Data Integrity
Data integrity is more complex than just knowing where your data is stored and who has access. The FDA’s 2018 guidance “Data Integrity and Compliance with CGMP Guidance for Industry” clarifies the role of data integrity in the regulated space. The FDA expects all data, whether electronic or on paper, to be attributable, legible, contemporaneous, original and accurate (ALCOA). The guidance recommends implementing meaningful and effective strategies to manage data integrity risks based upon process understanding, management of technologies, and business models.
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But what does this guidance mean for your business and your lab? CSols tailors our data integrity engagements to meet the needs of individual clients.
True data integrity means being able to answer:
- Where is my data?
- How does my data move through my local systems?
- How does my data move through my enterprise systems?
- Who has access to my data?
- Does my data adhere to ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)?
- Is my data protected?
- Is all my data readily retrievable?
Planning
If you are not sure where to begin, who to trust, or where to find the highest value, contact CSols today to learn how to plan for all your laboratory informatics needs successfully. From high-level strategic planning and validation planning design to detailed data management and program management plans, CSols has the experience and expertise to help you plan for success.
OUR PLANNING SERVICES
- Laboratory Informatics Planning
- Laboratory & Scientific Data Management Strategy
- Program Planning & Management
- Validation Strategic Planning
Implementation
Laboratory Informatics System Implementation
Your business depends on your lab data so your systems must reliably process, store, analyze, and report laboratory data. LIMS, ELN, LES, and CDS are the best tools to manage this data, but even the best tools need to be applied correctly. CSols helps quality control, R&D, and analytical services laboratories of all sizes upgrade existing systems and implement new. Implementing or upgrading complex laboratory informatics solutions requires specialized experience and expertise—hiring a general IT consultant can put your project at risk. CSols specializes in laboratory informatics: we’ve created a proprietary implementation methodology to lower risks for our clients and ensure maximum user adoption and maximum system value for all types of laboratory systems implementations and upgrades.
Validation
The FDA, Health Canada, MHRA, EMA, and other regulatory bodies require regulated companies to perform computer systems validation (CSV) on any software system used to collect, store, analyze, report or transfer data in the place of paper data in cGMP, cGLP, and cGCP environments.
CSols’ validation experts understand the science, infrastructure, and instrumentation as well as the regulatory agency audit processes and tailor validation services to each client to reduce validation risk.
Clients tell us that their laboratory informatics systems, instrument systems, and computing environments were compliant and defensible more quickly and with fewer resources when compared to their experiences with generic CSV consultants.
Our multi-disciplinary CSV consultants speak the language of your business, your IT department, and your laboratory informatics systems and instruments.
This in-depth understanding reduces knowledge transfer time and gets your project started rapidly: we can quickly understand your regulatory needs, laboratory informatics and instrument systems, business and laboratory processes, information and data workflows, and how your computer systems bring all those activities together.
Our understanding of real-world regulatory agency practices allows us to effectively and efficiently help you plan, implement, and verify a fully compliant, defendable system in any computing environment.
CSols delivers CSV services using the GAMP®5 risk-based approach. We can assist you during any project stage, from concept to planning and executing, through operation and upgrades, and even system retirement.
CSols specialized knowledge and expertise can support your validation project.
Address
1102 E 16th Street, Indianapolis,
IN. 46202
info@micgamag.com
Phone
3179180955