Template Packages

This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.

This package features 34 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within a Medical Device organization.

This template package features a universal IQ/OQ Protocol template that provides a ready-to-populate document to generate an IQ, OQ, or IOQ in the pharma or biotech industry.

This package features a universal audit / inspection preparation checklist template which provides a comprehensive list of tasks and activities that should be performed by multiple departments in preparation for a regulatory inspection or audit.

This template package features a universal Change Management Form Template that provides a method for formally tracking and approving changes in a project which are outside of the approved project charter or project plan.

This template package features a universal Communication Plan Template that provides a method for clearly defining the communication responsibilities, rules, vehicles, and frequency for any project.

This template package features three universal Kickoff Meeting Agenda Templates that provide the tools to effectively facilitate and manage a 2 hour, 4 hour, or 8 hour long Kickoff Meeting for any project.

This template package features a universal Project Closeout Form Template that provides a method for formally closing out a project, including performing a Lessons Learned, Risk Plan review, and project file archival.

This template package features a universal RACI Diagram Template that provides a method for clearly communicating roles and responsibilities on a team during any project.

This package features a standard procedure which outlines the approach for managing risk within any project. Three universal templates to support the creation of a plan for managing risks are also provided.

This template package features a universal Stakeholder Analysis Template that can be used to outline those individuals and/or organizations who may impact or be impacted by a project.

This package features a universal Weighted Grid Analysis Tool that provides a method for comparing multiple project options.

This template package features a universal action item list and decision register template that can be used to easily manage tasks and responsibility for any project or meeting.

This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.

This template package features two universal meeting agenda and meeting minutes templates that can be used to effectively facilitate and manage any meeting.

This template package features a universal Project Charter template with example text that can be used for any project requiring a Project Charter.

This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.

This template package features a universal Training Attendance Sheet template that can be used to properly track and document the attendees of any training course.

This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.

This template package features a universal Biologic Material Transfer Log template that can be used to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The log provides basic information on the origin, nature, and key biological and safety properties of the materials in question.

This template package features a universal Certificate of Translation template that can be used to properly document and certify any documents that require translation.

This template package features a universal Change Management template that can be used to provide information on both contemplated and actual modifications to the process and/or its components in a controlled and documented manner.

This template package features a universal Equipment List template that can be used to provide the most complete information on all critical and auxiliary systems for the transferred manufacturing process and associated testing.

This template package features a universal Interview Evaluation template that can be used to conduct and rate any interview for potential employment.

This template package features a universal material receipt and lot testing template that can be used for receiving raw materials and executing incoming testing.

This template package features a universal project roster template that includes all of the pertinent information that should be captured in any project roster.

This template package features a universal Quality Plan template with example text that can be integrated into any documentation system and used to define the quality practices, resources, and activities relevant to a process.

This template package features a universal Solution Formulation template that can be used to outline the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.

This template package features a universal SOP template that can be integrated into any documentation system and used for formatting any policy, process, or procedure document.

This template package features a universal traceability matrix template that provides a ready-to-populate document and spreadsheet to generate a trace matrix for any system validation.

This template package features a comprehensive outline of the information required in a User Requirements Specification for the Biotechnology, Medical Device or Pharmaceutical industries. It includes sections for process overview, design and construction, operational requirements, automation requirements, safety, acceptance and delivery, and documentation. Suggested technical content is also included throughout the template.