Facilitate GMP Compliance

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GMP Compliant Digital Solution

Review by Exception

OpsTrakker enforces correct data entry, captures deviations with comments, and maintains the entire, proper, audit trail to achieve higher compliance levels

OpsTrakker’s electronic solutions facilitate compliant manufacturing operations for Pharmaceutical Manufacturing and the Life Sciences Spaces. Leveraging decades of experience implementing and validating digital systems, OpsTrakker facilitates compliance in a number of ways to ensure compliant operations with GMP regulations.  

Both GMP and 21 CFR Part 11 compliant, OpsTrakker delivers off-the-shelf compliance functionality, to meet regulatory and organizational requirements: 

  • Off-the-Shelf Review by Exception
  • In-House OpsTrakker Validation Support for Rapid Deployment
  • Parameterization to maximize efficient form use and activity management
  • Delivery of full vendor qualification package
  • Complete Audit Trail for all internal and external transactions
  • Activity guidance upon form or workflow execution
  • And More...

Available for iOS, Android, and supported browsers, advance your digitalization strategy with OpsTrakker. 

Right First Time Execution

Through parameterization and input data entry validation, OpsTrakker is the perfect solution to help your shop-floor achieve Right-First-Time, every time. OpsTrakker enforces pre-configured entry limits to enable intelligent data capture during execution. Entries are safeguarded against errors and risks,  common to paper or paper-on-glass alternatives. Such errors and risks include: 

  • Incorrect Handwritten Entry
  • Illegible Handwriting
  • Hand Calculation Errors
  • Complex data storage and recordkeeping systems
  • Damage to records and physical documents

During form authoring/designing, the form author may configure upper/lower limits or valid/invalid values. Limits are enforced at run-time for both operator or system entered values.  The author can also specify the course of action to be taken in the event an input validation failure. 

OpsTrakker triggers an exception message in the event the entry/input is invalid. Thus, operations can instantly identify data entry errors and address them at the source, in real-time. OpsTrakker’s form execution history gives on overview of all for comments and exceptions to provide instant visibility, while helping to avoid costly downstream discrepancies. 

Failure to meet GMP requirements could result in significant fines or production losses. Meanwhile, paper based systems fail to capture data for deeper production insight.

 

Review by Exception

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