Compliance


Compliance is a statutory pharma requirement. CaliberLIMS is a web-based solution that helps pharma companies meet their compliance needs easily. It completely adheres to the 21 CFR Part 11 guidelines laid by US FDA. It is also compliant with cGMP, ALCOA Plus, MHRA, and other regulatory authorities laid guidelines.

1. Data Integrity

CaliberLIMS generates complete copies of records in human-readable format apart from electronic form. The records are available in “Read-Only” option to ensure data integrity. But, only some users can edit certain set of data whenever required to make necessary authentic changes.

 

2. Easy and Controlled Access

With CaliberLIMS, pharma companies can have easy and controlled access to their electronic records. Only privileged users can retrieve the records from the system. Thus, it ensures complete security of the data.

 

3. Limited Access to Authorized Personnel

The application allows only authorized personnel with relevant ID and password credentials to access the data. Further, access to certain set of records can be provided to only a set of authorized individuals to ensure there is no misuse of data.

 

4. Audit Trail

All the documents created have audit trail. CaliberLIMS ensures to save the date of record creation and modification details. It also provides the details of the person who carried out the change and the exact changes. As no records can be deleted from the system, the history of the documents is maintained if required for the audit process. Otherwise, the obsolete records can be made inactive based on the approvals.

 

5. Unique Electronic Signature

The system ensures that no two users have the same user ID. It, thus, facilitates a unique electronic signature for every electronic record.