Why You Need Computer 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, InnoPTe possesses in-depth experience in computer systems used in the Life Sciences. Quality Assurance needs are effectively achieved by combining technology expertise (SDLC) with regulatory knowledge; GXP’s, 510(k), GAMP, NCCLS, CLIA, Part 11, FDA etc.
InnoPTe’s independent Consulting Services group has extensive experience in providing Validation and 21 CFR Part 11 Compliance services following GAMP 4 methodology that includes the following
Computer-Related Systems |
|
Spreadsheet Validation |
|
Enterprise Systems (ERP, MRP-II) |
|
Plant Floor Systems (MES, SCADA, DCS) |
|
Laboratory Systems (LIMS, Stability) |
|
Electronic Document Management Systems (EDMS) |
|
Computerized Maintenance Management Systems (CMMS) |
|
Database Management (Environmental Monitoring, Trending) |
|
Validation and Technical Services |
|
Validation Planning (Validation Plans and Procedures) |
|
Preparation of Functional and Design Specifications |
|
IQ, OQ and PQ Protocol Preparation and Execution |
|
21 CFR Part 11 Assessments and Remediation |
|
Data Migration and System Configuration
Validation Package- Methodology
InnopTe use following methodology to accelerate system implementation and reduce costs. |
IMPORTANT CONCEPTS:
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 manufacturer’s 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.
|
| ? |
|
|
???
Compliance & Validation Services