If your company requires a validated software product, DocXellent provides electronic document control options. Whether your company operates under the guidelines of FDA 21 CFR Part11, FDA 21 CFR Part 820, ISO 9000, ISO 9001:2008, ISO 13485 or others, DocXellent and ensur have helped other organizations in your industry with software validation services to stand up strong to these regulatory bodies in an audit. Our software validation services provide industry standard services and products to meet all of your compliance and validation needs.
Our staff of validation experts have assisted many types and sizes of companies with software validation services. Whether you are a small start-up in the life sciences industry or a major global pharmaceutical conglomerate, we have been there with all aspects of your validation requirements. Whether your organization insists on doing it yourselves, requires assistance or complete turnkey validation services, DocXellent is there for you under any approach.
For new self-sufficient DocXellent customers who prefer to execute our authored protocols and validate ENSUR independently, our validation tool kit is all you need. If you don’t have the internal resources to dedicate to validating ENSUR, our remote software validation services is an option for you. If you require a hybrid approach requiring coordination between your company and DocXellent, let’s discuss your approach to make sure all the gaps are filled for a successful validation.
Our services include:
- IQ, OQ and PQ services
- Validated software planning
- Remote OQ validation services
- OQ scripts and validation documentation package
- PQ procedure development
- PQ procedure development consulting
- Remote IQ Execution Services. The Installation Qualification execution services with ensur are conducted remotely via secure Internet connections. Working with your IT resources, our application installation team will collaborate with your personnel in the inventory, installation and validation check of your server hardware to certify it meets the necessary requirements for your successful ensur system installation.
- Remote OQ Execution Services. The Operational Qualification execution services are conducted remotely from our location using DocXellent’s ensur OQ scripts to fully test and verify the functionality of ensur in your facility or facilities. Our OQ Validation consultant works with your company’s assigned personnel and performs the protocol test activities throughout the OQ process. Upon completion, the completed protocols, test notes, executed screen shots and any deviations and related documentation are sent to your assigned personnel and become evidence of the system performing to the functional design.
- PQ Execution. The Performance Qualification (PQ) development services include a customized PQ script detailing your intended ensur systems usage. The DocXellent validation services team works with your business process representative in the creation of the protocol test instructions, providing script generation and documentation.
Contact DocXellent for more information on compliance and validation services.