21 CFR Part 11, FDA's requirements for the use of electronic records and electronic signatures, continues to be a challenging compliance issue for regulated industry. Applitech can help you understand and implement a risk-based approach rooted in FDA's Final Guidance for Scope and Application. From initial gap-analyses and remediation planning for existing systems, to prospective assessments of new systems, our experience will help you determine the Part 11 relevance and associate requirements for compliance.
We can provide proven, experienced validation project managers that have the training and expertise to get your project done on time, within budget, without sacrificing quality.
When you need a validation master plan to help you get it all together, or if you think your current validation master plan may need some improvements, we have the people you can rely on to get a quality job done. Our validation experts have prepared validation master plans for many of our clients, and are familiar with the ever-changing regulatory environment.
If you need quality CGMP training, or have an upcoming audit, we can help. Our expert trainers have the skills necessary to teach your employees basic and advanced CGMP concepts that are applicable to your product and processes in a short course. Employees will learn the important elements of current GMP's, and will learn how to interact with regulatory authorities. For employees with previous CGMP training, we offer refresher courses that cover recent changes in the regulatory climate that affect your company.
As CGMP requirements change and regulatory expectations of manufacturing requirements increase, it is difficult to know if your facility is keeping up. Applitech can offer experienced auditors, which have been through FDA, MCA, and other audits; to give you a head's up on what might be issues with your facility. Our auditors are trained not only to be able to find potential problems, but also to suggest the most cost-effective ways of resolving the problems. Our auditors keep a finger on the pulse of the regulatory environment so you don't have to.
Our validation consultants are skilled protocol preparation experts. We work within your documentation system, using your templates and formats if you have them, or we will custom tailor a format to fit your needs. We are familiar with all aspects of equipment and computer validation. We are skilled at producing quality documentation on time and within budget.
We have the trained validation staff to help you execute validation protocols. Our validation engineers are skilled in computer validation, equipment qualification, SIP and CIP, and are skilled problem solvers, familiar with the problems that can occur during execution and the techniques that can be used to ensure that a project is completed on schedule and with a high attention to quality detail.
Often one of the most difficult aspects of validation projects is the report writing. In a time when turnover of validation personnel is high, often execution is finished by one employee, and the report doesn't get written before they leave. Our engineers are able to pull the data together and get quality reports out quickly, even if someone else performed the work.
Our engineers have the experience to tie all aspects of start-up of a new facility together. Applitech has a proprietary software system, which collects and manages engineering information throughout the design and construction effort. This information is used to automatically generate the validation protocols with the most up to date information pre-printed in the document from the database. Our technical experience can help you in all aspects of facility development, from cleaning agent selection to SIP system design.
An important aspect of cGMP requirements for validation is the necessity of periodic revalidation. Applitech can set up and operate a revalidation program to maintain a constant state of validation compliance on all of your essential equipment.
As technology and automated systems are rapidly advancing in the pharmaceutical, biotech and medical device industries, our computer validation engineers can work independently or within your computer validation department to ensure that all of your computer systems meet regulatory requirements.
Applitech offers validation of following computer/automation/instrumentation systems:
- Programmable Logic Controllers (PLCs)
- Supervisory Control and Data Acquisition Systems (SCADA)
- All kind of field instruments likes temperature transmitters, pressure transmitters, etc.
- Control Panel Validation
- Automation/Controls Systems Validation for temperature, humidity & access control, etc.
- Laboratory Information Management Systems (LIMS)
- Building Management Systems (BMS)
- Bar code, material handling, vision inspection, and process monitoring systems
Our Computer Software Validation group provides CSV expertise and support for our clients. This dedicated group can provide specialized expertise in system implementation and validation ranging from localized control systems (e.g., PLC) to corporate wide enterprise business systems (e.g., mySAP).
Our Computer Software Validation group provides system design and implementation services in addition to traditional validation services. We strive to reduce the CSV cost by integrating our people into the design phase of the project. Our belief is that decisions made during the design phase of a project can impact the validation cost. Specific technology experience includes:
- DeltaV
- Wonderware
- iFix
- Rockwell
- mySAP
- PeopleSoft
- Oracle
- POMS
- Documentum
- ASi
- Profibus
- Devicenet
- Foundation Fieldbus
|
