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Achieve Compliance Across Industries with BizPortals QMS for Enhanced Quality Management

BizPortals QMS, a SharePoint-based quality management system, empowers users to configure their solutions according to the industry-specific regulatory requirements. From offering robust document control to conducting comprehensive audits, it offers dedicated features and tools to seamlessly adhere to compliances. Furthermore, organizations can customize an entirely new module, create new form templates, add or modify workflows, create document repositories, and more to meet compliance requirements.
Here are some industry-specific compliances that can be referred to while creating a robust quality management strategy:

ISO 9001

ISO 9001 is an internationally recognized standard that outlines the requirements for a Quality management system. ISO 9001 is applicable to any organization irrespective of size, type, or industry. The primary aim of ISO 9001 is to help organizations meet customer requirements, improve operational processes, enhance customer satisfaction, and drive continuous improvement.

1. Document control

ISO 9001 mandates effective document control and suggests clear guidelines for managing and handling documented information to ensure proper versioning, formatting, and approvals. This improves the overall accessibility, security, and integrity of the information.

2. Audit trails

ISO 9001 provides for internal audits and traceability that includes recording and managing evidence of compliance, corrective actions, and findings. However, having features like tracking changes, audit logs, and a dedicated audit management module to manage audit schedules can be helpful.

3. Workflows

ISO 9001 requires organizations to clearly define and manage workflows for specific processes that impact the quality of the products and services. Automating tasks such as document routing, approvals, reminders, and notifications and efficiently assigning and tracking tasks can help streamline the operational workflow and planning.

4. Centralized repository

Clause 7.5.3 of ISO 9001 requires that the documented information must be stored and readily accessible by authorized individuals. Document libraries offered by SharePoint-based solutions act as centralized repositories to create, store, and manage documents. Also, features like metadata integration, search filters, and co-authoring help users quickly search, identify, trace, and retrieve information in a few easy steps.

5. Customizable solutions

ISO 9001 encourages organizations to tailor their processes to meet quality objectives and business needs. BizPortals QMS allows users to create custom modules, workflows, forms, lists, libraries, and dashboards to easily meet their industry-specific requirements.

FDA 21 CFR Part 11

FDA’s 21 CFR Part 11 mandates the use of electronic records and electronic signatures in order to ensure the authenticity, integrity, and reliability of the information associated with the quality operations. However, the below given points can help organizations align their processes with the FDA 21 CFR Part 11 requirements.

1. Electronic records

It requires organizations to ensure that electronic records are accurate, reliable, readable, and accessible throughout their retention period. A SharePoint-based QMS, offers centralized repositories to store the electronic records, ensure easy access and traceability, and enable document versioning, and metadata integration for easy access to accurate and updated information.

2. Audit trails

FDA 21 CFR Part 11 makes it necessary for organizations to maintain computer-generated audit trails to track the creation, modification, and deletion of documentation or electronic records. While BizPortals QMS offers built-in audit logs capturing every action of the users, it allows permission-based access to ensure the records are accessible to authorized personnel only.

3. Electronic signatures

Compliance requires a unique and verified electronic signature for individuals along with their printed name, date, and time of signing to ensure authenticity. SharePoint-based QMS can easily integrate with third-party DocuSign, Adobe Sign, and FDA-compliant electronic tools for secure and effective signature approvals.

4. Access controls

A QMS must limit access to authorized and verify user identity before granting access to electronic records and signatures. However, leveraging a secure authentication mechanism through Azure Active Directory, assigning user roles and permissions for specific records, and assigning granular permissions to restrict actions can be helpful.

5. Backup and recovery

FDA 21 CFR Part 11 requires adequate protection and retention policies for electronic records to ensure that they are accessible and readable for their legally required retention period. SharePoint-based QMS can be configured for retention policies, data backups, and disaster recovery, ensuring the integrity of electronic records over their retention period.

EU GMP Annex 11

Primarily implemented in pharmaceutical, biotechnology, and life sciences industries, EU GMP Annex 11 outlines the requirements for computerized systems. It emphasizes validation, data integrity, audit trails, and electronic records to ensure compliance with the European Union pharmaceutical standards. Here are the key requirements of EU GMP Annex 11 and how organizations can configure their SharePoint-based QMS to adhere to these requirements.

1. Validation 

Requirements : The system needs to be validated to ensure it meets regulatory requirements.

SharePoint-based QMS: It allows users to create detailed validation documentations such as tests plans, execution results, and continuous monitoring plans to ensure your quality management ecosystem is functioning as it should.

Data Integrity

Requirements : Accurate and complete data protected from unauthorized changes.

SharePoint-based QMS: While users can enable role-based permissions to restrict unauthorized alteration of critical information, it also allows them to access previous versions of the documents that can be restored in case of errors.

Audit Trails

Requirements : Every change to data must be logged, and records must be auditable, ensuring traceability.

SharePoint-based QMS: With built-in audit logs that track key activities like document creation, modification, and deletions, the user can create a detailed audit trail for improved compliance and transparency.

Electronic Records and Electronic Signature

Requirements : Electronic records must be managed securely and in a controlled manner, and the quality system must support electronic signatures.

SharePoint-based QMS: With robust document management and control features like document library, metadata tagging, controlled document access, and electronic signatures, organizations can configure a solution that is aligned with regulatory standards.

21 CFR Part 211

21 CFR Part 211, as issued by the U.S. Food and Drug Administration, covers essential regulations regarding Current Good Manufacturing Practices (cGMPs) for pharmaceutical products. It establishes standards to ensure product quality, process control, documentation, and accountability and helps organizations ensure the quality, purity, and identity of drug products.

Regulatory Requirement How a SharePoint-Based QMS Aligns
Document Control
  • Centralized storage for GMP-critical documents.
  • Version control ensures accuracy and traceability.
  • Approval workflows and role-based access for controlled management.
Audit Trails
  • Tracks who accessed, edited, or approved documents.
  • Built-in logging with tamper-proof records.
  • Integrations for enhanced reporting.
Validation
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation ensures system reliability for GMP compliance.
  • Covers IQ, OQ, PQ processes and testing for Part 11 compliance.
Access Control
  • Role-based permissions restrict unauthorized access.
  • MFA and Active Directory integration enhance security.
  • Tracks user actions for accountability.
Change Control
  • Tracks configuration and system updates.
  • Workflows ensure changes are reviewed and approved.
  • Maintains detailed change logs.
Electronic Signatures (21 CFR Part 11)
  • Integrates with DocuSign or Adobe Sign for compliant e-signatures.
  • Ensures signatures are linked to users, timestamped, and tamper-proof.
Training and Qualification
  • Tracks employee training records and certifications.
  • Sends automated reminders for renewals.
  • Centralized storage for training materials ensures access to current SOPs.
Backup and Recovery
  • Automated backups and disaster recovery with Microsoft’s cloud infrastructure.
  • Versioning allows quick recovery of documents.
Record Retention Policies
  • Configurable retention policies enforce compliance.
  • Archived records remain accessible and readable.

HACCP Compliance

HACCP (Hazard Analysis and Critical Control Points) is a well-structured, systematic regulation to ensure that the food is safe for consumption and is free from contamination at every stage of production, processing, and distribution. It becomes mandatory for organizations involved in food manufacturing, beverage production, food services, pharmaceuticals, and more. HACCP identifies, evaluates, and prevents potential biological, chemical, and physical hazards from happening in the food production processes.

HACCP Requirement How SharePoint-Based QMS Helps
Document Control
  • Centralized document libraries store HACCP plans, hazard analyses, and monitoring procedures securely.
  • Version control ensures only the latest approved documents are used and tracks changes for audits.
Audit Trails
  • Built-in audit logs track actions like document creation, modification, and deletion.
  • Provides a complete history of changes to support regulatory inspections and audits.
Workflows and Automation
  • Automates routine HACCP processes like CCP monitoring schedules and corrective action escalations.
  • Sends notifications to responsible personnel for deviations or upcoming tasks.
Training and Employee Records
  • Manages training records to ensure employees are certified in HACCP principles.
  • Sends automated reminders for retraining or certifications when due.
Data and Record Management
  • Facilitates real-time data recording and retrieval for CCP monitoring and validation logs.
Corrective and Preventive Actions (CAPA)
  • Logs and tracks deviations from CCP limits, ensuring corrective actions are documented and followed up.
  • Monitors the status of CAPAs to ensure timely resolution.
Compliance Monitoring and Reporting
  • Real-time dashboards monitor HACCP compliance status and performance metrics.
  • Generates detailed reports for internal audits, regulatory inspections, and management reviews.

SQF Food Safety

Safe Quality Food (SQF) compliance, aligned with the Global Food Safety Initiative (GFSI), is a globally recognized food safety and quality certification program that is outlined to ensure that all food producers, manufacturers, and suppliers maintain strict food safety and quality standards throughout the distribution and supply chain.

SQF Requirement How SharePoint-Based QMS Helps
Document Control
  • Centralized document management with version control, permission-based access, and automated workflows to ensure accuracy.
Audit Trails
  • Tracks document activities (creation, modification, approval) with built-in audit logging for traceability and compliance.
Training Management
  • Stores training materials, tracks completion, and automates reminders for re-certifications to ensure employee compliance.
Risk Management
  • Automates risk assessments, assigns corrective actions, and monitors progress using workflows, custom lists, and dashboards.
Supplier Management
  • Maintains supplier records, certifications, and audit results in a centralized database with automated reminders for updates.
Food Safety Plan and HACCP
  • Stores HACCP plans, tracks critical control points, and provides easy access to documentation during audits or inspections.
Incident Management
  • Logs, tracks, and resolves food safety incidents using issue tracking features, real-time monitoring, and reporting tools.
Continuous Improvement
  • Tracks performance metrics, analyzes trends, and supports collaboration on initiatives to drive ongoing food safety improvement.

GMP Guidelines

Good Manufacturing Practices (GMP), primarily regulated by the U.S. FDA, European Medicines Agency (EMA), and World Health Organization, are a set of regulatory guidelines that ensure that products are produced according to quality standards. They cover industries like foods and beverages, pharmaceuticals, cosmetics, medical devices, and biotechnology and focus on minimizing risks that cannot be eliminated through final product testing.

However, proper configuration, validation, and user training coupled with features like document management and workflow automation and robust collaboration tools offered by SharePoint-based QMS help organizations align their quality management processes with the GMP Guidelines.

ISO 13485:2016

ISO 13485:2016, specifically mandated for the medical device industry, is an internationally recognized standard for quality management systems that ensure the safety and effectiveness of medical devices. ISO 13485:2016 is based on the ISO 9001 principles but adds more stringent requirements like risk management, device traceability, and more to meet the specific requirements of the medical device industry.

Features like document control, process automation, traceability, and audit management industries can align their quality management processes with their requirements. However, proper implementation, validation, customization, and adequate training are necessary to tap the potential of a SharePoint environment fully.

ISO 13485:2016 Requirement How SharePoint-Based QMS Helps
Document and Record Control
  • Centralized storage, version control, metadata tagging, and access restrictions.
Risk Management
  • Tracks risks using customizable workflows and maintains risk logs with assigned actions.
Change Control
  • Automated workflows for notifying stakeholders, managing approvals, and ensuring traceability.
Training Management
  • Tracks training records, sends reminders, and stores proof of staff competence.
Design and Development Control
  • Collaborative environments for design documents with full traceability throughout the lifecycle.
Supplier Management
  • Maintains supplier databases, performance evaluations, and approval workflows.
Audit Trails and Traceability
  • Tracks actions (creation, modification, deletion) with built-in audit logging.
CAPA Management
  • Automates CAPA workflows for identifying, assigning, and resolving non-conformities.
Monitoring and Reporting
  • Integrates with Power BI to provide dashboards and quality reports for real-time monitoring.
Electronic Signatures
  • Integrates with DocuSign or Adobe Sign to ensure compliant and secure approvals.

ISO 31000

ISO 31000 is an international standard for risk management. While ISO 31000 is not legally binding, implementing it can help organizations integrate risk management practices into their quality processes. Furthermore, ISO 31000 empowers organizations to identify potential risks and effectively manage them, enhancing decision-making, resilience, and governance.

Industries where ISO 31000 is used are: 

  • Finance and Insurance
  • Healthcare
  • Energies and Utilities
  • Government and Public Sector
  • Construction and Engineering
  • Information Technolgy
ISO 31000 Requirement How SharePoint-Based QMS Helps
Centralized Risk Documentation
  • Centralized repositories with metadata tagging to store and access risk-related documents.
Risk Assessment Workflow
  • Customizable workflows to automate risk assessment processes.
Audit Trail for Risk Management Activities
  • Version control and audit logging features to track all changes to risk documentation, decisions, and workflows.
Collaboration and Communication
  • Alerts and notifications, team sites, and discussion forums to facilitate seamless communication.
Dashboard and Reporting
  • Intuitive dashboards and reports to monitor risks, trends, and impact of current risks.
Incident Management Integration
  • Dedicated incident management module to log, track, and resolve quality incidents.
Access Controls
  • Role-based permissions, multi-level access control, and more to maintain confidentiality and integrity of sensitive information.

IATF 16949

IATF 16949 is a globally recognized standard for quality management systems in the automotive industry. While it is based on ISO 9001, it includes additional requirements to ensure consistent quality of automotive parts, components, and systems throughout the supply chain. With robust features and dedicated modules to manage documents, audit, CAPA, supplier, training, and more, a SharePoint-based QMS can be configured to meet IATF 16949’s requirements.

IATF 16949 Requirement How SharePoint-Based QMS Helps
Document Control and Management
  • Centralized document libraries with version control, metadata integration, filters, multi-level access permissions.
Audit Management
  • Dedicated module to manage audit schedules, store audit checklists, track findings.
Corrective and Preventive Actions (CAPA)
  • Integrated CAPA module to plan, implement, and track corrective actions with cross-module integration feature.
Training and Competence Records
  • Dedicated training management with centralized database of training records, sessions, resources, and employee qualifications.
Supplier Management
  • Separate module to maintain supplier database and related documents, track supplier performance, and manage supplier audits.
Performance Monitoring and Metrics
  • Real-time dashboards to collect, visualize, and analyze quality data for enhanced decision-making and continuous improvement.
Change Control
  • Enables change request workflows to track, assess, approve, and document changes.
Data Integrity and Traceability
  • Role-based permissions, multi-factor authentication, and detailed audit log to ensure traceability.

ISO 50001

ISO 50001 is an international standard that helps organizations use energy more efficiently, reduce energy costs, and minimize greenhouse gas emissions. However, the key objectives include establishing an energy policy aligned with the organization’s operational needs, setting target-based energy objectives, and monitoring energy performance.

While ISO 50001 is not universally mandatory, it is often required in industries including food and beverages, construction, retail, manufacturing, oil and gas, power generation, mining, and chemical industries. However, with robust features offered by SharePoint, organizations can easily configure their QMS to fulfill the ISO 50001 compliance.

ISO 50001 Requirements How SharePoint-Based QMS Helps
Energy Policy Documentation
  • Centralized repositories to store and manage policies, procedures, and documents.
Energy Data and Monitoring
  • Interactive dashboards to monitor key performance indicators and ensure progress.
Audit and Compliance Management
  • Dedicated audit management module with automated workflows to manage audit schedules, findings, and corrective actions.
Employee Training and Awareness
  • Integrated training management module to manage, control, and track training resources, records, employee learning status.
Non-Conformities and Corrective Actions
  • Seamless tracking and management of non-conformities and corrective actions for easy and faster resolution.
Document Control
  • Robust document control features like metadata tagging, version control, permission management, and more for secure and efficient document management.

HIPAA

Health Insurance Portability and Accountability Act (HIPAA) is a regulatory requirement to safeguard protected health information, improve efficiency, empower patients to access their health data, and more. HIPAA compliance becomes mandatory for organizations involved in the healthcare sector including hospitals, health insurance providers, and associated third-party vendors or service providers. Organizations can leverage a SharePoint-based QMS to adhere to HIPAA compliance.

HIPAA Compliance Requirements How SharePoint-Based QMS Helps
Secure Access Controls
  • Role-based permissions, multi-factor authentication, and granular permission settings to restrict access to sensitive documents, folders, and libraries.
Audit Trails and Monitoring
  • Complete audit logging to track user activity and monitor access, changes, and usage of protected health information.
Data Encryption
  • SharePoint Online, a part of Microsoft 365, complies with stringent data security standards to align with HIPAA requirements.
Data Backup and Recovery
  • It offers a cloud-based platform to provide backups, ensuring business continuity in case of system failures and data loss.
Records Management and Retention
  • Document management capabilities allow users to define retention policies and metadata tagging for easy classification and retrieval of health records, improving traceability and compliance.
Training and Policies
  • Dedicated module with automated workflows to store and manage training resources, materials, and employee training programs.

GLP Good Laboratory Practices

Good Laboratory Practices (GLP) are a set of principles and guidelines to ensure the quality of non-clinical laboratory studies. GLP does not provide the scientific validity of the test methods; instead, it ensures that the non-laboratory practices were conducted in a controlled, documented, and compliant manner. Following GLP compliance is essential in organizations involved in pharmaceuticals, biotechnology, chemicals, cosmetics, food and beverages, agrochemicals, medical devices, and more.

GLP compliance requires clear, proper documentation of SOPs, data integrity, equipment calibration and maintenance, training, document control, quality assurance, and audit trails. By properly configuring a SharePoint-based QMS users can adhere to GLP compliance.

GLP Requirements How SharePoint-Based QMS Helps
Organizational Structure and Data Integrity
  • Role-based access and multi-level permissions help organizations maintain organizational hierarchies and only authorized personnel have access to specific documents and data.
Standard Operating Procedure (SOPs)
  • Centralized storage with added features like versioning, metadata tagging, and more to manage, access, and control SOPs.
Equipment Calibration and Maintenance
  • Workflows can be configured to send reminders for calibration schedules and maintenance tasks. It helps maintain logs that can be stored centrally ensuring they are accessible for audits.
Training
  • Easily create training workflows, assign courses, track progress, employee training schedules, and maintain training history.
Audit Trails
  • Configure dedicated module to record all document actions such as who accessed, modified, or approved document and when, ensuring traceability and compliance.
Quality Assurance
  • Configure workflows, alerts, and notifications for prompt quality checks, reports, and reviews ensuring ongoing compliance.

ISO 22000

ISO 22000 is an internationally recognized standard for a food safety management system. It primarily enables organizations involved in the food supply chain to identify, prevent, and control food safety hazards, ensuring that the food is safe for consumption. It combines the key elements of ISO 9001 and HACCP principles to offer a structured approach to managing food safety and quality in line with global standards.

ISO 22000 compliance is mandatory for industries involved in food processing and manufacturing, agriculture and farming, food packaging, and food transport and logistics. Apart from the leadership and commitment that demands features like flawless communication and collaboration, it focuses on a few core aspects, including risk management, documentation and record control, operational control, performance evaluation, and continuous improvement.

ISO 22000 Requirements How SharePoint-Based QMS Helps
Risk Management (HACCP and Hazard Analysis)
  • Workflow automation to streamline the creation, approval, and monitoring of HACCP plans. Users can configure dedicated risk management modules to document identified hazards, their associated risks, and control measures.
Documentation and Record Control
  • Version control, structured document libraries, and audit trails to track changes and log actions for better record management.
Internal and External Communication
  • Integrated communication tools and secure external portals with email notifications and collaborative tools to facilitate seamless communication.
Operational Control
  • It offers automated workflows and corrective action tracking, and creation of standardized templates and checklists to clearly define and monitor food safety, such as supplier evaluations, inspections, and quality checks.
Performance Evaluation
  • Performance dashboards, audit management, and centralized audit records to report track performance and demonstrate compliance during inspections.
Traceability
  • Centralized data to manage supplier details, batch information, and inspection reports along with metadata tagging and automated workflow can help track products and manage effective recalls.

OSHA Compliance

Occupational Safety and Health Administration (OSHA) is a regulatory body under the U.S. Department of Labor with a mission to ensure safe and healthy working conditions for employees. OSHA compliance intends to set and enforce workplace safety standards, provide employees with adequate training and education, and help organizations with compliance.

OSHA Compliance is mandatory in industries including manufacturing, construction, healthcare, warehouse and logistics, oil and gas, agriculture, and many more.

OSHA Requirement How a SharePoint-Based QMS Helps
Document Management and Control
  • Centralized and secure document repositories with version control, metadata, and permission-based access to systematically store and manage safety manuals, SOPs, and emergency plans.
Training and Certification Tracking
  • Dedicated training management module with automated workflows and notifications to store, manage, and track training records, employee training certifications, and training resources.
Incident Reporting and Audit Trails
  • Easily automate incident reporting workflow from reporting to implementing corrective actions and resolutions. It helps users record each stage, activity, and decisions for better incident management.
Workflow Automation
  • Automated workflows to streamline safety inspections, corrective actions, and follow-ups with real-time notifications and task tracking feature.
Risk Assessment and Hazard Tracking
  • Supports custom risk assessment forms to log hazards. Tracks mitigation actions and sends alerts for unresolved risks.
Emergency Preparedness
  • Systematically store, retrieve, manage, and share emergency action plans, and track emergency drills and employee participation through workflows and dashboards.
Data Integrity and Retention
  • Ensures secure data storage with permission controls. Configures retention policies to meet OSHA's recordkeeping requirements.
Reporting and Analytics
  • Integrated with Power BI, users can leverage a SharePoint-based QMS to create powerful dashboards to provide insights into safety data, incident trends, and compliance metrics, supporting proactive decision-making.
Regulatory Updates and Communication
  • Stores compliance updates and ensures that your employees have access to the latest OSHA guidelines and automates dissemination of updates across teams.
Employee Safety Engagement
  • Users can create portals for employees to report safety concerns, review procedures, and access training resources to facilitate a safety-first culture.

ISO/IEC 27001

ISO/IEC 27001, jointly published and regulated by International Organization for Standards (ISO) and International Electrotechnical Commission (IEC) is a clearly outlined framework to help organizations manage and protect sensitive information, ensuring its integrity, confidentiality, and availability.

The three critical aspects covered by ISO/IEC 27001 ensures that:

  • The information is accessible only to authorized personnel.
  • Safeguarding the accuracy and completeness of data.
  • Authorized users have access to information when required.

While ISO/IEC 27001 is not legally mandated for all industries, it is strongly recommended for industries including finance and banking, healthcare, IT and cloud services, governance and defense, energy and utilities, etc.

ISO/IEC 27001 Requirements How a SharePoint-Based QMS Helps
Document Control
  • Secure document libraries with version control and document tagging to centralize and manage policies and procedures while helping organizations maintain document integrity and prevent unauthorized edits.
Access Control
  • Role-based access, multi-factor authentication, and permissions ensure only authorized personnel can access sensitive data.
Risk Management
  • Configure separate risk management module to register risks and automate risk management workflows for streamlined submission, review, and approval of risks documentation.
Audit Trails
  • Features like audit logging track user actions, such as document access, edits, and deletions, to securely store audit records for compliance during internal and external audits.
Electronic Records Management
  • Users can outline records retention policies ensuring secure document storage and archival. Document expiration and deletion policies can be created and automated to comply with data retention regulations.
Business Continuity and Backup
  • It offers a cloud-based platform to provide backups, ensuring business continuity in case of system failures and data loss.
Supplier Management
  • Dedicated supplier management module to store, manage, and access supplier documentation, contracts, and compliance records.

CMMI

Capability Maturity Model Integration (CMMI) is a globally recognized framework for ensuring process improvement, higher quality, and lower risk in organizational processes and workflows. As a regulatory requirement, it defines five maturity levels that help organizations achieve operational excellence, starting with process management and ending with process optimization.

CMMI framework is often required by industries involved in manufacturing, software development, aerospace, automotive, healthcare, pharmaceuticals, banking, etc. By leveraging a SharePoint-based QMS that can be configured to meet compliance requirements, organizations can efficiently achieve process standardization, quality assurance, document control, and compliance monitoring.

CMMI Requirement How SharePoint-based QMS Supports CMMI Compliance
Process Documentation
  • Centralized repository for storing SOPs, policies, and templates. Version control ensures accuracy and consistency.
Standardized Workflows
  • Automates workflows for approvals, reviews, and change management. Ensures process standardization and alignment to comply with CMMI best practices.
Knowledge Management
  • Offers centralized repositories to store, manage, co-author, share, and access knowledge documents.
Training and Competency Records
  • Maintains comprehensive records of employee training and certifications. Automated training workflows and reminders to schedule, manage, and track employee training.
Performance Management
  • SharePoint QMS with Power BI integration empowers users to create analytics dashboards to track KPIs, project progress, and process performance.
Compliance Monitoring
  • Configure dedicated compliance dashboards to provide visibility into process adherence and highlight deviations. Leveraging automated notifications to address gaps in compliance quickly.
Quality Assurance
  • Incorporates quality checks at critical process stages through automated workflows. It helps track non-conformance reports and CAPA records, ensuring compliance with quality assurance requirements.
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