With our extensive experience in laboratory data and information management, Novatek’s professional services team understands your business and provides the services that you need to optimize your processes. From validation to training, we offer the support you need and we ensure that your project is completed on time and within budget.

Novatek’s service and support is unparalleled in the industry. We provide the support that you need every step of the way, with technical assistance centers (TAC) that are available 24/7 and offices throughout the world.

Validation:

As healthcare manufacturers such as pharmaceuticals, biotech’s, API manufacturers, drug delivery manufacturers, nutritional products, contract manufacturers and medical device companies need to comply with cGMP, GALP, GAMP and 21 CFR Part 11, providing validation services is key to a successful implementation of an automated data acquisition and management system.

The Software Validation Package provided contains:

• User Requirements Specifications,
• Design and Functional Requirements Specifications,
• Validation Matrix,
• Validation Test Plan,
• IQ/OQ validation document,
• User Guide and
• Installation Guide.

Novatek’s validation specialists work with the customer’s validation team to perform gap analysis, and execute the IQ/OQ validation onsite in order to ensure the system’s proper functioning and to complete the necessary documentation to help satisfy the regulatory and compliance requirements.

Continuous improvements to our laboratory information and data management software products have been and continue to be of an incremental and evolutionary nature, and are incorporated with rigorous attention to documentation and protocol. The software's underlying structure and foundation have effectively endured the 'test of time' with multiple systems installed in several countries around the globe.

Consulting:

Novatek offers an array of consulting services to complement our existing and growing suite of out-of-the-box, process-based quality software solutions. These services are meant to enhance and streamline your processes within the quality, R&D departments and pharmaceutical manufacturing.

We will be servicing the following industry sectors that require FDA CFR 21 Part 11 compliant systems for cGLP/cGMP:

• Pharmaceutical
• Biotechnology
• Food
• Military
• Government
• Hospital
• Educational
• Medical Device
• Tissue/Blood bank
• Chemical
• Veterinary
• Nutraceutical

Novatek’s knowledgeable consultants offer a full range of services at our headquarters in Montreal (Canada), at our international offices, and onsite at our clients’ facilities globally:

We provide the following:

(1) Technical Writing for: SOPs, validation reports, industry portals, websites and databases.
(2) Training Courses for: cGLP/cGMP, environmental monitoring, stability testing, process validation, and microbiology techniques.

Integration:

Novatek integrates with various laboratory and manufacturing instruments such as, air samplers, HPLCs, particle counters and analytical balances.

We’ve also successfully integrated with third-party software such as SAP, Oracle, other LIMS systems and manufacturing plant monitoring systems.

Training/Seminars:

On a semi annual basis Novatek conducts seminars on various topics of interest within the industry.

Novatek’s objective is to provide an environment in which experts in specific fields can interact and share their knowledge. Novatek’s intent is to provide pertinent and industry-specific information focusing on the areas of Environmental Monitoring, Stability and Regulatory compliance, and to encourage lively discussions consequently broadening the knowledge of the group as a whole.

Since only a limited number of sponsors are invited to these seminars, there is a great opportunity to market your product directly to the decision makers in a friendly relaxed environment. Please refer back here for updates on future events.

LIMS | Laboratory Data | Information Management Services.