Compliance Solutions

Operations

Sensyo offer a complete range of quality and regulatory compliance support to manufacturing, packaging, quality assurance, engineering, and quality control organisations.

Regulatory Compliance

Sensyo assists clients with GMP reviews of new facility design, evaluation of existing operations, cGMP audits of facilities/suppliers and FDA regulatory consulting.

Master Planning

Sensyo helps clients during the earliest phases of grass roots projects, and during strategic shifts at existing sites through creative Master Planning studies. In addition, Sensyo performs traffic studies, survey and incorporates local permitting and zoning requirements, provides master plans that comply with state and local codes, and presents those plans to local authorities on behalf of clients.

Process Design

Sensyo work processes include the use of smart tools and intelligent P&IDs that are integrated with equipment lists, datasheets and specifications. We have expertise with industry-specific unit operations, high purity piping systems, and state-of-the-art process automation and controls.

Facility Design

Sensyo provides a full range of facility design services, including architecture, civil, structural, HVAC, plumbing, fire protection and electrical for state-of-the-art cGMP facilities. Our philosophy is that facility design is fully integrated with the process design through all the phases of the project.

Procurement

Sensyo provides services for vendor and subcontractor qualification, bid preparation and analysis, and terms negotiation in the procurement of GMP equipment and services.

Construction Management

Sensyo has or has access to experienced professionals trained in construction practices required for GMP facilities and pharmaceutical clean room construction. We provide pre-construction services, site management, planning, cost control, value engineering, and quality assurance functions.

Commissioning

Sensyo develops, plans and executes protocols for commissioning for GMP and non-GMP pharmaceutical industry facilities. We have current experience with implementation of ISPE Commissioning Baseline guide recommendations.

Validation

Sensyo develops validation master plans, plans and schedule validation projects, writes SOP's, and prepares and executes IQ, OQ, and PQ protocols. In addition, Sensyo also provides GMP training and certification and pre-FDA plant inspections. We have developed and proven a methodology for efficient integration of commissioning and validation activities in accordance with international regulatory and industry guidelines.

Drafting of Validation Report(s)

The clear and concise drafting of validation reports is crucial because the results of each part or of the entire validation are the first inspected documents and also serve as reference in the conformity or non-conformity of a system.

Through their experience acquired on the system or on similar systems, Sensyo consultants are capable of finding workarounds for detected faults and successfully tackling validation incidents. The reports are optimized in a manner that subsequently makes them easy to read and accessible to all.

Drafting SOP and SWI Procedures and Instructions

A process or a computerized system is made up not only of ingredient, software, hardware and a basic environment, but also of users and related procedures. Therefore, a process or a computerized system can be compliant only if the procedures and training processes comply.

Moreover, we offer to draft or help you in drafting the following, minimum number of procedures to ensure the proper and continuous functioning of the process: usage, special contingency plan, backing-up and restoring and specific archiving, access and security control.

Drafting of these procedures involves not only a good knowledge of the processes and their constraints, but also the adaptation of these processes in the context of your company.

Training

Training on the system and procedures is required in order to complete the compliance of the system in its entirety. Thus, Sensyo trains the systems representatives, through its training services and its proven knowledge in policies and procedures.

Maintaining Validated Status

The processes notified through procedures including usage, specific contingency plan, backing-up and restoring and specific archiving, access and security control make it possible to guarantee the reliability of the system over time and anticipate risks.

Decommissioning

Before decommissioning an equipment, a facility, a utility or a computerized system, several questions need to be asked especially in regards to validation status and archiving compliance standards.

For this reason and for providing the company a control of its processes throughout the life cycle of the computerized system, Sensyo has set up special services concerning data migration and electronic archiving.

Process Control

The Process Control team is an engineering and design group with expertise in cGMP computerized control systems and the structured Software Development Life Cycle (SDLC) methodologies. This group provides assistance in the development and documentation of software quality assurance programs and subsequent SDLC phases based on recognized industry standards such as IEEE, ANSI, ISA and ISO.

To read more about Sensyo specific capabilities and services, please go to Sensyo sample list of services and systems experience.