For companies that need to validate their document management systems, it is often difficult to obtain validation “ducks in a row.” The validation process is a difficult question, especially if one has begun in the company on a project prior to validation. To validate the document management software systems, companies can effectively consultations, often provided by the manufacturer of the software request, or ask the software provider if there are other options. A seller of high-level validation services and solutions, one or more of the following services:

Best Practices Validation Services
During the validation of their document management systems, some customers prefer to implement protocols and validation of products independently. If this is your preference might be a validation team best practices advice to help you organize your project validation, gaps, to ensure the proper implementation and successful implementation.

individual consultation for your document management systems validation project would comprise:

• Planning for the validation
• Development process / consultation
• Protocol Development Training / Consulting
• systems for compliance audits
• Review third of the customer documentation / Materials Management Project

Records Management System Validation Training
If your organization is new to the validation, a validation of training just what you need to get up to speed. If the actual price, run by the FDA and GAMP ® regulations and validation methods of automated systems, applications, processes, or it is a good idea. A two or three days is usually enough cover to this type of information and familiarize staff with appropriate methods for planning and implementing a records management system validation project. Ongoing discussions should be avoided include information on common mistakes when implementing the project validation.

Enforcement Services Protocol

If you do not want to go alone, an adviser to a group of Validation Services lead your team through the test all the features and functions of application systems for document management. The minutes for the system should be based on industry standards and offer full traceability of definitions depending on the specifications of the product functional requirements. They contain all the necessary guidelines to the management systems complete validation documents and re-testing for system upgrades.

Protocol implementation services for your document management systems can be:

Performance IQ
Installation Services implementation of the qualification can be performed either remotely via a secure Internet connection or website. In each run, the consultants train your staff in the preparation and installation of server hardware to ensure that the requirements for operating systems.

OQ Execution
The operational implementation of the qualification can be performed manually based on your site using industry standard protocols and test the various functions and features of document management systems. Validation consultant can also help you direct your staff for the operation of protocol test during the entire process OQ perform. The end of the test protocols ready for testing degree detailed screenshots and collect the objective evidence that the interpretation for the functional design.

PQ execution
Services performance evaluation of the performance (PQ), a detailed protocol to use your custom PQ based systems. Validation consultants can also help the command execution protocol test, the overall direction and leadership in the implementation of records and compliance testing.

Developing a Custom Protocol
Validation consultants can help you with the full development of customer-specific protocols of professional qualifications. Consultants begin on the development process through the collection of on-site configuration and operating procedures / work instructions for the implementation of document management systems. The collected data is then used to create, a fundamental protocol data integrity, security and integrity of the electronic authorization covers integrity checking processes recover for record creation, approval and secure. Test sites and supports multiple users simultaneously running operations, proves the stability and integrity of both systems use aggregate. This service is normally charged by the process of PQ to propose a complete solution, Performance Qualification.

Marci Crane is editor of the MasterControl GxP Lifeline Publications, Inc. is MasterControl in Salt Lake City, UT headquarters. For more information on document management systems and all MasterControl validation services and solutions mentioned above, please do not hesitate to contact MasterControl.

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