Product
Ingenium has a long experience with 21 CFR compliance for systems used in packaging like Labelling machines, Overwrapping machines, Vertical FFS machines already installed and commissioned in various leading Pharma manufacturers in India.
Ingenium specializes in interfacing its systems with Track and Trace solutions from reputed companies and collaborating to run various Tamper Evident machines for cartons.
Ingenium is a leading provider of automation solutions for the pharmaceutical industry. Ingenium’s solutions are designed to meet the unique needs of pharmaceutical companies, including compliance with regulations such as 21 CFR Part 11.
Ingenium's solutions include electronic batch records (EBRs), which are designed to meet the requirements of 21 CFR Part 11. EBRs provide a secure and reliable way to record and manage batch information, including batch numbers, dates, and production details. EBRs are designed to be compliant with regulations governing data integrity, security, and authenticity.
Ingenium's solutions include electronic signatures, which are compliant with 21 CFR Part 11. Electronic signatures provide a secure and reliable way to sign and approve documents, including batch records and other critical documentation. Ingenium's electronic signatures are designed to be compliant with regulations governing identity verification, authorization, and audit trails.
Ingenium's solutions include audit trails, which are designed to meet the requirements of 21 CFR Part 11. Audit trails provide a detailed record of all activities related to a batch, including who performed the activity, when it was performed, and what changes were made. Ingenium's audit trails are designed to be compliant with regulations governing data integrity, security, and authenticity..
Ingenium's solutions include data integrity features, which are designed to ensure that data is accurate, complete, and reliable. Ingenium's solutions are designed to prevent data loss, corruption, or unauthorized changes, and to ensure that data is only accessible to authorized personnel.
Ingenium's solutions include validation and documentation features, which are designed to ensure compliance with 21 CFR Part 11. Ingenium's solutions are designed to be validated to ensure that they meet the requirements of the regulations, and to provide clear documentation of the validation process.
The FDA requires businesses to maintain all documents electronically. Businesses using a closed system to maintain records must comply with 21 CFR Part 11.10.
Businesses using the closed system must employ procedures and controls designed to maintain electronic records’ authenticity, integrity, and confidentiality.
Ingenium Electronics Private Limited.
1st Floor, Plot No. 13, S. No. 18, Lane No. 4 ,
Ramtekdi Industrial Area, Hadapsar,
Pune – 411013, Maharashtra, India
