Pharmaceutical IT Industry

Why Regulated Companies need System Validation?

Companies strive to create goals, processes, culture, management, and incentives that build infrastructure. Computer Systems (software) are a dominant and increasing part of business infrastructure. Computer System Validation is process validation and has the following benefits:

  • Excellent Return On Investment (ROI) - Cost of compliance is low with respect to potential loss of intellectual property or other potential losses.
  • Provides documentation required by FDA, other regulatory agencies, and your customers.
  • Maximizes the value of the computer system and the employees that use it.
  • Reduces labor costs by increasing employee efficiency and effectiveness.
  • Enhances project management to ensure projects are implemented on schedule and on budget.
  • Saves money by discovering defects early, before failures occur in production.
  • Reduces risk. Legal liability, not regulatory, is often the most important reason to perform validation. Software is made and used by people so it is guaranteed to be imperfect. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice. Promotes continual process improvement. Software is constantly evolving to keep up with the increasingly complex needs of the people that use it. Therefore, validation is an ongoing necessity.
Validation and 21 CFR Part 11 Compliance Services:

From Project Managers to Validation consultants, InSys provides IT Professionals who have in-depth experience in computer systems validation for the Life Sciences. Our professionals have vast experience in GXPs, 510(k), GAMP, NCCLS, CLIA, Part 11, FDA etc.

User Requirements Specifications:

A document created to define the needs of the user group. Focusing on 'what' objectives need to be achieved. This document is linked to the acceptance criteria of the Performance Qualification activities.

Functional Specifications:

A document created to specify a function that a system component must be capable of performing. Focuses, generally, on 'how' user requirements must be achieved. This document is linked to the acceptance criteria of the Operational Qualification activities.

Master Validation Plans:

A plan created to define validation approach, activities, responsibilities and associated procedures.

Installation Qualification Protocol:

Installation Qualification (IQ) establishes confidence that the system is compliant with appropriate codes and approved design intentions and that manufacturers recommendations are suitably considered. Documented verification that all key aspects of software and/or hardware installation adhere to appropriate procedures and design intentions and that the recommendations of the vendor have been suitably applied.

Operational Qualification Protocol:

Operational Qualification (OQ) is done to ensure that the system is capable of consistently operating within the set limits and tolerances. Documented verification that the equipment-related system or subsystem performs as intended throughout entire operating range.

Performance Qualification Protocol:

Performance Qualification (PQ) establishes, through appropriate performance tests and related documentation, that a system consistently produces a product meeting all pre-determined requirements for functionality and safety. Documented verification that the process and/or total process-related system performs as intended throughout the normally anticipated operating range of use.

Validation Summary Reports:

A concise representation in summary form, of all validation activities conducted within the scope of the protocol or plan. The summary report contains a synopsis of all test results and findings, indicating whether or not objectives were met. Compliance Services: (Internal or Regulatory)

Vendor Audits:

An activity conducted to determine thorough investigation of, and adherence to, established procedures, instructions, specifications, codes and standards or other applicable contractual or other applicable requirements.

Documentation Audits (Gap Analysis):

An activity conducted to determine through investigative measures, the adequacy of, and adherence to, established procedures, instructions, codes, specifications, and standards.

System and Process Audits:

An activity conducted through evaluative measures in order to determine, the efficiency of systems and processes.

Site Audits:

An activity conducted through evaluative measures in order to determine adherence to local SOPs and mandates.

About InSys Technologies

InSys Technologies Inc. helps businesses and institutions meet the complex challenges of the technology revolution. We provide a global source of services across the entire Information Technology (IT) spectrum.

Our founding team have more than 35 years of collective experience in providing IT staffing services, Quality Software Solutions, Professional Services, BPO and RPO services to various customers who range from small to big businesses.

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