Hello and welcome to the January 2024 edition of the Qualio+ newsletter. You’ll find lots of important information throughout this article on what changes have been made to the Qualio+ content, new training that is being provided by the Qualio+ Team, as well as useful snippets from recent webinars and blog posts to answer any quality-related queries you may have. Check out the following video for more information and as always, let the team know if there’s anything we can help you with.
Meet the Qualio+ Team
 | JERRY ADATSI Manager, Quality Services |  | LOLA FURLONG Senior Quality Specialist |
 | SUMATHA KONDABOLU Senior Quality Specialist II |  | MOLLY CALVEY Senior Quality Specialist |
 | JASON MARCH Senior Quality Specialist |  | CASEY WISE Quality Specialist |
Table of Contents:
Updated Qualio+ Content
Review the “Update Details” column for specific updates, or request a strategy session with your Quality Specialist for further information using the Qualio+ Customer Request Form.
Document | Impacted Customer Profile | Update Details |
Quality Manual | SaMD & HW | Added section on Person Responsible for Regulatory Compliance to comply with Article 15 of EU MDR (2017/745). Updated section on Design History File and ISO Technical File to include UK MDR 2002 requirements. HW only: added new section on Planning of Product Realization to align with ISO 13485:2016 clause 7.2. |
General Change Procedure | SaMD & HW & Pharma | Added the following information on Administrative Changes under the Types of Changes section to align with the Quality Manual, where administrative changes are mentioned: Documents needing administrative corrections (e.g. typos, punctuation, etc.) do not need formal review and approval through the change control process and can be updated and approved by the same individual. Note: Ensure the Signature Matrix Template allows admin changes to be approved by the same individual. |
Document Control | SaMD & HW & Pharma | Added the following instructions on how to manage attachments and forms in Qualio: Forms shall be reviewed as part of their parent SOP or WI reviews. Version control will have to be manually checked/updated in the source document. |
Control of Quality, Regulatory and Product Records | HW | Added a new section on Control of Quality Documents which discusses the control of procedures, work instructions, policies, the Quality Manual, validation protocols and risk documents. Additional information discussed in this section include the signature matrix, periodic reviews and document storage. |
Analysis of Data | SaMD & HW | Added clinical data as another source of data that is recorded, compiled and analyzed to comply with UK MDR 2002 requirements. |
Adverse Event, Vigilance and Incident Reporting | SaMD & HW | SOP title revised to Medical Device Reporting, Vigilance and Incident Reporting to align with ISO 13485:2016, MDSAP, EU MDR (2017/745), and UK MDR 2002 terminology. Added sections on Australian Incident Reporting Requirements to comply with TGA Regulations 2002. |
Design Controls | SaMD & HW | Purpose and Procedure sections updated to remove content about the procedure only applying to Class II devices and higher. The SOP also applies to certain Class I devices. Clarification provided that Phase Reviews are captured in Design Review Records. |
Production Identification, Traceability and Unique Device Identification (UDI) Management | SaMD & HW | Added additional context to UDI creation and management for SaMD products and additional content around UDI in the EU, specifically Basic UDI. |
Labelling and Packaging | HW & Pharma | HW only: Added the following specific label requirements for the EU: Where applicable, the label must include an indication that the device contains or incorporates:
Added the following specific label requirements for the UK: The label must indicate that device is for 'single use', 'custom made' or for 'clinical use only' if appropriate;
An additional section was added for the labeling translation process in conformance with UK MDR requirements: Under the scope of UK MDR, information contained on a label needs to at least include English and may also include other languages, as needed. If the Instructions For Use (IFU) are not in English, the label must have a clear statement in English indicating the language(s) that the IFU are given in. Self-Test IVD devices must include a translation into the official language of the member State of the Community in which the device reaches the final user.
Pharma only: SOP was updated in line with the following regulations: FDA 21 CFR 210/211/600/1270/1271, MHRA, TGA (PIC/S GMP Guide), EU (Eudralex Vol 4), Health Canada and GCP. |
Out of Specification (OOS) | Pharma | This SOP was updated to align with the MHRA's OOS/OOT presentation which is considered by the FDA and the EMA to be the gold standard for conducting OOS/OOT investigations for medicinal products. The SOP also aligns with the FDA's updated 2022 guidance for industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. Australian and Canadian requirements were added to the procedure. |
Laboratory Controls | Pharma | Added the following Qualified Person responsibilities to comply with EU/UK requirements: The Qualified Person who certifies a batch for sale should ensure that:
The SOP was updated to meet the requirements of Europe, the UK, Australia and Health Canada. |
Stability Program | Pharma | Added new section on Clinical Trial Phase Specific Stability Requirements. |
Management of Supplier Files in Qualio | SaMD & HW & Pharma | Updated instructions on how to export, archive & unarchive suppliers as well as audit trail entries to align with updates made to the Qualio software tools. |
Signature Matrix Template | All | Added the following note under the matrix in line with changes made to the General Change Procedure: per SOP-XX General Change Procedure, administrative corrections (e.g. typos, punctuation, etc.) do not need formal review and approval through the change control process and can be updated and approved by the same individual. |
*SaMD = Software as a Medical Device
*HW = Hardware Medical Device
*Pharma = Pharmaceutical Product
New Content
New ISO 27001 Content
Employee Training and Development Policy
Document Management and Control Policy
Cryptography and Cryptographic Key Management Policy
Network Security Policy
Cable Security Policy
Good Practice for Digital and Data-Driven Health Technologies SOP
Register of Data Processing Activities (GDPR Inventory) Template
Note: the ISO 27001 content was recently revised to align with the 2022 version of the standard.
New Clinical Content
Trial Master File Management SOP
Clinical Data Management SOP
Clinical Trial Risk Management SOP
Archiving of Clinical Trial Data and Essential Documentation SOP
Case Record Form (CRF) Design SOP
Trial Closure SOP
Preparation of a Study Specific Randomization, Blinding and Emergency Unblinding Procedure SOP
Clinical Evaluation Report Template
Case Record Form Approval Template
New ISO 9001 Content
Release of Product and Services SOP
New SaMD Content
Software Validation Procedure (IQ/OQ/PQ) SOP
Qualio+ Training Sessions
Training on quality-related topics is always beneficial for understanding how to use your Quality Management System in the most efficient way possible. Below is a list of the training currently offered by the Qualio+ Team, with some exciting new additions since the last newsletter was released:
NEW - Combination Products: Regulatory Approach and cGMP Requirements
NEW - Internal Auditor Training
NEW - Complaint Handling
NEW - Device Development Pathways
NEW - Software Validation
Supplier Management
Effective SOP Writing
cGMP Training - History and Practice
Intro to Management Review
Corrective and Preventive Action (CAPA)
Good Documentation Practices
How to Manage Internal and External Audits
12 Pillars of a Quality Management System
Audit Preparation
Design Controls - Requirements from ISO 13485 and FDA
An Overview of ISO 13485 and FDA Requirements
Risk Management
Supplier Management - Device
Upcoming Webinars
Date | Details | Registration Link |
February 27, 2024 | Feb ‘24 Launch Train Customer Webinar | |
March 5, 2024 | Risk Management - Ask The Expert with Peter Sebelius | |
March 19, 2024 | Software as a Medical Device (SaMD) - Ask The Expert with Christian Kaestner | *Registration link coming soon* |
March 27, 2024 | Tips & Tricks: Document Creation Options |
Snippets from recent webinars with useful information
Interested in knowing the most common mistakes in risk management according to Peter Sebelius? View the snippet below of the risk management webinar held in December highlighting the approach all companies should be taking when performing risk management activities.
Ever wonder what systems are usually missed when setting up a pharmaceutical quality system in compliance with ICHQ10? Casey Wise provided an insight during our recent Therapeutic Quality Excellence webinar which will be of great interest to our pharmaceutical customers.
Qualio+ on LinkedIn
Do you have a quality-related topic or query that you’d like the Qualio Plus Team to discuss on the Qualio LinkedIn page? If so, we’d love to hear from you through our Customer Request Form (select LinkedIn Video Topic Suggestion when selecting the desired service form the Qualio+ Team). In the meantime, check out Jason March’s short video on Quality tips for effective supplier management below.
Recent Blog Posts
The Qualio Blog is constantly being updated with new content for our customers. Here are a few of our recent favorites for you to explore:
Top pharma conferences in 2024 guide by Jerry Adatsi
How much does ISO 9001 certification cost? by Lola Furlong
21 CFR Part 820: the complete overview by Sumatha Kondabolu
PMA meaning: understanding FDA pre-market approval by Jerry Adatsi
QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained by Sumatha Kondabolu
Regulatory Updates
Updates to regulations, standards and guidance documents happen on a frequent basis. Knowing what’s been updated and when the changes occurred can be a challenge. So we’ve put together a list of useful resources to keep you informed on industry updates.
Search for updates to guidance documents in the FDA Guidance Documents Database.
The FDA has published a searchable repository containing all of its documents related to pharmaceutical quality: FDA Pharmaceutical Quality Documents.
The FDA Group Insider Newsletter provides the latest news on FDA-regulated industries, as well as highlighting and providing analysis of regulatory changes.
Keep up to date with the FDA Medical Devices News and Events webpage.
Subscribe to the various European Medicines Agency’s (EMA) RSS feeds to stay up to date with the latest EMA news and features: EMA PSS Feeds.
The EU Medical Device Sector - Latest Updates web page includes any updated guidance documents from the Medical Device Coordination Group.
The Stat Health newsletter is a great resource for providing industry updates, in particular on digital health.
Subscribe to the Pharmaceutical Online newsletter for updates on pharmaceutical manufacturing and packaging.
The MHRA publishes new guidance documents and information for industry through its website.
