AuditUtopia® vs. ACE Inspection® Management Software

AuditUtopia® vs. ACE Inspection® Management Software

Undergoing inspections and audits is a harrowing experience. Before the FDA, EPA, or other regulatory agency inspectors visit, you need to form an Inspection Team within your company. When the inspector arrives, making a good impression sets a positive tone because the company is efficient, friendly, and meticulous. What happens when the inspector starts making requests? The most efficient and effective teams use Inspection Management Software (IMS).

What is Inspection Management Software (IMS)?

Inspection Management Software (IMS) is the alternative to using a combination of video calls, spreadsheets, logs, record systems, document generation software, and online document sharing platforms. Efficiency for fulfilling inspector’s requests is immensely improved by using a single software system to log, track, generate, and produce reports.

History of Inspection Management Software

AuditUtopia® was the first inspection management software created in 2009 by PSC Software™. AuditUtopia® is an out-of-the-box solution for effective, streamlined management for inspection events. It is the highest-rated audit software product compared to similar products on Capterra.

AuditUtopia® supports your company by providing a single platform to:

    • Track and manage inspections
    • Log inspection and scribe notes
    • Enter and track requests
    • Send notifications
    • Real-time team communication
    • Configurable permissions
    • Generate charts and graphs
    • Export reports
AuditUtopia

 “Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia® has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia® and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”
– Former Food and Drug Administration Commander

The Evolution of IMS – Beyond the Audit Room

After the fastest vaccine generation and rollout in US history, the need for agile management of pharmaceutical and biotechnology regulatory affairs is greater than ever. PSC Software™ is announcing the new inspection management system essential – ACE Inspection®. This new addition to the Adaptive Compliance Engine (ACE™) extends compliance inspection and audit management beyond the investigation day. ACE™ is an electronic quality management system (eQMS) for end-to-end quality and validation management. Enhance your audit readiness by integrating your day-to-day quality management processes with your inspection management software. On top of AuditUtopia®’s features, ACE Inspection® adds:

  • Pre-validated installation and operational qualification (IQ/OQ)
  • FDA-mandated 21 CFR Part 11 compliant electronic signatures
  • Application Programming Interface (API) to integrate other software or cloud documents
  • Single Sign-On (SSO) support
  • Interactive charts on the dashboard
  • Enhanced chat and scribe
  • Scribe record tagging, which integrates into ACE™
  • In-system notifications
  • Coordinates with ACE SuperVision™ for Google Glass Enterprise 2.0
  • Form Auto-Fill
  • Workflows for multiple inspection types (e.g., FDA vs. EHS inspections)
  • Configurable workflows for each record type (e.g., Inspections, Requests, SME Interviews)
  • Multiple report templates that pull metadata from the system (e.g., Audit, Management and Inspection Summary reports)
  • Event management (due dates, scheduling, reminders)
  • Audit resolution and CAPA follow-up

In Summary

Choose AuditUtopia® if you want a pre-configured inspection management software to use during audits. Leveraging industry-leading features that allow teams to take scribe notes, manage requests, and create reports, AuditUtopia® streamlines inspection events. It is an unmatched economical approach to comprehensive inspection management. To extend your accuracy and preparations, choose ACE Inspection® because it encompasses processes beyond inspection day events. ACE Inspection® brings you broader capabilities with configurable workflows that allow teams to track and manage daily summary notes, near misses, and observations. PSC Software™ gives you the choice of inspection management software solutions.

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

Related Articles

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...

The Importance of Computer Systems Validation

The Importance of Computer Systems Validation

PSC Biotech can provide you the highest quality CSV services on any scale. 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 computer systems validations to ensure that your systems do what you intend, maintain data integrity, and meet regulatory agency requirements.

What is the importance of Adverse Event Reporting?

What is the importance of Adverse Event Reporting?

What is an Adverse Event Reporting System (AERS)?  The Adverse Event Reporting System (AERS) is a computerized information database designed to support the life sciences, healthcare, biotechnology & FDA agency post-marketing safety surveillance program for all...

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 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
What is the importance of Adverse Event Reporting?

What is the importance of Adverse Event Reporting?

What is an Adverse Event Reporting System (AERS)? 

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the life sciences, healthcare, biotechnology & FDA agency post-marketing safety surveillance program for all approved drug and therapeutic biologic products. Regulatory authorities and agencies use AERS to monitor new adverse events and medication errors that might occur with these marketed products. Reporting of adverse events from the point of care is voluntary. FDA receives some adverse event and medication error reports directly from health care professionals such as physicians, pharmacists, nurses, and consumers (such as patients, family members, lawyers and others).

Organizations operating in the healthcare domain must have processes and procedures in place to meet the AERS regulations set by authorities

Why is an AERS important? 

Adverse Events Reporting System is crucial for detecting, processing & reporting adverse drug & supplement-associated events. Thus, reporting via an AERS is fundamental to detecting subject safety issues and mitigate the relevant risks with planning. This is the reason healthcare and life sciences companies are required to clearly state the method by which the adverse events will be monitored & reported. This also includes stating the provisions to ensure safety, care and medical support for those experiencing unfavourable signs & symptoms during a clinical trial.

How does AERS work?

Safety Database 

A safety database is used to manage safety reports incoming from multiple research & study centres where the clinical trials are conducted. This database or repository of all the adverse cases can be analyzed together to flag potential trends amongst the cases. The review and analysis of the safety of a given healthcare product is given by the safety committee, which is composed of a group of experts in the field.

Recording Adverse Events 

To efficiently evaluate safety information pertaining to a clinical trial, the safety reports of an organization must satisfy the reporting threshold set by regulatory agencies like the FDA. In the case of a large volume of independent adverse event reports that lack context and clarity, evaluating the safety information becomes impossible.

Thus, to maintain the integrity of the safety process and protect human counterparts, the following things must be considered while recording an adverse clinical trial event;

  • Severity or intensity (mild, moderate or severe)
  • Study intervention relationship
  • Action taking as per the study intervention
  • Outcome of the adverse event
  • Whether the adverse event is serious or non-serious

The above AERS compliance requirements determine the reporting procedures that must be followed.

Need adverse event reporting system planning?

PSC Biotech will assist you in creating a strategic roadmap for determining what data should be collected and what processes need to be in place to ensure compliance with regulations, including definitions and approaches to define the roles, responsibilities, processes, forms, the communication of adverse events and the follow-up activities to ensure that complete information is obtained.

Get in touch with PSC Biotech today!

What is the Significance of Electronic Document Management Systems in the Life Science Industry?

What is the Significance of Electronic Document Management Systems in the Life Science Industry?

Accurate record management is a crucial operation for the organizations in Biotechnology, Life sciences, Pharmaceutical and Medical Equipment domains. The document content is growing enormously and manual sorting of the records makes it tedious & prone to errors. This is where Electronic Document Management Systems comes into the picture. Organizations in the life science industry utilize cloud-based document management software to create, modify, and maintain documents to ensure accuracy, fast retrieval and audit.

What are the challenges posed by manual document management?

Manual document management has become obsolete in the life sciences industry due to multiple challenges and inefficiencies. Some of them are;

Tedious Team Collaboration

Manual preparation of the documents is a time-intensive process that requires collaborative work. If the workflow is not streamlined, errors and delays often occur. This makes the records less reliable than automated records.

Inherent Risks of Manual Document Management

The manual process of document management leaves it prone to many human errors. This might include losing a critical document, wrong filing, erroneous labelling and misinterpretation of information. This also points to poor revision and update procedures as there are no reminders for the human users to do so.

Tracking Changes is Difficult

Keeping a track of all the versions and the relevant changes in them is a big challenge for life science companies that are using manual document management systems. This sometimes poses regulatory challenges due to the unavailability of the latest version of the document. A document might be required beforehand before its revision date has arrived and that becomes a challenge!

Logistical Challenges

Physical documents require dedicated and secure storage space which maintain optimum environmental parameters. Crucial records are often stored in fire-proof and waterproof cabinets that require more space. Moreover, access to the storage has to be monitored for security & integrity of the data.

How does an Electronic Document System mitigate the above challenges?

A cloud-based Electronic Records Management system is fast, reliable, secure and efficient. Following are its benefits in the life sciences industry.

Cloud Storage and Automation

An Electronic Document Management system eliminates the need for physical document processes. Automated uploads, scanning & recognition save tonnes of labour and mistakes in maintaining crucial data about the patients.

Seamless Information Retrieval

Most advanced EDM systems come with advanced search and record retrieval features. From simple string search for the document title to page controls and tags, EDMs allow access to the latest version of any given document at any time.

Version Tracking & Security

Electronic Document Management Systems keep a track of all the versions of a document with time stamps. Moreover, watermarks can be placed on the documents as per their usage. For. e.g. Confidential, For Training, Controlled Copy, Uncontrolled Copy, etc. This also makes the process of updating documents much easier.

Regulatory Compliance

State-of-art Electronic Document Management systems come enabled with all the regulatory mandates. For instance, PSC Biotech’s EDM software is compliant with EU Annex 11, ISO, MHRA & WHO. The teams can access features like audit trails, e-signatures and 2-level authentication for every document.

Need a Reliable EDM Software for Your Life Science Company?

For over ten years PSC Software™ has provided cloud-based document management software for life science companies around the globe. If you would like to know how we can help your company optimize record management and streamline your business, get in touch with us today!

 

Auditing Services – Data Integrity

Auditing Services – Data Integrity

Data integrity has become crucial to compliance for regulated life science companies.   Data Integrity assures the completeness, consistency, accuracy, authenticity, timeliness, and reliability of your data.

Whether your company is a biotechnology startup, pharmaceutical company, blood bank, gene therapy research institute, medical diagnostics facility, food and beverage corporation, you rely on digital data. Data Integrity shortcomings can lead to increased compliance costs to remediate the FDA citations, Warning Letters, and even delay your product approvals.

  1. Experts recommend that your data integrity program follow the ALCOA+ principles to achieve and maintain data integrity.
  • Attributable to the person, system, or data generating the data: What is the source of the data? Who did the data collection and performed the analyses?
  • Legible, traceable, and permanent: Is the data readable and understandable? Is it stored in a durable medium?
  • Contemporaneous: Where and when was the data created? Was it recorded as it was generated or observed?
  • Original: Is it an electronic record or metadata? Have the original records been preserved? Are they easily retrievable?
  • Accurate: Is the data error-free? Has it been maintained, updated and modified well?
  • Complete: Is all data available? Has anything been deleted?
  • Consistent: Has the data been chronologically arranged? Are there date and time stamps on the records?
  • Enduring: Will the data last even after 20 years? Will it lose readability after a long period of time?
  • Available: Can the data be accessed throughout its lifetime?
  1. Assess your systems for situations that might lead to data security breaches or compliance issues. Implement proper controls.
  2. Identify your products and processes with electronic data capture, such as automated HPLC systems, etc., high rates of Out Of Specifications (OOSs), and restrictive stability specifications. Implement appropriate controls for your high risk systems.
  3. Document results, observations, and discrepancies carefully. Pay special attention to orphan data or excluded data.
  4. Develop and implement corrective and preventive action (CAPA) plans to eliminate undesirable situations and non-conformities, and to improve data integrity.

Our team at PSC Biotech™ understands the data integrity responsibilities and provides audit and remediation services for data integrity.

Our insightful audit reports promote effective data integrity and record management strategies, and encourage data protection and privacy. We ensure our clients meet the standards set by the U.S. Food and Drug Administration (FDA), the European Commission (EC), an regulatory Agencies throughout the world. Whether you do research and development, clinical trials, quality control, manufacturing, data management or inspection, PSC Biotech™ can help you establish, evaluate, and improve your data integrity.

Convinced yet? Give us a call or visit www.biotech.com for more information.

Stay In the Loop - Join Our Newsletter