Information Technology Consulting
Your business never stops; it constantly evolves, and so must your must your compliance efforts when it effects the technology which supports it. Here at ATC we’ve invested our leadership, people, and support technologies, and never stop working to ensure your success. The result: validation approaches that are cost effective, transparent, and capable of effectively managing compliance risk.
Information Technology Assessment
Technology solutions are by their nature, often large-scale and complex. Applying 21 CFR Part 11 requirements consistently from department to department and site-to-site begins with an accurate assessment. ATC listens to our clients and develops solutions that are tailored to their unique challenges.
ATC Corporation of Indianapolis Provides:
- Applicability of traditional validation approaches to modern system implementation strategies based on rapid prototyping and rapid re-configuration
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Elimination of unnecessary redundant efforts across concurrent implementations
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Consistency of interpretation of predicate rule and 21 CFR Part 11 requirements across sites and geographies
There are two main areas of emphasis for our compliance and validation solutions.
Validation and 21 CFR Part 11 Risk Assessments
Many companies want an independent assessment of their validation and 21 CFR Part 11 compliance efforts for the following reasons:
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Identify organizational structure for addressing validation and Part 11 compliance
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Assess the effectiveness of validation and 21 CFR Part 11
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Identify opportunities to more efficiently embed validation into the systems development life-cycle to realize cost savings
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Understand where the company stands as compared to industry peers
ATC Corporation of Indianapolis delivers:
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A specific, customized technology implementation project
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A plan for your organization’s computer systems validation approach
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A package outling your organization’s 21 CFR Part 11 Program
Validation and 21 CFR Part 11 Program Management
Our Program Management solutions focus on the 21 CFR Part 11 programs.
ATC Corporation of Indianapolis delivers:
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Assessment of the effectiveness of validation and 21 CFR Part 11 for pre-existing systems
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A customized program with defined structure including roles and responsibilities
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Establish interpretation or methodology for the project
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Integrated validation activities and deliverables into the project's system development life-cycle
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Establishment of lean processes, checklists, templates, work instructions and training materials to leverage project team activities in the achievement of validation objectives
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Establishment of inventory, assessment, prioritization, remediation planning and remediation planning templates and processes for 21 CFR Part 11 compliance
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Listing of managed activities of internal and external resources to efficiently and effectively address validation and 21 CFR Part 11 activities
Information Technology Validation
Computer validation requires a cross-functional skill set that encompasses IT expertise, working QA knowledge (including GXP practices and computer validation), business acumen, and software modeling. The members of the team should understand GAMP and software development life-cycle methodology. The team must fulfill many tasks during the project, each requiring a bit of specialization.
ATC Corporation of Indianapolis delivers based on four main themes outlined below:
Compliance Risk Management
Global technology solutions offer new ways to manage compliance risks that may impact the quality, safety and efficacy of a product. The FDA's risk based emphasis has been increasing as outlined in GMP’s for the 21st century, the ISPE/GAMP white paper and the new 21 CFR Part 11draft guidance. A practical way of thinking about risk, from a compliance point of view, is key to managing risk consistently across the enterprise.
Cost Containment
Our experience has shown that lean processes that foster a collaborative approach between validation and quality assurance project teams is the most effective way to improve team morale and manage the cost of validation. This process also promotes a first pass quality approach that builds quality into documentation as opposed to providing feedback after the fact and that often requires significant rework.
Standardization
A common methodology is needed to effectively manage the costs associated with address validation. Many companies do not have a standard methodology with templates and tools to efficiently and effectively complete validation deliverables. If these templates and standards are not in place and understood by all project team members before they are needed on the project, documentation will not be consistent and may require significant rework.
Roles and Responsibilities
It is critical to ensure that appropriately skilled validation and quality assurance personnel are involved from the beginning of a project with the appropriate knowledge and skill sets to identify compliance risks and to work with project teams to develop practical solutions to manage these risks. The traditional role of validation and Quality Assurance is challenged on large-scale global implementation efforts. Defining roles between corporate and site resources is also critical. Additionally, consistent communication between sites from the beginning of a project is essential.
Validation Programs
Once the process is understood and the project roles have been assigned, the task of developing and executing the validation program begins. It is important to remember that the automation of systems, once operated manually, can have profound consequences on product quality in the event of system failure. It follows that the validation of automated systems has and will continue to assume great importance in the validation of a production facility and in the eyes of the FDA and other regulatory agencies.
ATC Corporation of Indianapolis offers hands-on prospective validation of systems from the conceptual design phase and in concurrent and retrospective validation of existing systems. ATC’s personnel have a depth of experience in computer and computerized systems at all levels, including business and management systems, networked manufacturing control systems and local production level control monitoring by PLC’s and PC’s.
ATC Corporation of Indianapolis provides assistance with the following activities:
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Definition of Requirements
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Writing of Functional Specifications
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Preparation of Validation Approach Philosophy
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Documentation Analysis of Documentation and Testing Requirements Interpretation of Standards and Regulatory Requirements
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Vendor Audits FAT and SAT Witnessing and Approval
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Software/Hardware Validation Good Automated Manufacturing Practices [GAMP] Systems Integrity Consulting
Electronic Records and Electronic Signatures
21 CFR part 11 specifies the technical and organizational controls that must be in place in order to use electronic data and documents in lieu of paper records for the documentation of GxP processes.
The ability to effectively manage complex documentation while meeting regulatory compliance and product approval timelines results in millions of dollars in lost revenue for companies each year. Don’t make it yours.
ATC Corporation of Indianapolis delivers systems which:
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Keep the company in line with the FDA’s requirements (CFR 21 part 11)
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Manage your company’s SOPs more efficiently (GLP, GMP and GCP)
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Build IND and CTA submissions
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Compress IND and NDA submission time
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Are simple, affordable, scalable and compatible
Additionally, the ATC Regulatory Compliance Team Delivers:
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Audit Trail Evaluations
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Workflow Diagrams
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Security System Evaluations
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Complete IQ, OQ, PQ Packages for all Electronic Data Evaluations
Let us appoint one of our validation engineers to the head up your task needs today!
