Engineering & Validation

Defining the User Requirements Specifications (URS) for facilities, Utilities and equipment.

Conceptual Design of manufacturing facilities and production lines including personnel, material and waste flow.
Design new facilities and redesign existing facilities in order to suit the GMP and operational needs.
Submitting the Design to the Ministry of Health (or other regulatory authority) to obtain the GMP approval.

The BOD document describes the basic concept of the facility/system and provides the required rationale for it.

Supporting the detailed design of critical utilities: HVAC systems, Clean rooms, PW, WFI, Pure Steam, Compressed Air, N2, CO2, O2, Ethanol and solvents supply.
Perform detailed design review for critical systems and participate in the design review process.

Perform GMP inspections during the Establishment phase of the facility to ensure the detailed design is met prior to handover.
Writing and performing commissioning protocols prior to the validation in order to ensure proper handover by the supplier.

Develop commercial scale process design.
Design of production lines including choosing the right equipment and utilities.
Supporting Tech Transfer.
Defining critical aspects of the process and design of the necessary means of control.

Writing SOP’s for operation, cleaning and maintenance of systems and equipment.

Computerized System Validation services for pharmaceutical and medical device companies.

Our CSV services are applicable for OTS (Off the Shelf) software applications that support your process controls; Non configured (GAMP 5, Category 3); Configured (GAMP5, Category 4) i.e., Priority/ QMS, and; Customized software (GAMP5, Category 5) i.e., SAP and spreadsheets validation such as Excel files.

Writing of CSV Policy and Supporting SOPs:

– SRS, Classification Assessment

– Software Risk assessment

– Deviation Handling

– Access Management

– ERES

– Change Control

– Backup and Restore

– Retirement

– Data Archiving and Retrieval

– Vendor Assessment

CSV services include writing documents and performing of:

– SRS/FRS- Learning your Software and defining system requirements and functional requirements

– Software Design Specification – Defining the software design specifications

– Authorization Matrix- Building Access Roles and responsibilities authorization

– Risk Analysis- analyzing software associated risks and risk prioritization and defining controls and measures for mitigation

– Validation Planning- Writing a Plan for your software validation activities with regards to the  validation scope,

    strategic and testing methodology, while using a risk-based approach.

– IQ, OQ, PQ templates and protocols- Customizing Validation testing templates for writing the IQ/OQ/PQ validation protocols.

– IQ, OQ, PQ execution- Performing the validation testing based on pre-approved protocols and documenting all validation results in real-time.

– Data Migration Plan qualification protocol and Report (where applicable)- Planning and writing the Data Migration Plan when transferring data

   from one system to another.

– Traceability Matrix-Gathering all validation data references from the requirement to testing level and assuring full coverage of the system requirements,

   risks and defined validation testing, deviation resolutions, and reports.

– Deviations Reports- Handling and resolving all deviations during the validation execution.

– Validation Summary Report- summarizing all of the validation activities and generating a final report which qualifies the system as valid and ready for use.

– CSV Training – Delivering of professional CSV training courses and presentations for your CSV team

Performing risk analysis in order to identify and mitigate all the risks within the facility/process/systems/equipment. The analysis supports the conceptual design and defines the extent and scope of the validation.

Identifying all validation activities within the manufacturing facility throughout the validation life cycle.
Defining the overall validation strategy and procedures. The outcome of this process is the validation plan of the facility.

Reviewing all the detailed design documents and specifications in order to verify compliance with the relevant regulatory requirements as well as the user specifications.

Writing all validation protocols, execution and writing validation reports for systems and equipment.
Coordinating all the activities involved in the validation process,managing the whole operation including subcontractors, deviation resolution and quality impact assessment.

Design and develop the process validation protocol and plan.
Accompany the execution and write the validation report.

Customized validation training courses for engineers and validation/engineering managers at all levels.

Preparing validation departments from a subjective point of view for external audits by FDA/MOH.
Performing mock audits / Gap analysis for engineering and validation departments.
Studying the existing activity of the department from an external point of view and preparing a gap analysis and mitigation plan.
Accompany the client through external audits.