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Validation Service Overview

AnumTech Systems provide full range of Validation and Compliance services to Life Science, pharma and biotech industry. We can assist you in evaluating, optimizing and ensuring the compliance of your systems, software, process, equipment and utilities respecting regulatory requirements: GxP FDA,GAMP, EMEA and similar international regulations. We are specialized in 21 CFR Part 11 compliance  

Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologic; our Validation services and resources can navigate their way through the regulations and help you set up a compliant but practical validation approach. 

Whether it’s the need for computer system validation as part of a vital process automation project, the generation of a robust suite of operating procedures, assistance with the latest 21 CFR Part 11 requirements or an audit of your existing systems and validation status, there is an ATI service to benefit your organization.

Our Area Of Expertise:

  • Computer System Validation
  • IT Infrastructure Qualification
  • Equipment Validaiton
  • Facility & Utility Commissioning and Qualification
  • Process Validation

Computer System Validation

We have extensive experience validating various computer systems against FDA Part 11 and Annex 11 requirements

 All Computer Systems and software that perform regulated functions or processes must be identified and validated to regulatory specifications. 

Whether your system is a small instrument control system or a global tracking or ERP system, ATI has the resources to lead and execute your project.

If you are considering a new computer system we can review it against the predicate rules to ensure it is compliant before you start implementation (or before you sign any contracts!).

If you have an existing system and you aren’t sure if it needs to be compliant or if it even can be made to be, we’ll review it and recommend any remediation required to comply with 21 CFR Part 11 or Annex 11 requirements.

Validation Training

An integral part of compliance with cGxPs is the acquisition / retention of personnel with sufficient education, experience and training to do the job properly. This requirement is explicitly stated in Part 211 of Title 21. ATI  is experienced in providing training and/or review classes for cGxP and validation programs for systems, equipment, and computerized processes. All training is thoroughly documented. ATI can also assist in the establishment of an on-going training program

Data Migration Validation

At AnumTech System, We provide unparalleled ‘Independent Data Migration Validation service to provide 100% purity and completeness of your data migration. Our approach for Data Migration will ensuring proper extraction from source system, ensuring proper data transformation into flat files (CSV, XML etc.), ensuring proper load into target system

21 CFR Part 11 & Annex 11 Assessment

AnumTech System provides Part 11 & Annex assessment services that are designed to help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures, and that those functions are in conformance with the FDA requirements of 21 CFR Part 11. 

GAP Analysis & Auditing

ATI can provide independent assessments and/or audits which can cover the entire system, equipment or computerized processes or target a specific area. These audits serve not only to enumerate quality assurance and design weakness, but also to offer corrective action. The results of the audit are summarized and the priority actions to allow its use as a management tool. An implementation plan and schedule can also be established to maximize its effectiveness and minimize client company exposure to regulatory authorities. ATI keeps current with the ever-changing validation climate by attending conferences and seminars, associating with regulatory agencies and reviewing the latest literature, books, and journal articles.

Standard Operating Procedures

ATI can provide independent assessments and/or audits which can cover the entire system, equipment or computerized processes or target a specific area. These audits serve not only to enumerate quality assurance and design weakness, but also to offer corrective action. The results of the audit are summarized and the priority actions to allow its use as a management tool. An implementation plan and schedule can also be established to maximize its effectiveness and minimize client company exposure to regulatory authorities. ATI keeps current with the ever-changing validation climate by attending conferences and seminars, associating with regulatory agencies and reviewing the latest literature, books, and journal articles.

Retrospective Evaluation

Ensure that valuable information is not lost for systems that were in production before your validation program was begun. We evaluate and organize existing software development life cycle (SDLC) documentation, and if necessary, reverse engineer missing documents. Many of these systems have more documentation than is realized, but because it may reside in employees’ desks, or is not organized according to current standards, it may be overlooked. In one case, we were able to save volumes of important test documentation that was mistakenly earmarked for the company shredder.

Final Validation Reports

AnumTech System has considerable experience preparing validation reports for each protocol executed. The validation reports evolve from the working validation protocols which have been structured intentionally to serve this function. At the end of the validation activity, we can prepare Final Validation Report along with the Traceability Matrix demonstrating the validation tests, validation results, deviation encountered and the requirements addressed during the validation activity..

Protocol Design and Execution

ATI has extensive experience both in design and in the execution of validation activities in the field. ATI can provide validation crews to assist the entire validation effort including both lead and support personnel in the preparation or execution of the validation on-site. The establishment of equipment history files or turnover packages plays a central role in the timely and orderly execution of validation activities. These records are instrumental in providing the validation team with the documentation required to complete the validation protocols and certify systems, equipment, and computerized processes. 

GxP Documents & Templates

With our robust GXP and QMS ready to use templates, you can save hundreds of hours that may take to create them. Our documents are simple to understand and are in compliance with applicable regulations and industry standards. Our list of document and templates includes Quality Manual, Training Plan, Policy Statements, Standard Operating Procedures (SOP), Work Instructions, Part 11 Assessment, Master Validation Plan, User and Functional Requirement, Traceability Matrix, Validation Report, IQ/OQ/PQ Plan, Protocols & Summary Report and more.

Validation Resource Service

To enable companies to cope with validation manpower demands, ATI offers a hassle-free validation resource service.

AnumTech provides skilled and reliable validation resources, with significant knowledge and experience in pharmaceutical, bio-pharmaceutical and medical device manufacturing environments

Whatever your requirements, whether you need an engineer to complete short-term validation tasks or a long-term validation project, computer system validation experts, process validation engineers, specialists in 21 CFR Part 11 or validation consultants, ATI can provide the level of expertise to meet your requirements.  

ATI can also supply a team of validation engineers, who can work for the client and responsible to them on a day-to-day basis, will manage the completion of the validation exercise. We can provide suitable experienced engineers who can plan and manage the project work, and yet work as an integrated part of the customer’s team.

ATI’s validation resource service removes the costs of agencies, the difficulties encountered in agencies selecting the right people, and the risks involved in using small companies and self employed validation personnel

ATI has extensive experience both in design and in the execution of validation activities in the field. ATI can provide validation crews to assist the entire validation effort including both lead and support personnel in the preparation or execution of the validation on-site. The establishment of equipment history files or turnover packages plays a central role in the timely and orderly execution of validation activities. These records are instrumental in providing the validation team with the documentation required to complete the validation protocols and certify systems, equipment, and computerized processes.

Key Benefits :

Assurance

We have the technical know-how to perform tasks with responsibility. We use our knowledge, creativity and skills to the utmost and efficiently to meet the standards of the quality, applicable regulations and industry standards which help the customers to rely on us for every Validation need of theirs’

All our validation Deliverables are in compliance with applicable regulations and industry standards (Validation Plans, IQ/OQ/PQ protocols, Risk Plans, Traceability Matrices, Summaries, etc.) 

You can expect cost effectiveness, Quick turnaround time, Quality, Reliability and customer centric approach with all our services. Our services are backed by a concrete commitment to our clients, right from handshake to the project completion

Experience

Our team of skilled professionals deals with the requirements and business needs of the client. We discuss schedules and budget with our customers and focus exclusively on their business challenges by delivering supreme product quality and meeting deadlines

Our Validation and Compliance resources are senior engineers, managers and possess valuable experience in their areas of expertise

Our project results have successfully withstood Inter/Vendor and FDA audits and reviews



Prime Benefit

Cost effectiveness of the services and outstanding quality of the products. Despite a high competition in the ITmarket, we are open to price reviews without compromising on the standards.

 

Quick Turnaround time, all your queries are dealt with in short period. We provide dedicated services to individual clients to deal with their queries and to provide solutions in a quick time.

“One-Stop” shop for all your regulatory compliance and validation needs. Our onestop service releases the customer from additional product related compliance and validation costs and allows establishing a long term relationship with us.

Learn how we can assist you achieve your Validation challenges in a timely and cost effective manner