Our Services

Title21 Software offers a range of services to ensure each client’s specific needs are met. All of our technicians have experience in the life sciences industries including pharmaceutical, medical device, blood banks, hospitals and food supplements. Before installation begins, our Professional Services team meets with key individuals inside the client site to discuss the goals for the software implementation, key milestones and deliverables, and target completion dates. Title21 Software can integrate with most ERP, MES, LIMS and similar legacy systems.

Our team will analyze the client’s existing quality systems and discuss what changes will optimize moving to an electronic system. Key quality processes are outlined and our team reviews the pre-installation guide with the client’s key process owners. Title21 Software assigns a project leader based on the needs of the customer. This will be the main contact for all questions, contacts and ongoing technical support once the implementation is complete.

Once installation begins, Title21 Software personnel will be on-site as well as working remotely via WebEx assisting in the creation of security groups, defect code lists, trend alerts, as well as configuring forms and workflow processes to meet the client’s specific needs. We will also begin the training of key IT personnel that will serve as the client-side administrators of the system.

If data migration of key documents, SOPs, drawings, specifications, technical reports, and other records is needed, our installation team has the experience to bring in tens of thousands of documents into the system with minimal disruption to the customer’s operations.

Title21 Software provides a comprehensive training program that speeds time to implementation. All training is conducted at the customer’s facility, reducing travel expenses and time away from work on the client side. Administrators’ training covers system set-up, configuration of forms and processes, adding personnel to security groups, and basic maintenance of the system. End-user training details the basic functions of the software including editing, approving and distribution of documents, creation of tasks and trend alerts, using the report tool and the workflow management tools. We also offer “train the trainer” programs for the read-only users of the software. On-going training is always available.

Validating electronic record-keeping systems is essential to meet the FDA regulation 21 CFR part 11. In addition to the extensive validation process undertaken prior to any software release, we can provide on-site validation services. Depending on your needs and resources, we will set up the appropriate test environment, prepare and execute the site validation protocol, collect objective test evidence, and provide you with a summary site validation report.

In order to ensure that customers have all the necessary help to use and maintain Quality Manger, Title21 Software Technical Services Group provides technical support. Support hours are 7:00 a.m. to 5:00 p.m. Pacific Standard Time (PST). Each customer site has a primary contact for support – the same project leader that oversaw the installation of the software. Customers may phone technical support directly or email their support questions. The software also has a built in help area that answers many of the frequently asked questions. Our goal is to make sure your deployment continues to be a success!