Software Validation
/ By Panorama Consulting & Engineering Inc. / Audits and Process Improvements/ 0 Comments

Software Validation

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity.
Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.

Software Validation commences with a user requirement document (URS). URS is prepared to describe the critical functionalities those are required for our analysis. It is essential that the document is properly scoped in order that the procurement, installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.

To scope and define an adequate validation procedure the URS has to be detailed sufficiently for various assessments to be made. The main assessment that concerns with qualification documentation is the risk assessment. This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.

So at this early stage it is required to execute a Validation Risk Assessment protocol against the end user’s requirements. This step is purely to ensure that the more obscure pieces of ancillary equipment and support services are fully understood and their requirement investigated, priced and included in the final issue of the URS; which will be sent out with the Request to Tender. This is an essential stage if the URS is to accurately define what depth and scope of validation is appropriate for the verification that the software will deliver all the requirement detailed in the URS.

The outcome of the Validation Risk Assessment (VRA) drives a split in software validation documentation scope, if the VRA categorizes the software validation as requiring Full Life Cycle Validation (FLCV); then a considerable amount of the software validation effort is put into establishing how the software originated, was designed and developed, in order to establish that its basic concept and development can be considered robust, sound and in accordance with best practices.

The original development plans; code reviews, methods reviews and testing plans must be available to enable this software validation documentation to be executed successfully. Once this proof of quality build is established, validation then follows a more convention path in inspections and verifications.

Software that is not classified as requiring FLCV treatment does not require this depth of verification into quality build history and is validated mainly by the more convention path in inspections and verifications.

Dynamic Testing

Dynamic testing verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software. Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods. One such method is static analysis. This somewhat new method largely automates the software qualification process. The technique attempts to identify errors in the code, but does not necessarily prove their absence. Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the FDA and some segments of industry recognize the value of sound verification principles and are using tools based on these principles.

/ By Panorama Consulting & Engineering Inc. / Pharmaceutical Industry • Safety • System design • Utility Optimization/ 0 Comments

Utility Systems Qualification – Backbone for the Pharmaceutical Industry

Pharmaceutical manufacturing is a highly regulated industry. Given the stress on product quality and the widespread impact of substandard production on public health and safety, utility system qualification is a critical step that companies must take towards ensuring that all their products comply with federal laws and regulations.

In pharmaceuticals, critical utilities like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support the manufacturing process. As a result, these are treated as products that need to satisfy FDA regulatory requirements and pharmaceutical manufacturing standards, just like raw materials and other equipment used in the industry.

Quantitative and qualitative specifications: Utilities must pass a string of qualitative and quantitative specifications to be considered satisfactory. Different utility systems have different quality and standard criteria, designed on the basis of inputs from relevant departments and organizations as well as manufacturing and engineering provisions. When a validation program is set in place for utility systems used in pharmaceutical, critical utilities should be first on the list. It’s important to focus on the design, qualification and monitoring of each utility system used in pharmaceutical or biotech companies, so their end product fulfills all pharmaceutical quality standards.

cGMP and FDA guidelines: Utility system qualification is designed to ensure that utilities in use conform to health and safety regulations, as well as pharmaceutical manufacturing standards and cGMP guidelines. Current good manufacturing practices (cGMPs) are FDA guidelines that check the design, control and monitoring of manufacturing facilities and processes. To comply with cGMP regulations, drugs and medicinal products need to be of the right quality, strength and purity, by way of adequately controlled and monitored manufacturing operations.

Steps in utility system qualification include:

  • Implementing strong operating procedures
  • Establishing extensive quality control systems
  • Procuring a consistent quality of raw material supplies
  • Maintaining dependable testing labs

If such a broad control system is implemented in a pharmaceutical facility, it can help to control:

  • Instances of mix-ups
  • Contamination, errors
  • Defects and deviations during the manufacturing process

Such pharmaceutical products are better able to meet public health and safety laws established by the FDA.

Flexibility: Pharmaceutical cGMP guidelines are flexible enough that all manufacturers are free to decide how to apply FDA controls in ways that fit their unique requirements. They can make use of a variety of processing methods, testing procedures and scientific designs to adapt their manufacturing processes to meet the laws. Because of the flexibility of these laws, companies can use innovative approaches and sophisticated technology to implement a system of continual improvement in order to achieve a consistent quality of pharmaceutical supplies.

FDA approved regulations: All pharmaceutical manufacturing facilities need to adhere strictly to FDA-approved regulations. Failure to meet FDA regulations can result in responsive action by the authorities against the product or the responsible facility, depending upon the seriousness of non-compliance. The company may have to recall the product under orders of the FDA, to ensure it does not cause additional harm or risk to the public.

cGMP requirements can be useful in ensuring the efficacy, quality and safety of pharmaceutical products by making sure facilities are in good operating condition, with sufficiently calibrated and well-maintained equipment, trained and experienced staff and reliable and efficient processes.

While a utility system cannot affect product quality on its own, it forms an integral part of the manufacturing process. That is where Panorama Consulting and Engineering, Inc. helps the companies setting up the validation processes as per the regulatory requirements.