Q: Where can you provide these services?
A: We are an international company with resources around the globe. We are prepared to support your company wherever your business takes you.
Q: What kind of pharmaceutical companies do you assist?
A: The focus of the companies we help covers a wide range of products. Our clients include manufacturers of injectable pharmaceuticals, oral solid dosage, medical devices, diagnostics, cosmetics, personal care products, and more.
Q: Do you supply qualification, calibration, and commissioning equipment or can you use the sensors we keep in house?
A: The choice is yours. We have a variety of reference standards and validation equipment within calibration using NIST-traceable standards that is maintained within our ISO 9001:2008 certified calibration laboratory. Our consultants have experience using many types of qualification and metrology equipment, so they can also use the equipment you have available to complete your project.
Q: How does implementation work?
A: You get to choose the way implementation works. Typically, implementation takes place in 3 ways:
- Pre-configured workflows are provided and used out of box with no additional work required.
- Pre-configured workflows are provided and modified by your System Administrator.
- PSC Software’s internal implementation team can manage your implementation from start to finish.
Q: Is your software compliant?
A: Our software is FDA (21 CFR Part 11), GDPR and HIPPA compliant, so you only have to worry about doing your job, nothing extra.
Q: Is my company too small for your software?
A: No company is too large or small to use ACE or Audit Utopia. Our software is built to be a right-sized solution for startups and multi-national companies.
Q: What kind of support will my company receive post software implementation?
A: Your annual license includes Tier I technical support. Additional levels of technical support are available at an additional cost.
Q: Are there any additional costs aside from the initialization fee and user licensing upkeep fees?
A: No, we do not charge for anything else. The only other cost besides the Initialization Fee and License Fee is if you would like PSC Software’s internal implementation team manage the implementation of the software (applies to ACE only).
Q: What is Computer Systems Validation (CSV)?
A: Computer System Validation is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. In order to be compliant with the FDA 21 CFR 11, the validation of computerized systems is required. There are 3 components to CSV, Install Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
Q: What do you mean by single platform?
A: Simply put, ACE can function as your single platform for every quality, controlled document, learning, supplier and more in a single validated platform.