Apyx offers easy to use CTD templates to automate and help expedite the submission authoring and publishing process as well as Validation Templates to reduce the time and cost of validating a newly purchased EDMS or electronic submission publishing system.
CTD Authoring Templates/SmartStart® CTD Templates
Apyx's CTD templates are designed to assist you in writing documents that fully comply with ICH E3 granularity standards and with the FDA’s Granularity Annex to the ICH standards. They enable creation of documents that are well structured, consistent, reusable (across regions), high quality and submission ready. Apyx CTD templates are based on the Microsoft Word platform. Apyx has over 100 individual CTD templates across all five modules.
Annotation Manager®
Annotation Manager is an authoring environment that enables creation, review, approval and publishing of annotated and proposed Package Inserts and other labeling for new compounds. It makes it easy to author a PLR compliant package insert, manage annotations for the Annotated PI and create all required PI-based labeling.
Annotation Manager provides functionality to:
- quickly and easily insert annotations along the right hand side of the document
- automatically re-sequence annotation numbers throughout the document, regardless of the number of edits and new annotations
- show/hide line numbers down the left hand side of the document
- create proposed (clean text) labeling directly from the Annotated PI
- include special characters in documents in a rendering-friendly way which facilitates document publishing
- easily create tables within the document
- integrate with any Document Management and/or Publishing system
Annotation Manager can be used with or without SPL Manager. When combined with SPL Manager, Annotation Manager delivers intuitive, seamless conversion from text based labels to SPL.
SPL Manager®
SPL Manager enables creation of compliant SPL formatted labels within your existing package insert. SPL Manager uses Microsoft Word menu items and simple forms that allow you to describe, in non-technical terms, the content of your document as it relates to the SPL guidelines. SPL Manager does not add complex layers of document management or process changes, enabling you to focus on authoring a document instead of learning a new tool or redefining your document management processes.
It can work in conjunction with Annotation Manager or as a stand-alone SPL conversion tool. SPL Manager extends Annotation Manager’s author-focused functionality by enabling Package Inserts created with Annotation Manager to be easily converted from text to Structured Product Labeling (SPL) format using the same Microsoft Word document.
SPL Release 4 handles Drug Establishment Registration and NDC Labeler Code submissions in addition to the Product Label.
Apyx also provides outsourced conversion services.
Validation Templates
Apyx provides validation templates for the most common documents related to GCP systems validation. Apyx is the only company to offer these templates, which enable rapid creation of the following documents:
- Systems Validation Master Plan
- User Requirements Specification
- Technical Requirements Specification
- Signature/Initials Correlation Sheet, Traceability Matrix
- Test Script
- Error Resolution Log, and
- Systems Validation Summary
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News & Events
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.