ACE® Announces New Language Support

ACE® Announces New Language Support

We’ve added 6 new languages to the suite of PSC Software® applications. Adaptive Compliance Engine® (ACE® ) and AuditUtopia powered by ACE® now supports Spanish, French, Italian, Chinese (Simplified and Traditional), German and Japanese. PSC Software is dedicated to expanding access to its industry-leading eQMS and audit management software.

PSC Software continues to grow and add new features. As always, our users receive upgrades like additional languages, new modules, and the latest SOPs at no additional charge. We’re grateful for the global community of ACE users and strive to provide a seamless user experience for all.

To select a different language, please follow the below steps:

How to Enable System Languages in ACE®

 

1. Log in as a support user for the instance you want to enable languages for.

2. Go to System under the Administration wheel.

3. Go to System Configuration tab under Support User Settings on left menu.

a. Select desired languages that you want to enable.

4. Press Submit to save changes.

How to Change System Language in ACE®

(These languages can be changed once a support user has enabled language options per instance).

1. Go to System under the Administration wheel.

2. Go to General Configuration tab under Global Settings on the left menu.

a. Go to Internalization Settings and pick your desired System Language.

b. Users will only see languages options for the enabled languages done by the support user.

3. Press Submit at bottom of the page to save changes

 

4. If you wish for User Input Language to be enabled, you can toggle on the option under Internalization Settings and select desired language.

How to Change User Language in ACE®

1. Go to My Profile under user avatar.

2. Go to User Preferences under Profile Settings in the left menu.

 

3. Under Internalization Settings, select the desired System language.

a. For User Input Language, enable toggle and select desired language.

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software with particular specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries. During our 13 years, we have worked with both industry leaders and start-ups to ensure they reach their quality and compliance goals. Our mission is to develop our software to be intuitive to use, easy to learn, and flexible to fit each company’s needs. 

For more questions and support contact info@pscsoftware.com

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ACE® Mobile App is the latest addition to PSC Software®’s suite of eQMS solutions and is available for Apple iOS and Android devices. As an ACE customer, you can now download the ACE Mobile App and enjoy all the benefits of your eQMS software on your mobile device. Take your data with you wherever you go!

PSC Software, the leader in eQMS and Inspection Management Software Solutions, puts the power of ACE’s data into users’ hands. Access all the same innovative technology, such as ACE Docs®. All the same innovative technology, such as ACE Docs, ACE Analytics, and ACE Learning Management modules, are now in a mobile format. The intuitive user interface allows users to quickly navigate through different modules and features to view dashboards, complete tasks, sign documents, review items, and navigate through ACE with the same ease as the desktop version.

The ACE mobile app comes equipped with all the applications that let you access your configurable and fully compliant workflows. Track and manage scribe notes, track and manage requests, view interactive reports and analytics, access training & quizzes, and so much more, all at your fingertips.

PSC Software is excited to get this app into the hands of its thousands of current ACE, ACE Essentials, and ACE Inspection users.

ACE App Features

  • Full Accessibility to all ACE Modules
    • ACE Docs®, ACE LMS®, ACE Analytics®, ACE Inspection®, ACE Auditor®, ACE Sign®, ACE Validation®, ACE PLM®, ACE Docs®, ACE Risk®, ACE Regulatory Profiles®, ACE Assessments, & more!
  • Single Sign On Support (SSO)
  • E-Sign Capability
  • Horizontal and Portrait Viewing Modes
  • Zoom Functions
  • Same user-friendly format at desktop versions
  • Switch between ACE Instances at the click of a button
  • And much more!

 

ACE sign

 

“This is a great app addition to the ACE eQMS platform. Works for my needs as I can sign, complete training, etc. as needed on the go.” – ACE User

The ACE App is free to download and is available in the Apple App Store and Android Google Play store. Search for “ACE Adaptive Compliance Engine” in the store or find it in the medical category.

 

You can learn more about ACE by visiting https://pscsoftware.com/software/ace/ or contacting us at info@pscsoftware.com.

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What is an eCTD submission?

The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of modules, sections, and documents to be used by an Applicant for a Marketing Authorization for a medicinal product for human use agreed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Records GMP compliance

While the table of content is consistent with the CTD, the eCTD also provides a harmonized technical solution to implementing the CTD electronically. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone, and with the file’s integrity guaranteed by the MD5 Checksum.

While most applicants opting for paper submission can opt for a CTD submission, most of the regulatory authorities including the United States (US Food and Drug Administration or USFDA) and Europe (European Medicines Agency or EMA) require mandatory submission of almost all applications in the eCTD format. So, if you are an applicant registering a product, be it a pharmaceutical, biological, medical device, or veterinary product, the eCTD format will be mandatory for regulatory submission.

The eCTD submission is composed of the following:

  • Directory structure

  • XML eCTD instance

  • Content file

This FDA guide gives detailed eCTD backbone guidance to applicants for file structure, file names for an eCTD submission as well as acceptable file formats for Module 2, 3,4, and 5 for USFDA, while Backbone Files Specification for Module 1 gives detailed structure and acceptable file formats for regional information for USFDA.

One of the examples of Module 3 backbone  is indicated below:

The common formats that can be included in an eCTD submission are:

 

  • Narrative: Portable Document Format (PDF)

  • Structured: Extensible Markup Language (XML)

  • Graphic: Whenever possible, use PDF.

Regulatory applications applicable to the eCTD submission:

For submission to USFDA: The eCTD is the standard format for submitting applications, amendments, supplements, and reports for drugs and biological products to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) respectively. The eCTD is required for:

    • Certain investigational new drug applications (INDs)
    • New drug applications (NDAs)
    • Abbreviated new drug applications (ANDAs)
    • Certain biologics license applications (BLAs)

It is also important to note that the electronic submission requirements do not apply to submissions such as expanded access INDs and protocols for individual patients, including for emergency use; expanded access INDs and protocols for intermediate-sized patient populations; and expanded access treatment INDs and protocols and these can be submitted in the CTD format.

For submission to EMA:

The eCTD format is mandatory to use for all submission types related to Marketing Authorization for products within all EU procedures i.e.

  • Centralized procedure: human medicines containing a new active substance to treat:
    • human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
    • cancer;
    • diabetes;
    • neurodegenerative diseases;
    • auto-immune and other immune dysfunctions;
    • viral diseases.
    • medicines derived from biotechnology processes, such as genetic engineering;
    • advanced-therapy medicines, such as gene therapy, somatic cell therapy, or tissue-engineered medicines;
    • orphan medicines (medicines for rare diseases);
    • veterinary medicines for use as growth or yield enhancers.
  • Decentralized procedure:
    • Mutual Recognition Procedure
    • Stepwise introduction for National Procedures.

The eCTD format ensures an efficient regulatory submission electronically, easier data exchange between the applicant and regulatory authority, and document management for the applicant through design and structure.

PSC Biotech® has in-house regulatory expertise and offers expert guidance and support with respect to managing your global regulatory submissions and drafting the eCTD Modules (Module 1 to Module 5) as well as navigating all the regulations pertaining to your product.

PSC also offers regulatory services in terms of drafting a regulatory framework and strategy, formatting, and publishing the eCTD Modules. Contact PSC Biotech to manage your submissions efficiently!

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On-site and Remote Inspection Management

Regulatory inspections can be some of the most intense and stressful activities on a highly regulated company’s path to commercial success. Learn what to expect from an on-site or remote audit, how to prepare to eliminate errors, and avoid infractions. You will need to provide complete and accurate responses to the inspector’s questions and requests while maintaining effective internal communication, tracking requests, delivering documentation, and logging internal notes — all in real-time. 

In this whitepaper, we identify the keys to a successful audit and recommend inspection management tools to keep your company compliant. Inspection management tools can help with:

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With a well-prepared inspection management system, your company will be ready to navigate inspections with ease.

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Adaptive Compliance Engine® (ACE®)

Trusted Highly-Configurable Enterprise Quality Management System

ACE® allows companies like yours to adapt and grow to meet your evolving quality management needs, without coding. ACE® is a highly configurable, workflow-based software that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With all future updates being included at no additional charge, you will be able to utilize new functions immediately. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while staying 21 CFR Part 11 compliant.

ACE Inspection® allows companies to streamline regulatory inspections by tracking all requests and logging notes in a single platform. Real-time updates and in-system notifications ensure that your team is responding to requests efficiently. With ACE Inspection® you’ll instantly have all the information you need to please your inspector at every turn.

ACE Inspection® software as a service is a cloud-based technology and can be accessed anywhere with WiFi or data on all your devices. Hosted at SOC I, SOC II and ISO 27001 certified global data centers, each release of ACE Inspection® software as a service is IQ and OQ qualified at no additional charge to reduce your validation efforts.

 AuditUtopia® captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life science companies worldwide. With AuditUtopia®, you can streamline your inspection process, improve response time for requests and lead end of the day meetings. Many organizations choose AuditUtopia® as the center of their inspection team to seamlessly streamline group efforts to improve response time for inspection requests. 

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PSC Biotech® welcomes Korey Fleck as Vice President of Solution Architects as of September 12, 2022. Korey comes to PSC Biotech with over 20 years of experience servicing the Life Science Industry. Having experienced various roles in Distribution, Manufacturing and Strategic Sourcing, Korey has a very well-rounded skillset in this industry to help meet our customer’s needs.

As a business development executive, Korey brings skills and experiences that align well with PSC Biotech’s priorities – spearheading and executing time-sensitive clinical and commercial manufacturing initiatives for global pharmaceutical, biotechnology, and medical device organizations. His diversified background, entrepreneurial spirit, and agile adaptivity allow Korey to deliver operations leadership, sales management, strategy, and innovation that optimize projects of all sizes, complexity, and duration for success.

Korey’s prior experience includes serving as an executive managing the production and distribution of Covid-19 Response supplies internationally. 

Korey has extensive experience in the sterile (aseptic) and non-sterile controlled environments space, offering solutions for FDA-regulated companies.

 

Justin Jay COO

A leader in the life science industry with a track record of success, Korey’s experience will make a significant contribution to helping PSC Biotech work effectively under aggressive timelines, challenging logistics, and complex requirements.

PSC is delighted for Korey to join the management team alongside our other corporate officers.

Since our inception, PSC Biotech has served as a strategic partner to emerging and established life science companies, all in an effort to help bring their life-saving products to market. Learn more about what PSC Biotech’s professional service solutions can do for your company.