Independent Validation Services
StayinFront has teamed with Interphase Systems Inc., a leading technology and business consulting organization specializing in data validation and compliance services.
As part of Interphase Systems’ strategic business consulting services, the company provides organizations with audit preparation, remediation and compliance services through a dedicated validation and compliance practice that is specifically focused on the many validation areas for Pharmaceutical companies including SFA/CRM, Infrastructure, LIMS, ERP and Sample Management. Interphase Systems’ validation solution will assess the IT infrastructure of StayinFront life sciences customers to ensure that their networks are in compliance with the regulations of the Prescription Drug Marketing Act (PDMA). Interphase Systems’ prepackaged solution provides organizations with a cost effective compliance framework to speed the delivery of system validation.
“Our two organizations have invested in harmonizing our data management, quality assurance and reporting solutions, resulting in reliable, accurate, and independent validation and compliance processes” says John Biglin, CEO Interphase Systems, Inc.
| The key to the Interphase offering is their Enterprise Validation Framework that enables Interphase to follow a standard methodology for conducting a validation certification. By using the same framework in a number of different areas inside a company, it enables customers to have a common, repeatable and sustainable validation process and provides documentation and reports that auditors can be comfortable with and learn to expect. | ) (click to enlarge) | |
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| The unique aspect that Interphase brings to the StayinFront relationship is that of a truly independent organization. Interphase independently represents the customer, not other systems vendors or partners. Other companies offering validation and compliance auditing services are often owned by organizations that present a conflict of interest. The relationship between StayinFront and Interphase is that of two independent solution providers with solid industry experience providing specialized services for their clients’ primary compliance and validation objectives. Interphase is meticulous and efficient in their approach to ensuring a customer’s validation needs and compliance requirements are met and properly maintained. | ||
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| By having a strong partnership with StayinFront, Interphase gains the ability to look inside a customers "software release" before it is implemented into the customer’s environment for testing. This enables the validation team to prepare for the validation ahead of time. | |
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Interphase Systems has developed a unique best practices process and set of procedures for every aspect of a customer’s requirement needs. Examples of key process elements include:
- Risk Assessment
- Project Validation Plan(PVP)
- User Requirement Specification (URS)
- Functional Requirement Specification (FRS)
- System Design Specification (SDS)
- Installation Qualification (IQ)
- Performance Qualification (PQ)
- Validation Summary Report (VSR)
- System Release Certificate
StayinFront in conjunction with Interphase Systems evaluates all elements of regulatory requirements and provides recommendations and solutions to assist customers in meeting such requirements. StayinFront and Interphase Systems provide solutions in adherence of policies and procedures from multiple sources such as the Prescription Drug Marketing Act (PDMA), the Controlled Substances Act (CSA) as well as other state and federal compliance mandates such as FDA's 21 CFR Part 11 for Electronic Records and Electronic Signatures, FDA 21 CFR Part 205, relating to the distribution of prescription drugs, Drug Enforcement Administration (DEA) policies and Standard Operating Procedures (SOP) systems such as ARCOS, Automation of Reports and Consolidated Orders System and GERM Good Electronic Records Management. StayinFront and Interphase Systems follow industry standards of regulatory guidelines to ensure your infrastructure is properly validated and compliant:
- 21 CFR Part 11 (Electronic Records and Signatures)
- GAMP (Good Automated Manufacturing Practice
- GERM (Good Electronic Records Management)
- GDP (Good Documentation Practice)
- GTP (Good Testing Practice)
- GLP (Good Laboratory Practice)
- GMP (Good Manufacturing Practice)
- GCP (Good Clinical Practice)
StayinFront and Interphase - The Big Picture
As experts and thought leaders in the industry, StayinFront and Interphase Systems provide clients with a level of confidence required in the complex and often labor intensive field of regulatory compliance and validation. Our strict adherence to federal and state guidelines and our innovative technology solutions reduce the regulatory challenges and risks companies face. StayinFront and Interphase provide an easier, more predictable and less expensive way to manage regulatory validation requirements.
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