Enterprise Resource Planning (ERP) is an industry term for the broad set of activities that helps an organization manage its business. An important goal of ERP is to facilitate the flow of information so business decisions can be data driven. ERP software suites are built to collect and organize data from various levels of an organization to provide management with insight into key performance indicators (KPIs) in real time.
ERP software suites are built to collect and organize data from various levels of an organization to provide management with insight into key performance indicators (KPIs) in real time.
Regulatory / Compliance Strategies
We take the approach that the essence of successful drug development is the management of risk and the removal of uncertainties. Lihard Solutions Corp.’s experienced consultants understand the value of your new product pipeline and work with you to develop and/or execute regulatory strategies that optimize the likelihood of approval, minimize costs, and increase efficiency.
Computer System Validation
Computer System Validation (CSV) provides documented proof that the system (e.g. hardware, software, peripherals and network) will repeatedly and reliably do what it is designed to do, is “fit-for-purpose”, and complies with the applicable rules and regulations.
Risk, regulatory, and compliance requirements are driving significant costs for financial institutions in today’s market. It is our view that, if approached strategically, the compliance, risk, and regulatory functions can evolve from their traditional value-add activities to help drive strategic business priorities.
Facilities-Utilities Equipment Qualification
All pharmaceutical manufacturing facilities need to adhere strictly to FDA-approved regulations. The importance on the compliance of facility design with cGMP regulations as well as the various procedures associated with pharmaceutical production, so drugs are manufactured under conditions that meet FDA approval.
Failure to meet FDA regulations can result in responsive action by the authorities against the product or the responsible facility, depending upon the seriousness of non-compliance. The company may have to recall the product under orders of the FDA, to ensure it does not cause additional harm or risk to the public.
CGMP requirements can be useful in ensuring the efficacy, quality and safety of pharmaceutical products by making sure facilities are in good operating condition, with sufficiently calibrated and well-maintained equipment, trained and experienced staff and reliable and efficient processes.
While a utility system cannot affect product quality on its own, it forms an integral part of the manufacturing process using and meeting expectations of regulated manufacturers to satisfy requirements for design, installation, operation, and performance of controlled processes to assure that they can consistently produce product meeting defined quality requirements.
Process control systems integration has generated much discussion over the years. Even though plant managers know that integration improves efficiency over time, they often have difficulty justifying the initial project cost. Lihard Solutions Corp. can help by developing a logical industrial automation integration solution for your plant that will deliver substantial ROI.
In information technology, systems integration is the process of linking together different computing systems and software applications physically or functionally, to act as a coordinated whole.
Imagine making an extremely important business decision hinging on data that is entirely, or even partially, inaccurate. Organizations routinely make data-driven business decisions, and data without integrity, those decisions can have a dramatic effect on the company’s bottom line goals.
With a team of highly experienced experts from different backgrounds and proven worldwide experience in the Data Governance System, we aim to ensure the integrity of regulated data relies upon the validation of the computer system responsible for managing regulated data.
This results in the assurance of the systems validation life cycle, which in turn enhances and improves product quality, patient safety and data integrity.
(OEE) Overall Equipment Efficiency
Overall Equipment Effectiveness. OEE takes into account the various sub-components of the manufacturing process – Availability, Performance and Quality. After the various factors are taken into account the result is expressed as a percentage.
Cleaning Validation FDA expectations are a documented series of activities that provide a higher level of assurance that the cleaning conducted on manufacturing equipment was done to a predetermined, justifiable, rational and reasonable level of cleanliness. This must be conducted via pre-approved protocols and execution done with enough consecutive replicates to demonstrate process control.
The QS regulation embraces the same “umbrella” approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.
Quality-by-Design (QbD) and Process Analytical Technology (PAT) to achieve Real-Time Release testing (RTRt). Our group has the operational leaders who obtained the first worldwide FDA approval on Real-Time Release testing for a control release product developed under QbD.
- PAT / QbD / RTRt / CPV
- Process Development / Cleaning / Validation
- Technology Transfer and Validation
- Method Transfer and Validation
Our strengths are based on extensive worldwide experience in compliance industries and automation industries. Starting from documentation lifecycles and testing regimes, Lihard Solutions Corp. has experience with international validation standards such as those of the MHRA and EMA, in addition to our own FDA requirements.
Validation services are often an integral part of a complete turnkey package supply; however, we also supply the service stand-alone either as a prospective or retrospective validation project. Retrospective validation requires a very specific skill set blending system technical knowledge with process/operation knowledge and of course validation skills. We have the personnel that enables us to offer this rare blend of skills.
Quality Compliance Services
Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance. To help you avoid getting sidetracked by growth or change, we can provide third party audits to identify compliance issues before the FDA or a customer does. Our experts help ensure that you’re meeting the requirements of your quality system or see how far you need to go to meet it.