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Documentation Remediation

Blog post by Stephanie Simmons, Senior Validation/Project Engineer

For systems that we develop, Superior Controls has a disciplined approach in providing complete and consistent delivery of documentation.  We use ISPE’s Good Automated Manufacturing Practice (GAMP) guidelines which is considered a benchmark in the Pharmaceutical and Biotech Industries.  The documents provided are structured to allow our customers to easily update and maintain the documentation over the lifecycle of the system that they describe.

Because of the expertise and experience of the engineers in our Validation/Project Engineering Group, Superior Controls also provides solutions for customers who require lifecycle documentation remediation for existing systems.

Remediation is necessary when the customer’s documentation requirements, usually based on GAMP guidelines, are not met and the lifecycle documentation does not accurately describe the automated control system’s configuration or operation.  Key documents may be missing, incomplete, or are outdated with respect to changes made to the automated control system.  Often, gaps in documentation are identified during an audit of the customer’s system.

Prior to remediation, an initial assessment is made with the customer, identifying what is needed to meet GAMP 5 or customer SOP requirements, and the level of remediation that is required.  Typically all or some of the following lifecycle documents may need to be developed or updated: User Requirements Specification (URS), Functional Specification (FS), Hardware Design Specification (HDS), Software Design Specification (SDS), and Traceability Matrix (TM).  Sometimes, a Software Validation Project Plan and Site Acceptance Test (SAT) also may need to be developed.

During remediation, engineers from the Validation/Project Engineering Group will work together with one or more project engineers at Superior Controls who have experience with the software applications and/or hardware components used in the system identified.  Members of the team review any existing documentation and source code, meet with subject matter experts, and may observe the operation of the equipment.  Superior Controls Validation/Project engineers have the engineering experience to get the information needed to reverse engineer the system and the technical writing ability to document the automated control system clearly and accurately.

Our automation systems documentation effort includes resource management and scheduling.  In order to be time efficient and to facilitate the review and approval process, our Validation/Project engineers may schedule working meetings at strategic intervals with the customer’s team.  We go through the documents during these meetings, making sure we share the same understanding of the user requirements and system functionality, and make edits real time with the agreement of key stakeholders.

If validation testing is needed for the remediated system, Superior Controls also may develop the required test protocols and provide engineering support to assist the customer in test execution.