Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

The policies, procedures and templates are priced at a fraction of the cost to develop such documents. Customization services are also available.

If you are interested in purchasing documents, please contact BPA

Procedure Title Purpose Comments
Validation Requirements for Computer Systems
To define high-level requirements for the validation of different types computer systems
This procedure lays out the big picture for computer system validation. It is the link between the overall validation policy and specifics for different types of computer systems
Lifecycle for the Selection, Implementation, Validation and Use of Off-the-Shelf Computer Systems To define the requirements and process for the development, selection, validation and use of computer systems with the purposes of assuring quality and complying with regulations. This is the main procedure for the control of computer systems. It includes the entire lifecycle from planning to retirement. The deliverables from the lifecycle form the validation record.
Requirements for Computer System Validation Plans, Protocols and Reports To describe the content requirements for computer system validation plans, protocols, and reports, including the validation plan for a system, the DQ, IQ, OQ and PQ validation protocols, protocol reports and the final validation report. None.

Change Control for Validated Systems

To define the procedure for making changes to validated systems. None.
Computer System Project Proposal To provide a computer system project proposal form and instructions for its completion. The computer system project proposal is completed by the system owner with input from validation & IT. It is the basis for determining if Part 11 applies to a new system, and the risks and cost associated with the system. The proposal is approved to allow the project to proceed.
Vendor Qualification and Management To define the process for qualifying hardware and software vendors of systems that can impact the quality of products, for the annual review of vendor performance and for addressing performance issues. The scope of this procedure does not include the qualification and management of vendors for custom software or system integration. The procedure can be used with a formal vendor corrective action system.
Vendor audit checklist To provide a form for conducting an audit of a software vendor. None.
Validation of Spreadsheets To provide a process for the validation of spreadsheets. This procedure applies the lifecycle in VAL002 to the validation of spreadsheets. A separate procedure is written for spreadsheets in order to simplify & clarify the application of the lifecycle.
Protocol Amendment Reports To provide a form for amending a validation protocol. None.
Protocol Variance Reports To provide a form for recording and resolving variances that occur during the execution of a protocol. A variance is any difference between actual results and expected results. The differences can be due to protocol or system errors.
Writing a Validation Plan To describe the content of a validation plan and responsibilities for creating it. This work instruction provides more detail than is given in VAL003.
Code Review Criteria To define the process for and the criteria to be used in reviewing code for adequate documentation. None.
Creating User and Administrative Procedures for Software Applications To provide requirements for user and administrative procedures The requirements defined in this procedure include appropriate Part 11 procedural requirements
Guidance - Items to Evaluate in an IQ, OQ, and PQ for a Computer System To provide guidance on what to test in the IQ, OQ, and PQ protocols. None.
Guidance - Suggested Approaches to Validation Lifecycle Activities Based of System Risk To provide guidance on the performance of lifecycle activities based on the risk level of the system The document includes guidance for off-the-shelf, configurable and custom software