Or asked your friend, hotel concierge or barista the Wi-Fi password (while socially distancing, of course)? Over the past few years, the world has rapidly evolved through technology and cloud implementation into nearly every activity we partake in. 

When it comes to your business operations and the fragmented, paper-based system that often creates more problems than good-why are you putting yourself behind the eight ball? Especially when it comes to the Life Science Industry, these organizations understand the criticality with following internal processes and how one simple mistake can result in major setbacks. A solution that an organization can significantly benefit from is a SaaS (Software-as-a-Service). A great example of a SaaS solution is the one and only PSC Software’s very own, ACE™ 

Electronic Quality Management System

Here are a few of the many benefits of this type of business solution:

1. SaaS products are software solutions that are hosted by a vendor or provider and are accessible via the internet. This means customers utilizing SaaS products have a huge advantage to the accessibility offered. Need your Quality Assurance Manager to sign off on a new policy? Not to worry, as they can simply complete this task from the tips of their fingers on their smartphone! This feature overall results in more efficient business operations from the get go 

 

2. For the most part, SaaS pricing structures are typically based off a subscription model. For example, when a company purchases, ACE™, they purchase named user licenses for their employees to access and utilize the system. Should that company rapidly start to scale and grow, ACE™ is scaling and growing every step of the way with it! A simple email or phone call to your PSC Software™ Manager requesting additional licenses can be taken care of in a matter of minutes! 

  1. Finally, because SaaS products are hosted by the vendorthis simply means that, for example given here,PSC Software™ is responsible for all system maintenance and software upgrades.  An organization utilizing ACE™ therefore eliminates passing along these additional tasks and responsibilities to their IT Department, once again, allowing for more efficient business operations.   

What are you waiting for- contact your friends at PSCSoftware.com today to see how we can implement these solutions for you!  

Quality Assurance (QA), Quality Control (QC) and Industry 4.0

Quality Assurance (QA), Quality Control (QC) and Industry 4.0

Written by: Shauna Clizbe, Business Development Manager

The biomanufacturing industry is currently undergoing a revolution in how it develops products. This paradigm shift is known as Industry 4.0. Industry 4.0 focuses on how to apply predictive modeling, data, analytics, artificial intelligence, and automation technology for the Digital Transformation of biomanufacturing manufacturing. 

Companies are investing in improved analytics, process control, and more of the elements of Industry 4.0.  Examples include using data and analytics from raw materials and bioproduction operations to improve the process with the goals of improving efficiency, lowering costs, and getting products to market faster. Quality Assurance (QA) and Quality Control (QC) are of utmost importance in the production of API’s, pharmaceuticals, and biopharmaceutical products, not just to meet Good Manufacturing Practices (cGMP) standards and regulatory requirements, but as a major tool in the Digital Transformation.  Processes and controls must be effective and enforced throughout your facility and process, from clean room operations to calibration of instruments and preventative maintenance in utilities systems.
Quality Control
While investing in better automation and analytics, biopharma manufacturers can take advantage of modular, pre-validated, and pre-tested single-use equipment, bioreactors, and chromatography systems that include built in electronic batch record (EBR) and manufacturing execution system (MES) functionality.  Integration of these complex systems with a QC and QA team can be a complex and sometimes difficult task.  Quality Control and Quality Assurance play inter-related and essential roles.  Creating successful QC and QA programs within the organizations can be streamlined by following some best practices;

  • Train your staff;
  • Documentation is key, especially in the age of Industry 4.0;
  • Perform at least an annual review of SOPs, policies, and programs;
  • QA and QC must enable your efforts, not disable them;

Be independent of the rest of the organization;

Creating QC and QA programs in any regulated industry is essential for success; contact PSC Biotech to learn about our Quality Services and Programs today!

What to Expect when Switching from Paper to an Electronic QMS

What to Expect when Switching from Paper to an Electronic QMS

Organizing and Uploading Current Documents  

 

System Capabilities  

Determine which workflows your new EQMS comes with. Controlled Documents, CAPAs, Deviations, Investigations, Out of Specification, Complaints, and Training are all critical workflows to have at your FDA-regulated company. If your new EQMS is pre-configured, ensure it comes with the workflows that you need now and ones you’ll need later, as you grow.  

Cloud-Based Software
User Permissions

Identify at least two persons in your organization as the System Administrators who will be in charge of adding new users and assigning their roles within the system. Who should be able to do what in your new system? This is an essential piece to your EQMS.  Quality Assurance and the System Administrator need to work together.  Identify the people for these roles and document your procedures accordingly. 

Validation and System Upgrades  

Does your new EQMS come validated or do you need to complete validation? Fully validated, ready-to-use systems will save you lots of time. Upgrades will always take place through the life of a system. It’s important to understand if upgrades are included in the price of your system, and who is responsible for the revalidation activities.  

Employee Training  

Once your new EQMS is implemented, train your employees.  Read any user guides that are provided with the system. Hopefully your new EQMS comes with an integrated Learning Management System!  If it doesn’t, track your training information elsewhere. Does your system come with a Sandbox instance that can be used for training purposes? Sandbox instances are extremely beneficial when training employees on new software. 

Our best advice is once you decide to switch to an Electronic Quality Management Systemstart your search, choose your system, and implement it as soon as possible. 

PSC Software’s, ACE Essentials™, comes with fully validated document control, quality management and learning management workflows all in a 21 CFR Part 11 compliant system that can be accessed on any device with internet connection. It can be implemented in as little as one week, as long as all of your documentation has been organized and is ready to be uploaded. We provide over 50 generalized, best practice documents to start-up your system. You can adapt these procedures to your process or upload your most current version to be approved. This system was built specifically for start-ups and small sized companies that are looking for a compliant, turn-key solution, at a cost-effective price. Reach out to PSC Software today to learn more.