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
Encryption (at Rest and in Transit)
Advance Intrusion Detection
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
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
Roles and Responsibilities
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.