Validation Services

Strategic Maintenance Solutions is pleased to announce the addition of validation-consulting services to its existing professional service offerings. This new service allows clients to meet CMMS implementation goals utilizing a single professional service provider. Strategic Maintenance Solutions employs a staff of validation consultants with extensive experience in Pharmaceutical Validation. The industry leading CMMS implementation consultants of Strategic Maintenance Solutions now work with the seasoned validation staff to implement all major CMMS applications while meeting regulatory requirements.

Our approach for validation is based on GAMP, cGMPs and the latest developments in 21 CFR Part 11 (such as the recent risk-based approach presented by the FDA). Existing client CMMS or ERP life cycle documentation can be revised by our staff to incorporate specific information for the particular project. The project schedule, resources, equipment and deliverables are presented as part of Validation Plan and Implementation Plan, which are prepared in coordination with the client.

Strategic Maintenance Solutions can prepare and execute all system development life cycle (SDLC) documents . Customized SDLC documentation packages may include User/Functional Requirement Specifications, Technical Design Specifications, Validation and Implementation Plan, IQ/OQ/PQ Protocols and reports, and Requirements Traceability documents. All SDLC documents are written in collaboration with the designated client department personnel. In addition, we can assist in the preparation of documentation that supports the ongoing validation of the system: such as SOPs for computer system change control (hardware/software), system administration (administrative tasks and data management), system operation, data backup, data archiving and retrieval, disaster recovery and related training materials.

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