Regulatory Compliance Associates Inc. computer validation experts and software engineers are well versed with the GAMP validation model, and have the experience to ensure your project has the appropriate level of documentation. Our extensively trained and experienced staff plan, author, and execute hardware, software and network qualification protocols, and prepare summary documentation. We ensure user requirements and functional/design requirements are properly tested and documented. Regulatory Compliance Associates Inc. also prepares SOPs and performs training for those responsible for operating and maintaining computer systems and computerized equipment.
Our computer validation experts provide the following validation services:
21 CFR Part 11 Electronic Records; Electronic Signatures
Regulatory Compliance Associates Inc. provides complete Part 11 validation services, from initial gap analysis, through final summary report generation, SOP writing and training. Services include:
- Assisting with Corporate Policy Development
- Gap Analysis
- Solution Identification and Strategy addressing:
- Passwording
- Audit Trails
- Electronic Signatures
- Archival and Retrieval of Documents and Data
- Legacy Applications and Systems
- Remediation Planning
- Project Management and Implementation
- Vendor Audits and Evaluation
- Qualification
- Life-cycle
Laboratory Systems Validation
Lab equipment, workstations, and networks, which transmit, collect, archive, and retrieve GMP data are required to be qualified and maintained in a validated state. Regulatory Compliance Associates Inc. provides support in determining which of our client’s lab systems needs to be qualified, and provides validation services to ensure these systems meet regulatory requirements. Regulatory Compliance Associates Inc. recommends the GAMP validation model and format, or the uses the client’s preferred format. Our lab system validation experts have the experience to provide validation services for new or legacy systems, and to create new life-cycle programs to maintain our client’s lab systems in a validated state, or integrate these systems into your existing life-cycle validation programs.
Network Infrastructure Validation
The key to a successful, cost-effective network validation is proper validation boundary identification. Improper boundary identification may result in noncompliance and/or huge life-cycle costs. Unlike many validated systems, most networks are dynamic, that is, they are in a constant state of flux or change. Improper boundary identification and qualification will result in unnecessary restricted network function, and/or users not adhering to SOPs, in order to perform their work in a timely manner.
Regulatory Compliance Associates Inc. computer validation experts have the experience to identify sensible network validation boundaries, which will allow the network to meet regulatory requirements and your company’s functional requirements at the same time. Our experts determine and implement the proper level of documentation and control, to allow our client to efficiently and effectively maintain your network, or a portion of their network, in a validated state.
Automation and Control Systems
Designing and maintaining automation and control systems in a manner that is consistent with cGMPs, and is cost effective at the same time, can be challenging for any company. Regulatory Compliance Associates Inc. offers clear, technical compliance solutions, which meet regulatory requirements and improve system function.
- Controls Master Plan Development
- Project Process
- Design Strategies, Including Boundary Identification
- System Qualification
- Management of Change and CAPA Strategies
- Periodic Review