Our Expertise

QACV Consulting has the knowledge and expertise to bring your company into compliance with a variety of services that can be specifically tailored to your unique company needs.
Audits

 

QACV is a full service consulting firm that specializes in GxP services including auditing services such as :

  • Data Integrity Assessments

  • GLP Facility Audits

  • GCP Audits, including Central Laboratories, IRBs, CROs, Trial Master Files, Investigator Sites, Sponsors

  • Internal GMP Audits

  • Contract Manufacturers, Laboratories, and Packagers

  • Excipient Supplier Audits

  • Computer Validation Audits

  • Software Vendor Audit

  • Hosted Services Audits

 

 

Computer System Validation

 

Development and Implementation of Computer Systems Compliance and Computer Systems Validation Support, including:

  • Validation Plans

  • User Requirements Specifications

  • System Specifications (Functional, Configuration, etc)

  • Installation, Operational, and Performance Qualification

  • Validation Reporting

Data Integrity Compliance

 

Data Integrity Programs, Training, and Assessments

  • Data Integrity Training

  • Data Integrity Assessments for both electronic and paper processes

  • Development of data integrity programs, policies, and procedures

  • Data process flows

  • Data Integrity gap analysis of systems.

Training

 

QACV training programs and courses include:

  • Good Manufacturing Practices

  • Audit Conduct

  • Product Complaint Handling

  • Computer Validation

  • 21 CFR Part 11

  • Good Laboratory Practices

 

  • Good Clinical Practices

 

Quality System Workshops

Implement and improve your Quality Systems by participating in workshops:

  • Workshops allow your organization to own and optimize the Quality System being implemented or improved within your organization

  • The ideal alternative to buying generic SOP's on the internet and hiring expensive consulting firms to impose systems on your organization

 

QACV leads your personnel in defining and implementing Quality Systems including all of the items listed below and many more:

  • Training programs

  • Warehouse Management Operations

  • Computer System Compliance and Validation

  • Document Management

  • Audit Programs

  • Quality Management Systems

 

GDPR & Security Assessments & Training

 

Cyber Security

Cyber Security is the protection of computer systems and networks from the theft of, damage of or disruption of the hardware, software or electronic data.

QACV’s consulting services provide the development and implementation of Cyber Security Programs and Cyber Security Support, including:

• Cyber Security Policies and Procedures

• Cyber Security Training and Awareness for End Users and IT Support personnel

• Incident Preparedness and Response

• Network Security Controls

• AntiVirus / AntiMalware Solutions

• End Point Protection

• Risk Assessment of 3rd Party Vendors

• Assess risk versus controls to comply with HIPPA, GDPR, ISO27002, NIST 800-53 and PCI Data Security Standards (PCI DSS) regulations.

• Remediation of Risks Post Breach

 

Data Privacy

Data Privacy is related to the proper handling of data, such as how it is collected, used, maintained and deleted.

QACV consultants will review and assess the technical processes and procedures for Data Privacy to ensure compliance to Data Privacy regulations (GDPR, CCPA and other global and domestic privacy regulations).  These reviews include:

• Encryption requirements

• Multi-factor Authentication

• Key Management

• Back Up and Recovery procedures

• Deletion of Data

 

Risk Management

 

Project Management

 

Facilitate risk assessment and FMEA processes to proactively identify potential risks to your processes and systems, and manage risk mitigation activities.

Management of compliance projects to assure your projects stay on track and implemented efficiently while meeting business and quality objectives.

Call 1+(610) 442-2250

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© 2015-2018 by QACV Consulting

 

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