WELCOME TO SEBALD CONSULTING
Headquartered in sunny San Diego, California, Sebald Consulting is dedicated to providing customized engineering support to life science companies as well as other regulated industries. We can contribute to projects of any size, from getting equipment up and running, getting through a compliance issue, or managing large projects, we are here to help where we can.
We have real-world industry experience designing and implementing systems and participating in FDA audits. Our experience includes electrical and process engineering, project management, and development of calibration, engineering, maintenance and manufacturing departments. We also support computer system validation CSV and equipment qualification from conception through the full validation life cycle.
Automated system experience includes Allen Bradley, Siemens APOGEE, DeltaV, Johnson Metasys, Distech, WonderWare and others.
Equipment systems include HVAC, SCADA systems, fermentors, autoclaves, fillers, depyrogenation ovens, manufacturing and packaging equipment trains, and others.
Computer system validation includes control systems, computerized systems, EDMS, SCADA, BMS, CMMS, medical device, and other systems.
With our partners, we can deliver qualified systems with documentation in multiple languages, systems which operate in multiple languages, or qualify systems which have been delivered with documentation in multiple languages.
We would love an opportunity to work as part of your team, within your company culture, to help you achieve your goals.
Automation
Experience With Automation Systems
We can help you maintain compliance with cGMP requirements by putting over two decades of control system design experience to work for your including:
- Developing systems for custom applications
- Quality work that will meet your requirements
- Providing development guidelines
- Assisting in organization/development of documentation
- Helping with change control of establishment systems
- Providing SMEs for control system and automation projects
- Auditing Providers
- GAMP 5 and 21CFR11 gap analysis
- ISA S-88 Batch system development
- Validation of automated systems
- Developing and or validation of database systems
Computer System Validation
Start to Finish Computer System Validation (CSV)
We can help you get a computer system validated quickly and efficiently. We are familiar with requirements for computerized systems to meet FDA and EMEA requirements including:
- Medical Devices
- Building Management Systems (BMS)
- Electronic Document Management Systems (EDMS)
- Process Control Systems
- Equipment Control Systems
- Data Acquisition Systems (SCADA)
- Calibration and Maintenance Management Systems (CMMS)
- Asset Management Systems
- Custom-coded, Configured, Off-the-shelf, of SaaS based systems
Software Systems
Experienced in Software Development and Validation
We can help you maintain your software compliance with cGMP requirements by putting experience designing and qualifying software that you need:
- Developing control systems and databases for custom applications
- Prospective and retrospective validation
- Providing development guidelines
- Helping you to get more life out of an old system
- Auditing Providers using traditional and agile development models
- GAMP5 and 21CFR11 gap analysis
Project Support
We Work With Your Team
Whether leading a team on a project or acting as contributors, we can help you get the job done on schedule and within budget.
This includes:
Remediation to address 483/warning letters; construction or automation projects; root cause analysis; audits or gap analyses; and automation (21CFR11, GAMP) of other support services (calibration, maintenance, etc.).
We can put together documentation to support projects including system requirements, specifications, technical drawings, qualification plans and protocols, reports, SOPs, etc.
Root Cause Analysis (RCA)
Tried and True Methods to Find Out What Went Wrong
We have many methods at our disposal to help you find the root cause of issues and we can provide an independent facilitator to work with your group to find and fix the problem. Often, this can reduce the amount of work your company is doing related to a problem.
Gap Analysis/Training
Identify and Remediate Gaps: Customized Training to Meet Your Needs
We can help you identify gaps in your compliance before your customers or regulatory agencies do and that can improve your rate of compliance.
Implementation of cGMP systems is highly dependent on early training, planning and configuration. Simplify your work and reduce your exposure with good training.
We can provide training to automation and software developers to help them comply with new requirements generated by cGMPs, 21CFRPt11, GAMP 5, and other sources commonly reference by your potentials customers.
If you are an end user, we can help you achieve documented compliances with FDA and EU requirements.
Legacy Systems Support
Experience Bringing Legacy Systems Into cGMP Compliance
We have experience with qualifying systems that may not have been initially designed for qualification. Perhaps some equipment that was carried over from R&D, or a control system which is outdated, or an HVAC system that is already in place.
Based on an initial review of the existing systems, we can help you determine what upgrades may be required and provide you with ongoing system support if appropriate. This may result in a solution that will work for your situation.
We have experience with the bringing legacy systems into cGMP compliance:
- Retrospective validation
- Identifying cGMP gaps
- Review systems for 21CFR11 Compliance
- Upgrading systems where necessary
- Generate testing and documentation to demonstrate GMP compliance
We can put together documentation to support projects including system requirements, specifications, technical drawings, qualification plans and protocols, reports, SOPs, etc.
We can develop automation systems, help integrate systems, or support your system after delivery.
Equipment Rental
Filling that equipment gap
Sometimes you just need a piece of equipment quickly to get through a project. We offer a limited list of equipment that is commonly used in industry to help you get bridge that gap. There could be many reasons you may find yourself in a situation needing short term equipment:
- Equipment you don’t need often, so you may not keep it in stock and/or calibrated.
- Your equipment may be out for calibration or maintenance.
- The calibration interval for your equipment may have expired.
- Your equipment may be out for repair.
Regardless of the reason, we can provide your trained personnel with equipment/instrumentation, on an as-available basis, to bridge the gap and keep you on schedule, and the calibration documents to back it up.
We provide commonly used calibrated instruments on a rental basis for short or long term use. If you need a calibrated instrument on short notice, check our inventory and we may have it. Our no-hassle policy allows you to get your hands on calibrated equipment on short notice for those emergency projects. Contact us if you don’t see it listed. We may have it in stock!
Human Centered Design
Great Design Improves Safety, Efficacy, and Acceptance
Optimize system design to make it intuitive to use and interpret, robust enough for the intended use environment, and suited to the task. Reduce error rates, improve performance and perception. Our staff specializes in cutting edge Human Centered Design Engineering including the following: Human/Machine Interaction, Intuitive Design, Perception and Performance.”
Technology Partners
We are proud to promote and use as resources many of the companies we have worked with on projects over extended periods and found to provide some the best services available.
We have strong working relationships with these businesses and can bring their expertise to bear, as well as our own, on various projects.
Universal Dialog – Provides an array of translation, interpreting and localization services. They specialize in technical translations and can handle over 50 languages. From 2 to 20,000 pages, they can handle it, on time, on budget.
BBCS – BB Consulting Services provides customized validation and cGMP support services with a strong project management style so there are no surprises. On time, on budget.
GxPReady! – GxPReady! provides 5-star rated GxPReady! Suite, an on-line validated calibration, maintenance, and validation management software for life science companies and others regulated by the FDA or EMEA. They can get you up and running quickly with a validated system at a reasonable cost while meeting applicable regulatory requirements including GMPs, Title 21 CFR Part 11, EU Annex 11 and others.