EVC consultants can assist in the development and/or assessment of plant SOPs including those related to training, calibration programs, preventive maintenance, change control, CAPA, Investigations, validation, documentation review, failure investigations and out of specifications. EVC also supplies advice and research to assist in the creation and implementation of vendor and internal audits.

In terms of qualification/validations for new facilities, EVC’s experts employ the life cycle concept, integrating the validation process with engineering, design, and construction. The steps involved in this process include: technology transfer, conceptual design, engineering, design review, procurement, construction, commissioning, qualification and validation maintenance. Validation spans: master planning, protocol development, construction/installation review, FAT/SAT’s, Commissioning, IQ/OQ/PQ, summary reports, and regulatory agency review. Experience has shown that integration of cGMP compliance and validation early in any project minimizes validation costs and enhances operational efficiency.

For existing (legacy) facilities, equipment and processes, EVC will conduct an assessment of your operation including a gap analysis/risk assessment of your deviations/areas for improvement. We will recommend an action plan and guide you through the process of implementation.

We are worldwide-recognized speakers at pharmaceutical quality, compliance and validation related conferences and provide the same service on-site on trainings that could be customized and/or tailored to your particular needs and applications. Areas include Cleaning Validation, Process Validation, Facility/Utilities Qualifications, Quality Systems such as Change Control, Calibrations, OOS/Failure Investigations, Conducting Audits and many more.

Our philosophy is based on the commitment to provide value-added quality systems, validation and cGMP compliance consulting services including audits, training, assessments, procedures and hands-on support in order to enable the client to develop and maintain compliant and qualified/validated operations.