experience

Trusted Consulting ∙ Innovative Solutions ∙ Quantifiable Results ∙ Superb Service

Our diverse experience, which includes coaching, mentoring and team building in GxP environment, has enabled our clients to successfully addresses regulatory challenges an operate in a more streamline manner.

. We have successfully provided the following services:

Operational Expertise
Computer Systems
Pre-Approval Inspection
Pharmaceutical and Manufacturing
Consent Decree

Enterprise Resource Management

Our strength is the ability to digest thousands of pages of federal regulations and understand the impact on daily operations in pharmaceutical, healthcare and manufacturing industries. Specifically, we:

Implement new technologies in regulated environments to incorporate the client’s quality management system while adhering to established federal regulations
Develop & implement standards, processes, procedures, policies and guidelines to ensure regulatory compliance
Perform validity testing for affected software systems, processes and procedures

The following tasks were performed as part of the implementation team for several clients including:

Stryker and Astellas -Implemented a Global SAP HANA S4 ERP system and SAP Solution Manager to standardize manufacturing resulting in improved efficiency and quality while reducing cost.
Stryker -Implemented HP ALM Connect and Version One creating an electronic means of documenting test results that allows for globalization
GE Healthcare -Upgraded Oracle e Business suite ERP system Schering Plough -Validated a PRISM AS400
Schering Plough -Validated Fourth Shift ERP

infrastructure

Clients call on our Subject Matter Experts (SME) to answer the “how” when facing challenges such as:

Deciding when to Qualify versus Validate Data Centers
How to successfully migrate legacy Data Centers to a Software Defined Data Center (SDDC) while maintaining a validated state and without disruption to daily operations
How to protect your intellectual property from cyber-attack, internal threats, intrusion threats, spying or hackers
How to reduce man hours and reduce the cycle time to qualify/validate Data Centers
SMEs are available to mentor, coach, and advise IT professionals by developing methodologies and strategies to respond to these challenges

Examples of tasks include:

Johnson and Johnson- Validated and Qualified a SDDC reducing their carbon footprint by more than half; needed manpower by 60%; and cycle time to qualify infrastructure components by 1500% resulting in a cost savings of $3.9B over 10 years
Johnson and Johnson, Astellas, Stryker, GE Healthcare, McNeil Nutritionals - Created the documentation, protocols and Standard Operating Procedures
Johnson and Johnson - Qualified workload migration process from legacy Data Center to a SDDC by creating a proprietary process for validation statistical testing
Johnson and Johnson – Qualified a Network Monitoring framework that monitors 30,000 infrastructure components allowing for global patches and upgrades; Worked with internal Quality team to define the scope of the rigor needed to ensure least impact on data security and integrity; Created documentation based on GxP and computer system validation; Validated Migration tools such as Double take and AppZero for use in workload migration
Johnson and Johnson- Validated database migrations for SQL and Oracle Workloads using automated and manual scripts for 3000 Database workloads
Novo Nordisk- Qualified a SharePoint implementation infrastructure as IaaS

consent decree

SMEs bring 20+ years of experience in validating computer systems, leading remediation teams and providing third party oversight in the pharmaceutical and manufacturing environments. Several clients avoided the need for an FDA approved third party vendor based on the knowledge and expertise our staff brought to the team.

Examples of tasks performed include:

Schering Plough -Remediation leader for Puerto Rico manufacturing sites. FDA determined that remediation could move forward without third party over-site based on team’s Computer System Validation expertise
Scope – 5-year period; 3 major plant facilities with 300+ computerized systems; met every significant step for computer system validation without delays or additional penalties, coaching, mentoring, project management, and FDA inspections support
GE HealthCare -Validation leader for Oracle e Business suite ERP system remediation while under consent decree; First time an Oracle application was validated for this company, and the first time a content management system for the new GE Healthcare customer portal was validated
McNeil/ McNeil Nutritionals —Member of third party as Automation Lead

operational

Experience

Medical Device (software, implants); Liquids Manufacturing; Solid Dosage; Biotech

Pre-approval

inspection

Remicade; Claritin; Zetia

Computer Systems

expertise

ERP (SAP/Oracle); Adverse (SaaS); Track and Trace; Glatts; Packaging Line; PLC (Implemented in a Distributed Control scheme); Laboratory Systems