GXP COMPLIANCE CONSULTING SERVICES

We assist pharmaceutical and healthcare manufactures with GXP readiness and compliance.

Are you ready to become GxP Compliant? with our GxP consulting services we can help you get there faster.

GxP Compliance Strategic Consulting

As your strategic partner, CyberSecOp brings years of experience and industry knowledge to the process of recommending the ideal technology solution for your organization. Our expertise include GXP compliance, advising on operational, managing interactions with regulatory agencies, and preparation and evaluation of SOPs, technical documents to comply with regulatory requirements. We are experts the the following arears Design, Engineering, GMP, QA and Validation services to the Medicinal Cannabis, Medical Device, Pharmaceutical and Veterinary manufacturing industries so that they can meet the required relevant regulatory standards.

CyberSecOp helps organizations in the following industries food, drugs, medical devices and cosmetics to comply with 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 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

GPx & GMP GAP Assessment

  • Review Controls

  • Review Policy and procedures

  • Information Security assessments

  • Testing of currently controls

GPx & GMP 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

  • Use an Audit Trail to log all system activities and reason why they were performed

  • Taking ownership of data and accountability for data integrity

  • Access rights and privileges based on “need to know” and “least privilege” and Segregation of Duties.

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

GPX & GMP 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.