One of our validation packages. A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. The ideal package for the busy laboratory technician to follow. Simplicity personified; a Validation Plan (VP) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance. A well designed User Requirements Specification (URS) to detail the functionality of the equipment under qualification and to maintain the traceability of all verifications. A Design Qualification (DQ) that will ensure that your individual laboratory equipment’s design is adequate to execute their allotted tasks. A Validation Risk Assessment (VRA) to ensure your validation scope is set in line with the regulatory requirements for this class of equipment. Finally the redoubtable fully detailed and interactive Installation (IQ), Operational (OQ) and Performance Qualification (PQ) Protocols.

A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. Ideal for the busy laboratory technician to follow. Simplicity personified; a Validation Plan (VP) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance.

Simplicity personified; a well designed User Requirements Specification (URS) to detail the functionality of the equipment under qualification and to maintain the traceability of all verifications.

A properly designed and precisely executed Validation Risk Assessment (VRA) analysis has proved over and over again to be key to the expedient completion of any FDA, WHO and or EU compliant; risk based validation project. Our latest issue of this VRA document (issue 11) reflects these principles and also incorporates the very latest in regulatory mandates and legislative guidance document comments. Our Validation Risk Assessment (VRA) takes you through this assessment process and enables you to make a documented and justified decision as to the level of validation each piece of equipment will receive. This fulfills your obligation to ensure that all software is assessed, as to FLCV applicability.

Design Qualification is used at the stage where a design that has been developed from the, VMP / URS and other Health and Safety Guidelines has to be reviewed competent persons to ensure that the design; if built, will satisfy the detailed specified requirements contained within the URS and all other applicable cGMP rules, regulations and guidelines. This is where the majority of major project problems are manufactured, not obvious immediately, but materializing later in the project time line.

A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. The ideal package for the busy laboratory technician to follow. Simplicity personified; Finally the redoubtable fully detailed and interactive Installation Qualification (IQ) Protocol.

Simplicity personified; a Validation Installation Qualification (IQ) to set out scopes, responsibilities, time lines and methodologies, in a clear simple way that will not only please your regulators but will ensure compliance. THe fully detailed and interactive Operational Qualification (OQ) Protocols.

A much used sequence of interrelated, cross referenced and sequential FDA mandated documents. The ideal completion to any package for the busy laboratory technician to follow. Simplicity personified; a Validation Performance Qualification (PQ).