Author: Support ABCI Consultants

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QMSCAPA Update

QMSCAPA 2.35.4

Monitoring and Measuring Supplier Quality Performance

Over the years, QMSCAPA has integrated structured methods to manage purchasing processes, ensuring compliance with the standardized practices outlined in AS9100 and other ISO 9001-based Quality Management Systems.

QMSCAPA version 2.35.1 delivers enhancements to purchasing processes, ensuring greater alignment with ISO 9001 requirements. The specific improvements are outlined below to support consistent application across all procurement activities.”

  • Receiving and inspection records are maintained to track Key Performance Indicators (KPIs) for all ‘primary’ products purchased. These records provide measurable data on product quality, conformity, and supplier performance.
  • In addition, QMSCAPA version 2.35.1 introduces new reports that evaluate Supplier On‑Time Delivery (OTD) performance. These quality reports are automatically generated from the RFQ and Purchase Order (PO) forms, and are directly linked to purchasing activities, receiving inspections, and KPI analysis. This integration ensures that supplier performance metrics are consistently documented, traceable, and aligned with ISO 9001 requirements.

Why Supplier Quality Performance Matters

Compliance with Standards

  • AS9100 Rev D emphasizes rigorous supplier quality management to guarantee aerospace products meet safety and regulatory requirements.
  • ISO 9001:2015 Clause 8.4 requires organizations to control external providers to ensure purchased products conform to requirements.
  • Product Integrity & Safety
    • In industries like aerospace, a defective or late component can compromise safety, reliability, and compliance. Monitoring supplier performance ensures that purchased items consistently meet specifications.
  • On‑Time Delivery (OTD)
    • Timely delivery is a key performance indicator (KPI). Late deliveries can disrupt production schedules, increase costs, and delay customer commitments. Measuring OTD helps organizations identify weak points in the supply chain and take corrective action.
  • Customer Satisfaction
    • AS9100 Clause 9 requires monitoring and measuring QMS performance, including supplier contributions, to ensure customer satisfaction. Reliable suppliers directly influence the organization’s ability to meet customer expectations.
  • Risk Reduction
    • Poor supplier performance can lead to defective components, delays, and even recalls. Tracking KPIs like quality and OTD reduces risks and strengthens supply chain resilience.
  • Continuous Improvement
    • Both AS9100 and ISO 9001 emphasize continual improvement. Supplier performance data provides insights for corrective actions, supplier development, and strategic sourcing.

Practical Benefits of Monitoring Supplier KPIs

  • Traceability: Ensures records of supplier performance are available for audits.
  • Decision-Making: Data supports supplier qualification, re‑evaluation, or disqualification.
  • Efficiency: High‑performing suppliers improve workflow and reduce waste.
  • Partnerships: Encourages collaboration with suppliers to improve processes and meet shared goals.

Recording Supplier KPI in the Purchasing Processing module

Using the QMSCAPA application, go to the text menu located at the top of the window. In the image below, select Browse Logs, and then choose Purchasing Processes to view related records.

  1. In the RFQ/Purchase Order table window (below), KPI completion status checkboxes appear at the top‑right corner.
  2. The bottom‑right corner displays two Supplier OTD reports by date range—one for all records and one for the highlighted supplier.
  3. Open the RFQ/Purchase Order record by double-clicking the selected record or clicking on the [Blue Edit] button.
  1. In the image below, go to Tab 3) Product/Services and select a Product Item record as the ‘Primary KPI Product’ via the table scroll bar.
  2. With the ‘Primary KPI Product’ highlighted click on the the [Copy Item to Tab 5) Primary KPI] button.
  3. To complete the ‘Receiving & Inspection’ record go to Tab 4) Ship To + Receiving + Inspection
  1. To measure On‑Time Delivery (OTD), enter the Receiving Person’s ID and the Date Received in the fields shown below.
  2. To record the Inspection, enter the Inspection Person’s ID and the Date Inspected in the fields shown below.
  3. Navigate to Tab 5: Primary KPI and enter the required KPI data into the designated fields.
  1. To measure the Key Performance, enter the Author’s ID, Label Set ID, and select a Product Id (if not previously recorded) in the fields shown below. Entry of a Batch Label or Label Number, as well as the actual batch or number, is optional.
  2. The Quantity Labels are determined by the Label Set ID selected in the section above.
  3. The Quantity values in QM# fields (QM1 through QM4) must be entered by the Author of the Record. QM5 is automatically computed.
  4. The KPI Record Copied to Purchasing Quality Measurements checkbox will automatically appear as checked once the KPI record has been successfully copied from the Purchasing Process table to the Purchasing Quality Metrics table.
  5. Enter the Reporting Date and Notes for the Records, then check the KPI Sampling box to add KPI data to the Purchase Order KPI and Purchasing Quality Metric tables.

In summary: Monitoring and measuring supplier quality performance, including on‑time delivery, is not just a compliance requirement under AS9100 and ISO 9001—it is a strategic necessity. It safeguards product integrity, ensures customer satisfaction, reduces risk, and drives continuous improvement across the supply chain.

Copying Purchase Order & Supplier KPI Data to the Purchasing Quality Metrics table

Supplier KPI data may also be recorded directly in the Purchasing Quality Metrics table or copied from the Purchasing Processes table. This flexibility ensures accurate tracking and alignment with purchasing performance records.

  1. Getting Started: From the QMSCAPA top‑of‑window text menu, select Quality Measurements, then choose Purchasing Quality Metrics, as illustrated in the image below.
  1. Click the [+ Copy KPI Data from PO] button to copy the Purchasing KPI data, as shown in the image below.
Copying PO KPI Records to the Purchasing Quality Metrics table linked to the Quality Performance Dashboard
  1. Copy the KPI Record
    • Click the [Copy Selected PO with KPI Record to Purchasing Quality Metrics Table] button to copy the highlighted record.
  2. Filter Requirements
    • The Supplier RFQ/PO Table is filtered by the Primary KPI data entered in the Supplier RFQ/PO Form.
    • The following fields must be completed:
      • Label Set
      • Product Name ID
      • Reporting Date
    • In addition, the KPI Sampling Completed checkbox must be selected.
  3. Close the Window
    • To exit and return to the Purchasing Quality Metrics Table, click the [Go to Quality Metrics Table] button.
RFQ/PO Form, Tab 5) Primary KPI

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FAQ

QMSCAPA License

What’s the difference between the QMSCAPA License-Free application version vs. the QMSCAPA Multi-User License?

A user license is not required to download the QMSCAPA single-user application, and this version includes all features found in the multi-user version. The single-user version is not a limited-feature demo but a fully functional version. It is referred to as “license-free” because no payment is required for a single user. The key distinction is the limit of one user at a time. 

Key differences between the free and paid versions:

  • Single-user license (free): Allows only one user to operate the application at a time.
  • Multi-user license (paid): Supports two or more concurrent users and requires a purchased license for each user. For larger businesses, ABCI recommends running the application on a Windows Server with Terminal Services or Remote Desktop Connection. 

Learn more about QMSCAPA multi-user licenses

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QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.34.2

Enhancements and Fixes

Human Resources Form

The the image above:

  • The Format Full Name [Button Control] will accurately format a persons full name regardless the presence of a Middle Name.

Linking Employee Record to the QMSCAPA System User Table

In the image above:

  1. Select Tab 7) = …
  2. Unlock Record
  3. Select Type of User as QMSCAPA System User. An Authorized Signer must be a QMSCAPA User.

Link the Unlocked System User Record

*Requires a ‘Supervisor User’ to complete this process.’

In the image below:

  1. Select Tab 6) User Profile +Login.
  2. Click on the [+ Select from User List] control button. You must be a QMSCAPA Supervisor User to execute this process.

In the image below:

  1. Create a New User or
  2. Select and existing User
  3. To confirm the correct User Login click on the [Select highlighted User Login]

In the image below:

  1. Employee Record Name.
  2. The link to Employee Record is now related to the selected User Login.
Categories
ISO 22716

Using QMSCAPA as a Complement to an ISO 22716 Standard for GMP Management Systems

Evaluation of QMSCAPA as a Complement to an ISO 22716 Management System

By Jack T. Bogle (assisted by GROK)

ISO 22716:2007 outlines Good Manufacturing Practices (GMP) specifically for cosmetics manufacturing, emphasizing quality control, documentation, personnel competence, non-conformance handling, internal audits, and traceability to ensure product safety and regulatory compliance.

While ISO 22716 is not a full Quality Management System (QMS) standard like ISO 9001 (on which AS9100 is based), it shares core QMS principles, particularly in documentation, corrective actions, and audits.

QMSCAPA, a Windows-based software designed for ISO 9001:2015-compliant QMS and Corrective and Preventive Actions (CAPA), explicitly supports ISO 22716 alongside standards like AS9100, ISO 13485, and others. Its features can significantly complement an ISO 22716 management system by providing structured, digital tools to automate and streamline GMP processes, reducing manual errors, enhancing traceability, and facilitating FDA alignment (e.g., via 21 CFR Part 11 and 820 compliance for electronic records and quality systems).

Below, we explain how QMSCAPA complements ISO 22716, organized by key ISO 22716 sections. This assessment is based on QMSCAPA’s core modules, which include a QMS dashboard, CAPA tools, documentation controls, audit planning, training management, non-conformance logging, risk assessments, supplier evaluation, and quality metrics calculators. These features, derived from its design for aerospace (AS9100) and general ISO QMS, extend well to cosmetics GMP due to overlapping requirements for risk-based quality management and process control.

1. Documentation and Record-Keeping (ISO 22716 Section 8)

  • Complementarity: ISO 22716 requires comprehensive documentation of processes, deviations, and corrective measures, including SOPs, batch records, and traceability logs. QMSCAPA’s Master Document Index and Revision Journal module provides a centralized repository for creating, versioning, and controlling documents, ensuring easy access and audit trails. This aligns with the software’s multilevel access security and multi-language support, which can handle cosmetics-specific documents like formulation recipes or stability test records.
  • Added Value from AS9100/ISO Features: AS9100’s emphasis on configuration management translates to robust revision control in QMSCAPA, preventing unauthorized changes—a common GMP risk.
  • Benefits: Automates document approval workflows, reducing paper-based errors and supporting electronic signatures for FDA compliance. This could cut documentation time by 30-50% in a cosmetics facility, based on typical QMS software efficiencies.

2. Personnel and Training (ISO 22716 Section 3)

  • Complementarity: The standard mandates training, hygiene protocols, and role definitions to prevent contamination. QMSCAPA’s Employee Training Programs module tracks training schedules, competencies, and effectiveness verification (e.g., quizzes or observations), allowing you to log GMP-specific training like hygiene or equipment handling.
  • Added Value from AS9100/ISO Features: AS9100 requires competency-based training with evidence of effectiveness, which QMSCAPA enforces through records and reports, ensuring personnel are qualified for high-risk cosmetics tasks (e.g., sterile filling).
  • Benefits: Generates training reports for audits, helping maintain compliance during FDA inspections. It also integrates with the QMS dashboard to monitor training completion rates as a KPI, promoting a culture of continuous competence.

3. Non-Conforming Products and CAPA (ISO 22716 Section 12)

  • Complementarity: ISO 22716 requires procedures for identifying, segregating, and correcting non-conforming products (e.g., off-spec batches due to contamination). QMSCAPA’s dedicated Non-Conforming Products module logs issues, while its CAPA tools (Corrective Action Form & Log, Preventive Action Form & Log, and Custom CAPA Form Generator) enable root cause analysis using built-in tools like Fault Tree Analysis and Five Whys—ideal for investigating GMP deviations such as raw material impurities.
  • Added Value from AS9100/ISO Features: AS9100’s risk-based CAPA (aligned with ISO 9001 Clause 10.3) brings structured risk assessments (pre- and post-mitigation) to QMSCAPA, allowing prioritization of cosmetics risks like microbial contamination.
  • Benefits: Automates CAPA workflows with notifications and timelines, ensuring timely resolutions and reducing recurrence rates. The CAPA Report Builder provides graphical charts for trend analysis, supporting proactive GMP improvements.

4. Complaints, Recalls, and Customer Feedback (ISO 22716 Section 13)

  • Complementarity: The standard demands procedures for handling complaints and recalls, including root cause investigations. QMSCAPA’s Customer Complaints and Feedback module logs issues (e.g., adverse skin reactions), links them to CAPA, and integrates with satisfaction surveys to track trends.
  • Added Value from AS9100/ISO Features: Aerospace’s stringent feedback loops (e.g., for safety-critical parts) enhance QMSCAPA’s ability to handle cosmetics-specific recalls, ensuring traceability from complaint to product withdrawal.
  • Benefits: Facilitates FDA-required adverse event reporting by generating compliant reports, while the On-Time Delivery Log & Calculator monitors post-recall distribution impacts, improving customer trust and regulatory readiness.

5. Internal Audits (ISO 22716 Section 14)

  • Complementarity: ISO 22716 requires regular internal audits to verify GMP compliance. QMSCAPA’s Internal Audit Plan and Report module schedules audits across standards (including ISO 22716), generates checklists, and tracks findings with links to CAPA.
  • Added Value from AS9100/ISO Features: AS9100 mandates process audits with objective evidence, which QMSCAPA supports through its multi-standard audit templates, adaptable for cosmetics areas like premises cleanliness or equipment calibration.
  • Benefits: Produces graphical KPI charts (e.g., audit closure rates) for management reviews, streamlining preparation for third-party ISO 22716 certification or FDA inspections. This can reduce audit preparation time significantly.

6. Quality Control and Monitoring (ISO 22716 Sections 10 and 11)

  • Complementarity: For finished products, storage, and distribution, ISO 22716 needs testing records and traceability. QMSCAPA’s Monitoring and Measuring Device Database tracks equipment calibration (e.g., pH meters for cosmetics), while quality metrics calculators (Manufacturing & Production Quality Metrics, Purchasing Quality Metrics) monitor batch yields and supplier performance.
  • Added Value from AS9100/ISO Features: The software’s supplier evaluation module (for outsourced processes) aligns with ISO 22716’s subcontracting requirements (Section 15), using AS9100-style vendor scorecards to assess raw material suppliers.
  • Benefits: The QMS Dashboard provides real-time KPIs like defect rates or stability test compliance, enabling data-driven decisions for cosmetics shelf-life validation and reducing waste in storage/distribution.

7. Risk Management and Supplier Oversight (Cross-Cutting, Aligned with ISO 22716 Sections 7 and 15)

  • Complementarity: While ISO 22716 implies risk controls (e.g., for raw materials), QMSCAPA’s Risk Assessments module explicitly supports identification and mitigation, complementing GMP’s focus on contamination prevention.
  • Added Value from AS9100/ISO Features: AS9100’s operational risk management (Clause 8.1.3) is embedded, making QMSCAPA suitable for cosmetics risks like supply chain disruptions affecting ingredients.
  • Benefits: Outsourced Suppliers and Vendors Evaluation module ensures GMP-compliant vendor audits, with metrics to flag high-risk suppliers—vital for cosmetics traceability.

Overall Benefits of Integration

  • Efficiency and Scalability: QMSCAPA’s multi-user support (via Windows Server with Remote Desktop) and free/demo availability make it cost-effective for small-to-medium cosmetics manufacturers. It centralizes GMP data, potentially reducing compliance costs by 20-40% through automation.
  • Regulatory Alignment: Direct ISO 22716 support, plus FDA 21 CFR compliance, bridges cosmetics GMP with U.S. requirements (e.g., preventing adulteration). For global operations, it aids EU Cosmetics Regulation (EC) No 1223/2009 compliance.
  • Customization for Cosmetics: While AS9100-focused, its modular design allows tailoring (e.g., custom CAPA forms for batch-specific issues), though cosmetics-unique needs like visual inspection logs might require add-ons.
  • Potential Limitations: QMSCAPA may lack built-in cosmetics-specific templates (e.g., for microbial testing protocols), requiring initial configuration. It’s Windows-only, so cloud integration might need third-party tools. For highly regulated pharma-cosmetics, verify full alignment with ISO 22716 via a pilot.

In summary, QMSCAPA strongly complements an ISO 22716 management system by providing a robust, ISO 9001/AS9100-derived platform that automates core GMP elements like CAPA, audits, and documentation. It enhances traceability and risk management, making it an excellent tool for cosmetics manufacturers seeking integrated QMS-GMP solutions. If you provide more details on your QMSCAPA implementation or specific ISO 22716 pain points, I can refine this evaluation further.

Categories
QMSCAPA Update

QMSCAPA 2.33.1

Enhancements and Fixes

Module for Alerts, Incidents, Messages +Non-Conformance Reports (AIMNCR)

  1. Duplicate an AIMNCR record for adding/editing NC Disposition Codes
  2. Expanded the NC Disposition Code from 8 to 16 characters
  3. Lookup Customer Contracts/Orders directly from the AIMNCR form module.

Managing Training Programs, Scheduling and Training Results

The options for recording the validation of training effectiveness were expanded.

Practical Tips for establish validation methods:

  • Define Clear Objectives: Ensure training goals are specific, measurable, achievable, relevant, and time-bound (SMART).
  • Use Mixed Methods: Combine quantitative (e.g., test scores) and qualitative (e.g., demonstrations, interviews) methods for a holistic view.
  • Align with Organizational Goals: Focus on metrics that matter to the organization, like cost savings or customer retention.

Monitoring and Measuring Devices and Equipment

An Asset field [Asset Id] was added to the Monitoring & Measure Devices module.

Categories
Management Review Quality Management Systems

Management Review

Event or a process for continual improvement?

In Quality Management Systems (QMS) like AS9100D and ISO 9001:2015, Management Review is not just an event, but a crucial process for continual improvement. 

Here’s why:

  • Systematic Evaluation: Management Review is a regular, systematic process where top management evaluates the performance of the QMS to ensure its continuing suitability, adequacy, and effectiveness.
  • Performance Monitoring: It allows for monitoring the performance of processes, products, and services, identifying trends, and assessing the achievement of quality objectives.
  • Strategic Alignment: Management Review helps align the QMS with the organization’s strategic direction, ensuring that the QMS contributes to overall business goals.
  • Identification of Improvement Opportunities: The review process provides a platform for identifying areas for improvement, addressing nonconformities, and taking corrective and preventive actions.
  • Resource Management: It helps in assessing resource needs, including personnel, infrastructure, and training, and allocating them effectively to support the QMS.
  • Basis for Decision-Making: Management Review provides critical data and information that enables informed decision-making regarding changes to the QMS, policies, objectives, and resource allocation.
  • Fosters Continual Improvement: By regularly reviewing and acting upon the outputs of the management review, organizations create a culture of continual improvement, leading to enhanced performance and customer satisfaction. 

Key elements of the Management Review process:

  • Planned Intervals: The reviews are conducted at planned intervals, determined by the organization based on its size, complexity, and needs.
  • Required Inputs: Relevant information is gathered and presented as input, including customer feedback, audit results, performance data, status of corrective actions, and changes affecting the QMS.
  • Outputs: The outputs include decisions and actions related to improvement opportunities, changes to the QMS, and resource needs.
  • Documentation: Records of the management review, including minutes, decisions, and actions, are retained to demonstrate evidence of the process. 

In summary, Management Review in AS9100D and ISO 9001:2015 is a vital process that goes beyond a single meeting or event. It is a continuous cycle of evaluation, analysis, and decision-making that drives improvement and ensures the effectiveness of the QMS. 

Categories
QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.32.1

QMSCAPA version 2.32.1 introduces important enhancements, more new reports, and direct print buttons.

Sales Quote and Contract Review

Two new direct print buttons have been added to the Sales Quote and Contract Review module to aid in the contract review requirements published of AS9100D and ISO 9001:2015 Quality Management Standards, which are paraphrased below:

AS9100D & ISO 9001:2015, Clause 8.2.3.1
The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to the customer, to include:

  • a. requirements specified by the customer, including the requirements for delivery and post-delivery activities;
  • b. requirements not stated by the customer, but necessary for the specified or intended use, when known;
  • c. requirements specified by the organization;
  • d. statutory and regulatory requirements applicable to the products and services;
  • e. contract or order requirements differing from those previously expressed.

This review shall be coordinated with applicable functions of the organization.

If upon review the organization determines that some customer requirements cannot be met or can only partially be met, the organization shall negotiate a mutually acceptable requirement with the customer.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

Clause 8.2.3.2 The organization shall retain documented information, as applicable:

  • a. on the results of the review;
  • b. on any new requirements for the products and services.
Quote and Contract Review for AS9100D and ISO 9001:2015
QMSCAPA Contract Review module

In the image above (QMSCAPA Contract Review module:

  • a) Print Log (All);
  • b) Print Log (Sold);
  • c) Print Log (PWO) production work-order;
  • d) Print as Quote/Order with prices or without prices;
  • e) Print as Contract Review;
  • f) Print as PWO.

On-Time Delivery

The On-Time Delivery (OTD) Journal for OTD Per Shipment module was fixed and enhanced when validating “user defined” data labels and data in the form for the OTD Journal.

In AS9100D & ISO 9001:2015, Clause 8.1 Operational Planning and Control (paraphrased):

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by:

  • determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery of products and services;
QMSCAPA module for monitoring On-Time Delivery (OTD)

Guidance for USING QMSCAPA Reports Used in the Management Review Process

ABCI Consultants has updated its guidance for establishing and maintaining Management Review as a process by using QMSCAPA to document the Management Review inputs, which includes a plan for how the review shall be carried out taking into consideration:

  • a. the status of actions from previous management reviews;
  • b. changes in external and internal issues that are relevant to the quality management system;
  • c. information on the performance and effectiveness of the quality management system, including
  • trends in:
    • 1) customer satisfaction and feedback from relevant interested parties;
    • 2) the extent to which quality objectives have been met;
    • 3) process performance and conformity of products and services;
    • 4) nonconformities and corrective actions;
    • 5) monitoring and measurement results;
    • 6) audit results;
    • 7) the performance of external providers;
    • 8) on-time delivery performance (AS9100D)
  • d. the adequacy of resources;
  • e. the effectiveness of actions taken to address risks and opportunities (see 6.1);
  • f. opportunities for improvement.
Guidance for USING QMSCAPA Reports Used in the Management Review Process
Download PDF

Download Guidance for USING QMSCAPA Reports Used in the Management Review Process

This ABCI guidance document refers to the following AS9100D & ISO 9001:2015 Quality Management Systems —
Requirements, beginning with Clause 9 Performance evaluation, 9.3 Management Review.

Categories
QMSCAPA Update

QMSCAPA 2.31.14

QMSCAPA version 2.31.1 introduces important enhancements, new reports, and direct print buttons.

Additional Reports with Direct Print Buttons

Advanced CAPA Search & Report

QMSCAPA offers an advanced, user-friendly feature for searching corrective action and preventive action records. Here a six tips to get started:

  1. Start by navigating to the menu Browse Logs > Advanced CAPA Search.

2. Select the [Search] button option.

3. Enter text to search for any field of the CAPA log table.

4. Click the [Finish] button to complete the search.

5. Click on the [CAPA Tagged] print button.

6. Select an Order the the report data.

Human Resource by Department

  • Added to the Human Resource table a new direct print button and report showing the resources of a selected single Department Name.

Monitoring and Measurement Device Table

  • Added to the Monitoring and Measurement Device table a new direct print button and report showing the resources of a selected or single Location Name.
Display Screen Text Editor

Enhancements to the Display Screen Text Editor

The QMSCAPA Display Screen Text Edit (DSTE) allows an Administrator User (AU) to modify the text within the QMSCAPA program at runtime. This includes all visible text such as buttons, menu options, prompts, and window captions. The text can be altered or translated from English to any other language that uses the Latin alphabet.

This feature enables the AU to create multi-language versions of the QMSCAPA application, where users can translate the text as needed.

It also allows users to adjust terminology within the program, even if they are using the same language. This helps to make the program more familiar and user-friendly. For example, in some countries, the term “ZIP Code” is used, while in others, it is referred to as “Postal Code.” Even specific words like “color” and “colour” can have different spellings in different countries.

The DSTE allows these terms to be customized to best suit the user’s preferences.

The QMSCAPA database with the Display Screen Text is only included with the QMSCAPA ‘license-free demo.’ This demo version is used for initial installation on a stand-alone Windows computer or a multiple-user Windows OS server.

Any QMSCAPA ‘official update installers’ will not include the Display Screen Text database. QMSCAPA is shipped with a default database. Rest assured, any translations or text changes made by the AU will not be overwritten by subsequent software updates.

Passive Software Record Locks

Active Lock the Open Record

We continue to on work on improving the passive software record lock (PSRL). Typically PSRL refers to a security mechanism that automatically restricts access to certain software features or data without requiring active user intervention. This can be used to prevent unauthorized access or to ensure that only authorized users can perform specific actions within the software.

Also, we have added [Active Lock button] to many of the record editor windows. This gives users more control over when to lock records actively, complementing the passive security measures already in place.

Categories
QMSCAPA User Tips

Approving & Verifying Documented Information

This QMSCAPA User Tip applies to the Document Control Module, and focuses on an alternate method of approving and verifying documents without using the QMSCAPA document change log and electronic approval journal.

  • Open a document control record form the Document Control Index or the Document Tree.
  • Go to Tab 2) Version Approval and History
    • #1) If any Required Approvals are checked, then uncheck these Required Approvals.
    • #2) Enter #1 into the [Verified] field.
    • #3) Check [Approval Verified] field.
    • #4) QMSCAPA will automatically place “Today’s Date” into the [Date Approved] field. Therefore, you may need to enter an appropriate [Date Approved]. Typically, the “Date Approved” should be prior to or equal to the [Effective Date] field.
    • #5) Go back to Tab 1) Document Description.
  • Return to Tab 1) Document Description
    • Check the [Use Alphanumeric] checkbox,
    • Verify the [Version Number] field version number matches the File-Naming-Convention (FNC) or by opening the document if the FNC does include the document version and effective date.
    • Verify the [Effective Date] field matches the effective date of the document attached and described in the Document Control Record.
    • Verify the contents in the [Document Status] field. If the document is approved and verified then select the appropriate Status. Example best practice, Approved, Uncontrolled when printed.
    • Select or enter the “Approved by Title” in the [Approved by Title] field.
  • Recommendation: Add a document description or purpose to the [Document Description/Purpose] field.
Categories
QMSCAPA Update

A comparison between Windows Remote Desktop Services (RDS) and TSPLUS®:

Windows Remote Desktop Services (RDS)

Platform: Primarily Windows-based, with support for Mac and Linux via third-party solutions.

Deployment: On-premises or cloud-based via Azure.

Security: Advanced security features including SSL encryption, Network Level Authentication (NLA), and continuous access evaluation policies.

Performance: Optimized for hosting applications and desktops with RD Session Host Configuration.

Management: Integrated with Active Directory for user and group management, and enhanced RD Licensing Management.

Pricing: Typically part of a Windows Server license, with additional CALs required.

TSPLUS®

Platform: Supports Windows 10, 11, Windows Server, Mac, Linux, SaaS, and Web-based solutions.

Deployment: On-premises or cloud-based, with a focus on ease of deployment.

Security: Offers SSL encryption and smart card authentication for secure remote access.

Performance: Known for its ease of use and quick setup, making it suitable for small to medium-sized businesses.

Management: Provides centralized management for remote access, application delivery, and remote printing.

Key Differences

Platform Support: TSPLUS offers broader platform support compared to RDS.

Deployment Flexibility: TSPLUS is often praised for its ease of deployment and setup.

Security Features: Both offer robust security features, but RDS has more advanced options integrated with Windows Server.

Management Tools: RDS is deeply integrated with Windows Server management tools, while TSPLUS offers a more streamlined approach.

Ultimately, the choice between RDS and TSPLUS depends on your specific needs, such as platform requirements, deployment preferences, and budget.