GxP Strategic Consulting for Compliance

As your strategic partner, CyberSecOp brings years of experience and industry knowledge to the process of recommending the ideal technology solution for your organization. We take the lead in analyzing your current systems, architecture, needs, and capabilities as well as in proposing a technology direction, scope, project planning and driving compliance with regulations such as FINRA and Sarbanes Oxley (SOX).

CyberSecOp helps organizations in the following industries food, drugs, medical devices and cosmetics to comply with SOC GxP, GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.

GxP is an established standard regulated by the Food and Drug Administration (FDA) and encompasses different standards recognized as: G – stands for “Good” P – stands for “Practice” x – variable depending on the application

GxP Compliance Consulting & Quality Auditing

CyberSecOp assist businesses and institutions with stringent process and regulatory requirements using our solutions and services.

CyberSecOp will preform a quality system regulation (QSR) gap analysis

Security controls

  • Encryption (at Rest and in Transit)

  • Network Encryption

  • Advance Intrusion Detection

  • Advance Antivirus

Strategic Consulting for Compliance

  • Addressing Deviation Investigations and Reports

  • On-site GMP, GCP and GLP Training including Training the Trainer

  • Preparation and implementation of Standard Operating Procedures (SOPs) and Validation Protocols

  • Preparation and review of Batch Records

  • Providing Annual Product Review Services and data Trend Analysis

  • Development and Implementation of product labeling and packaging programs

  • Development of justifiable specifications for the evaluation of in-process and final product testing

  • Bridge the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities

GAP Assessment

  • Review Controls

  • Review Policy and procedures

  • Information Security assessments

  • Testing of currently controls

GxP Validation Process

  • Define GxP guidelines based on on QSR

  • Define technology road map to remediate gaps

  • Build and construction

  • Provide computer validation service

  • System testing

  • Roles and Responsibilities

  • Audit Trail

  • Business continuity

  • Write validation plans and summary reports for your systems

  • Identify system relevance, system and vendor risk, and interpret audit findings

CyberSecOp will assit in the Development and implementation of Core Quality Systems, for example, Change Control, Training, Planned Preventative Maintenance Schedules, Validation, Documentation, and Out-of Specifications.

GXP compliance services & solutions

We offer an integrated portfolio of consultancy services and software products for ensuring GxP compliance of business processes and resources, including facilities, utilities, equipment and IT. Furthermore, we offer IT services and solutions to establish and maintain a GxP compliant and reliable IT infrastructure and application landscape for continuous business operations. Our portfolio provides a full solutions for ensuring permanent inspection readiness in an efficient way.