Category: QMSCAPA Update

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Document Control QMSCAPA User Tips Quality Management Systems

QMSCAPA Document Control

Document control is critical in ISO 9001:2015/2026 and other Quality Management Systems because it is the mechanism that keeps your QMS accurate, consistent, auditable, and protected from the single biggest source of nonconformances: people using outdated or uncontrolled documents.

Document control ensures that only the correct, approved, current version of every quality‑related document or record is available and used. Without it, processes drift, errors multiply, and audits fail.

Why Document Control Is Important in Quality Management Systems like ISO 9001:2015/2026

  1. It prevents the #1 global audit failure. Audit bodies consistently report that document control failures are the most common nonconformance worldwide — especially outdated work instructions, missing approvals, or uncontrolled revisions. If an operator uses Rev C while the master list shows Rev E, that is an automatic major nonconformance.
  2. It ensures compliance with Clause 7.5 (Documented Information). ISO 9001:2015 requires organizations to create, update, and control documented information so it is:
    • Approved before use
    • Identified (title, date, author, revision)
    • Version‑controlled
    • Available where work is performed
    • Protected from unauthorized changes
    • Retained or disposed properly
    • This applies to all formats — paper, digital, cloud, photos, forms, templates, supplier specs, etc.
  3. It keeps processes consistent and repeatable. Documents like SOPs, work instructions, and process maps define how work must be done. If different teams use different versions, you lose process consistency — which breaks the core ISO principle of “say what you do, do what you say.”
  4. It protects the integrity of records. Records (audit logs, inspection results, training records) are evidence that work was performed. Without proper control, you cannot prove compliance. They must be:
    • Retained
    • Protected
    • Retrievable
    • Tamper‑proof
  5. It ensures employees always use the correct instructions
  6. Clause 7.5.3 requires documented information to be available at the point of use. If operators cannot easily access the correct version, they will improvise — leading to quality escapes, rework, and customer complaints.
  7. It prevents uncontrolled changes. Unapproved edits, outdated templates, or “tribal knowledge” workarounds create risk. Document control enforces:
    • Formal review
    • Approval workflows
    • Change history
    • Controlled distribution
  8. It enables effective training and competency. Training materials, job instructions, and competency records must be controlled so employees are trained on current processes — not outdated ones.
  9. It reduces risk and improves operational reliability. A strong document control system reduces:
    • Production errors
    • Scrap and rework
    • Safety incidents
    • Customer returns
    • Audit findings
  10. It is the backbone of a digital, scalable QMS. Digital document control eliminates 90% of common audit failures compared to paper systems. It also supports automation, workflows, and real‑time access.
    • Document control is not administrative overhead — it is the infrastructure that keeps your QMS functioning.
    • It ensures accuracy, consistency, compliance, and audit readiness across every process.

QMSCAPA Document Control Index and Version Control Journal

The Document Control Index (DCI) in QMSCAPA is the software’s central hub for managing all controlled documents in an ISO‑compliant quality management system. It acts as the master document index, the revision history log, and the approval journal all in one place. Everything in QMSCAPA related to document governance flows through this module.

Core Purpose of the QMSCAPA DCI

The DCI is a centralized database that records every controlled document along with its metadata, revision history, approval status, and storage location. It ensures traceability, version control, and compliance with ISO 9001, AS9100, IA9100:2026, ISO 13485, and other standards.

What the Document Control Index Tracks

These fields below allow auditors and users to instantly verify the current revision, approval status, and history of any controlled document.

  1. Alpha & numeric version codes
  2. Approval journal (who approved, when, and by what method)
  3. Date created / revised / approved / effective / last saved
  4. Document path and file name (local or URL hyperlink)
  5. Document identification (SysDocId + user-defined Doc ID)
  6. Document type and title
  7. Revision history journal

How the Interface Works

The DCI screen is divided into functional sections:

  1. Browse Table Sortable by:
    • Document ID
    • Document Title
    • File Path
    • Department
    • Status
    • System Document ID
    • Document Type This gives quick navigation across large document sets.
  2. Add / Edit / Delete Controls
    • Used to maintain the document index.
  3. Active Document Record
    • Selecting a row shows the linked file path/URL for the current revision.
  4. Revision History Journal
    • Displays all version changes for the selected document.
  5. Approval Journal
    • Shows all approvals, including e‑signatures and verification steps.
  6. Document Control Reports
    • Includes:
    • Documents requiring approval
    • Document change notices
    • Master Document Index
    • Documents approved

Tabs Inside the Document Control Index Form

The DCI form itself has four functional tabs:

  1. Tab 1 — Document Description
    • Contains SysDocId, user Doc ID, revision dates, approval dates, effective date, title, file path, and approval requirements.
  2. Tab 2 — Version Approval & History
    • Shows the full approval log, e‑signatures, and version history.
  3. Tab 3 — Document Text Editor
    • Provides access to QMSCAPA’s built‑in document generator and editor.
  4. Tab 4 — Options
    • Additional document control settings, including approval verification logic.

Approval Workflow Features

  1. QMSCAPA’s DCI includes structured approval logic:
    • Required approvers are defined by job title.
  2. The system tracks:
    • Number of approvals required
    • Number completed
    • Number verified
  3. When all conditions are met, the Date Approved is automatically set. This ensures compliance with ISO and FDA 21 CFR 11 requirements for controlled documents.

Role in the Overall QMSCAPA System

The DCI is part of QMSCAPA’s broader quality management suite, which includes CAPA logs, internal audits, training records, supplier evaluations, and more.

Categories
QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.37.2

How QMSCAPA is Helping Small to Large Businesses Improve their Quality Management System

  1. Checklist Generator for Evaluating Business Opportunities and Process.
  2. Module for managing Corrective and Preventive Actions.
  3. Module for managing Customer Complaints and other feedback.
  4. Module for Evaluating Customer Satisfaction.
  5. Monitoring & Measuring KPI for Contract Review and Sales Processes.
  6. Monitoring & Measuring KPI for Purchasing Processes, including on-time delivery by suppliers.
  7. Monitoring & Measuring KPI for on-time delivery to customers.
  8. Module for managing Purchasing Processes.
  9. Quality Performance Dashboard for report KPI results and Continual Improvement.
  10. Module for managing Risk Assessments with Interested Parties
  11. Module for managing Sales Quotes, Contract Review and Production Work Orders.
  12. Module for managing and evaluating Supplier Performance, including Quality Surveys with Suppliers.

Recording Supplier On-time Delivery in the Purchasing Quality Module

In Quality Management Systems, such as AS9100 and ISO 9001, the Monitoring, Measurement, Analysis, and Evaluation of Suppliers become even more powerful when applied specifically to Purchasing and Supply Chain Management, because suppliers are often the largest source of variation, risk, and customer dissatisfaction in both AS9100 and ISO 9001. Applying the discipline of Monitoring, Measurement, Analysis, Evaluation, and Customer Satisfaction to the supply chain turns purchasing from a transactional function into a strategic quality control mechanism.

To comply with AS9100 and ISO9001—and to operate a mature Quality Management Systems—organizations must establish Key Performance Indicators (KPIs) that quantify performance and variation.

Statistical Process Control (SPC) is one of the most powerful tools for this.

How KPIs and SPC strengthen the QMS:

  • Make variation visible. Concise SPC reports and charts show whether a process is stable, trending, or out of control—something raw data cannot reveal.
  • Identify root causes faster. When a KPI shows a spike or drift, SPC helps pinpoint whether the cause is common‑cause variation (systemic) or special‑cause (specific event).
  • Support predictive quality. Standard deviations, control limits, and capability indices (Cp, Cpk) show whether a process can meet requirements consistently.
  • Provide early warning signals. Management can intervene before defects reach the customer.
  • Enable fact‑based Management Review. Leadership sees not just results, but process capability, risks, and opportunities for improvement.

Why standard deviation matters

Standard deviation quantifies how much variation exists in a process. When used in SPC:

  • It defines control limits “plus or minus three sigma(±3σ), which determine whether a process is stable.
  • It reveals whether a process is capable of meeting tolerance.
  • It helps management distinguish between noise and meaningful signals.
  • Without standard deviation and SPC, KPIs become lagging indicators—useful only after problems occur.
Purchasing Quality Measurements
  • In procurement and supply chain management, on-time delivery (OTD) from critical suppliers is a standard KPI that is closely monitored to ensure supply chain reliability.
  • Tracking on-time delivery (OTD) performance for critical suppliers serves as a vital KPI in supplier management.
Purchasing Quality Metrics module for recording Purchasing KPIs
  • The button [OTD (All)] – Reports all Supplier On-time Delivery performance based upon a date range.
  • The button [OTD (1)] – Reports the highlighted Suppler OTD performance by date range.

Customer Sales Contract Review Processes

Customer Communication (AS9100D 8.2.1 / ISO 9001 8.2.1)

Practical methods

  • Formal quoting process with controlled templates.
  • Documented communication matrix defining who may speak to customers about what topics.
  • Engineering change request (ECR/ECO) workflow for customer‑initiated changes.
  • Customer complaint log integrated with corrective action processes.
  • Project progress and production meetings for complex or high‑risk orders.

Required records which may be generated and/or maintained with QMSCAPA

  • Quote records and revisions.
  • Contract review, approvals required and dates
  • Production Meeting minutes or kickoff notes.
  • Complaint records and corrective actions.
  • Engineering change documentation.
  • Customer change order documentation

Determining Requirements for Products and Services (AS9100D 8.2.2 / ISO 9001 8.2.2)

What organizations must achieve

  • Identify explicit, implicit, and regulatory requirements.
  • Ensure requirements are complete, unambiguous, and feasible before acceptance.

Practical methods

  • Technical data package (TDP) review including drawings, specifications, models, and standards.
  • Regulatory applicability review (e.g., ITAR, DFARS, RoHS, REACH, special processes).
  • Risk assessment for unusual materials, tolerances, or delivery expectations.
  • Supplier capability review if outsourced processes are involved.

Required records which may be generated and/or maintained with QMSCAPA

  • TDP review forms.
  • Risk assessments (FMEA, risk log, or AS9100D‑aligned risk matrix).
  • Supplier capability or special process approvals.
  • Regulatory compliance confirmations

Review of Requirements for Products and Services (AS9100D 8.2.3 / ISO 9001 8.2.3)

What organizations must achieve

  • Ensure all functions (sales, engineering, quality, production, supply chain) agree the requirements can be met.
  • Identify gaps, conflicts, or risks before acceptance

Practical methods

  • Cross‑functional review meetings for complex orders.
  • Feasibility analysis for tolerances, materials, lead times, and capacity.
  • Configuration review to ensure correct drawing revisions and specifications.
  • ERP‑driven review gates that prevent job release until review is complete.

Required records which may be generated and/or maintained with QMSCAPA

  • Signed contract review forms or electronic approvals.
  • Feasibility assessments.
  • Revision verification records.
  • Capacity or scheduling confirmations.
  • Notes from cross‑functional review meetings.

Coordinating the Review with Applicable Functions

What organizations must achieve

  • Prevent “sales‑only” commitments that production or quality cannot meet.

Practical methods

  • Electronic workflow requiring approvals from engineering, quality, and operations.
  • Gate reviews (e.g., Gate 1: Sales; Gate 2: Engineering; Gate 3: Quality).
  • Integrated ERP/PLM systems (QMSCAPA software) that enforce multi‑department review.

Required records

  • RACI matrix or responsibility assignment documentation.
  • Workflow approval logs.
  • Gate review checklists.
  • Evidence of cross‑functional communication (meeting notes, emails, ERP logs).

When Requirements Cannot Be Met (AS9100D 8.2.3.1 / ISO 9001 8.2.3.1)

What organizations must achieve

  • Identify any requirement that is unclear, unrealistic, or impossible to meet.
  • Negotiate a mutually acceptable alternative before accepting the order.
  • Prevent unapproved deviations or assumptions.

Practical methods

  • Technical clarification forms documenting questions and customer responses.
  • Revised quote or contract amendment reflecting the negotiated change.
  • Risk‑based decision making to determine whether to accept modified requirements.
  • Customer approval of exceptions (email, signed form, or portal confirmation)

Required records which may be generated and/or maintained with QMSCAPA

  • Revised quotes, purchase orders, or contracts.
  • Clarification logs.
  • Updated TDP or controlled documents.
  • Risk assessments supporting the decision.
Categories
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

Categories
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
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
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
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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.

Categories
QMSCAPA User Tips

Statistical Process Control (SPC)

Statistical Process Control (SPC) is a method used in QMSCAPA software, among other Quality Management Systems, to monitor and control a process through statistical analysis. Here are some basic SPC tools and techniques found in QMSCAPA:

  1. Control Charts: These charts help monitor process performance over time and identify variations. They distinguish between common cause variation (inherent to the process) and special cause variation (due to external factors).
  2. Pareto Charts: These charts identify and prioritize the most significant factors in a process, helping to focus improvement efforts on the most impactful areas.
  3. Histograms: These are bar charts that show the distribution of data, helping to understand the variation within a process.
  4. Scatter Diagrams: These diagrams show the relationship between two variables, helping to identify correlations and potential causes of variation.
  5. Cause-and-Effect Diagrams (Fault-Tree Diagrams): These diagrams help identify potential causes of a problem, organizing them into categories for easier analysis.
  6. Check List/Sheets: These are simple forms used to collect and analyze data, often used for tracking defects or occurrences.

By using these tools, organizations can detect issues early, improve process stability, and enhance overall quality.