(ERP) Enterprise Resource Planning

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 facil...

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...

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 ...

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 vari...

Automation/Control Systems Integration

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 j...

Industry-focused Staffing

We offer access to an established network of candidates and provide the resources to fulfill all of your staffing needs.

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IT/Systems Integration

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 who...

Management Service Provider (MSP)

A managed service provider (MSP) provides the delivery and management of network-based IT services, applications, and equipment to enterprises, residences, or other service providers. 

Monitoring Technology

Provides the  inspection system for 100% verification of pharma,medical device,  and Biotech  products in the production process.  Solutions to meet the highest quality standards...

Outsourcing

There are several benefits to this approach:
 • Better potential maximization of cost savings
 • Employment of a select group of providers with consistent, measurable and tracked me...

(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 acc...

Product Sourcing & Strategic Sourcing Solutions

Many aspects like changes, continuing budget scrutiny, increased operating costs, and reduced protection for innovative biological medicines are common concerns amongst pharmaceutical comp...

Process/Cleaning Validation

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 pre...

Program Management

Program Management Consulting Services provides overall direction and support to your programs and related areas such as Program Management Office (PMO).
Lihard Solutions Corp.

Project Management

We understand how project leadership as a core value in your organization can be needle-moving. We help you focus on the key, core PM components so that your organization can increase its maturity substantially and driv...

Quality Systems

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 diffe...

Remediation

We help clients achieve significant and sustainable improvement in their quality performance, customer satisfaction, and regulator...

Serialization

Prior to the enactment of the 2013 Drug Supply Chain Security Act (DSCSA) law,  to there was a  patchwork of State Drug Pedigree and tracing laws in existence. Complying with...

Critical Process Cleaning

Critical process cleaning differs from process cleaning by referring to the equipment and surfaces in the direct manufacturing contact. This means the internal wetted surfaces, not the external shells or housing. Additi...

Validation Services

Our strengths are based on extensive worldwide experience in compliance industries and automation industries. Starting from documentation lifecycles and testing regimes, Lihard Solutions Co...

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 side tracked by growth or change, we can prov...

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