Synergy for Quality

approach

Compliance Approach

Admin - 21 Sep 2016

We base our approach to compliance on the current industry guidance and methods and we strive to understand the fundamentals of everything that we do, applying our approach in the appropriate method to provide a solution. Our services are tailored for the specific needs of our clients and each project. Some specific areas that we assist our clients’ needs:

Auditing  We first outline the purpose of the audit and assemble a plan identifying roles and activities. We will probe and evaluate the audited system. As part of our audit, we identify areas of greatest risk and quality impact and we will work with you to develop immediate corrections, preventive measures, and a remediation plan.

Validation Project Planning  We begin by assessing what the regulatory implications as they relate to a GMP facility or system. A User Requirements document may be developed at this stage that describes the intent and expectations of the project outcome. Systems are defined, how they relate and will impact each other, and boundaries are reasonably thought out, to simplify the validation effort.

Risk Assessment  The risks that a system has to product quality is assessed based on purpose, relation to other systems, and impact to the final product. Evaluation of risk is applied to our approaches in audits and system validation and is based on sound logic and science. For validation projects, systems are assessed as to whether the system has direct impact (critical), indirect impact, or no impact to the product. Direct impact systems have critical requirements or functions that must be qualified. Indirect impact and no impact systems do not require qualification, but should be commissioned.

Design Review  Critical systems (direct impact) should have a specification to define the critical requirements. This serves as a specification to establish design reviews and its subsequent qualification. The design review is performed to establish critical systems are designed for impact.

Testing Documentation Assembly  Qualification testing protocols are assembled in accordance with regulatory expectations and the critical requirements. Components of systems are assessed for critically and qualified. Supporting commissioning documentation can be assembled simultaneously.

Execution of Validation Documentation Validation documentation begins execution during installation phases and continues until verification of operational and performance features have been verified. With proper change management in place, installation qualification activities can be performed simultaneous with commissioning.

Resolution of Discrepancies  Resolution of testing that fails to satisfy acceptance criteria, or discrepancies,  during the execution of qualification is an important part of the qualification process. Emphasis is placed on documenting nature of the testing failure, and tracking necessary corrective actions assuring appropriate closure during project execution.

Verification of Completion of Validation Activities  System acceptance reports will summarize the validation activities and verify that all acceptance criteria have been satisfied within a matrix. This provides assurance to the system stake holders that all testing that was intended has been performed satisfactorily and is ready to be released.