Incantare is a boutique consultancy company and we provide IT services to regulated industries including Pharmaceuticals, Chemical, Oil and Gas industries.
Our consultants specialized in System Testing planning, execution, and project management; and Computer System Validations as elaborated below.
System Testing planning, execution, and project management services
Our consultants have expertise skills with specialized software tools, like HP Application LifeCycle Management (ALM)* to support manual and automated testing with electronic records that would be FDA CFR Part 11 compliant.
We are also experienced with large scale testing and project management of large-scale testing projects.
IT QA / Computer System Validations services
Our consultants support our clients’ key systems in accordance with clients’ Quality Management Systems. Our consultants are considered Subject Matter Experts on the GAMP5* and ISA-95* standards.
We are experienced with delivering critical documents like Quality Plan, Data Integrity Assessment, Design Specifications, Installation & Operational Qualification, Test Scripts authoring, Performance Qualification and Validation Summary Report across different systems and platforms.
* – All the software and standard names mentioned above are registered trademarks of the respective companies and organizations.