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.
