Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

SAP Software Testing, Verification and Validation

1. Product Description

The leading commercial enterprise business software now has a pre-packaged validation solution for the life sciences, medical device and pharmaceutical industries. If you are newly implementing or planning an upgrade to SAP, verification and validation suite is now available as a fixed-price, pre-written packaged solution.

Compliant SAP Pre-packaged Verification and Validation Suite

The pre-packaged SAP software testing, verification and validation solution is based on extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device, and biotechnology companies. SAP compliance validation product allows you to meet your obligations of regulatory bodies like FDA, EU Regulatory Authority, Notified Bodies, Competent Authorities etc.

Ready off the shelf SAP verification and validation suite offers alternative to manual, labor-intensive validation efforts. The ready off the shelf package includes

  • Regulatory Requirements
  • Regulatory Verification and Validation Strategy
  • Regulatory Plan template
  • Quality Plan template
  • Verification and Validation Plan template
  • Traceability Matrix Template
  • Installation Qualification (IQ) Protocols
  • Operational Qualification (OQ) Protocols
  • Performance Qualification (PQ) Protocols
  • Validation Summary Report template

Industry tested pre-packaged SharePoint Validation solution allows certified validation compliance in shorter time frame and considerable savings.

Pre-packaged Procedures

The pre-packaged procedures are:

  1. System Security
  2. Backup and Restore
  3. Record Retention
  4. New Release Evaluation
  5. Item Master Update
  6. Change Control

Pre-packaged Training

The pre-packaged training templates will be customized to your application needs and at your request we will also train users.

Regulatory Agency Approval

Properly validated solutions are more likely to avoid regulatory scrutiny in the form of regulatory observations, citations or violations. These time consuming and disruptive events can pose a real business risk as it relates to agency approval of new product introductions and sales of existing products.

Antrix ensures that your automation software is compliant to elements of regulations pertaining to your industry. For medical device we ensure that you are compliant to FDA Title 21 CFR Part 801, 803, 812, 814, 820, 822 and ISO 13485 regulations. In case of drugs adherence to  FDA Title 21 CFR Part 210, 211, 312, 314. For biologics compliance to FDA Title 21 CFR Part 600, 606, 610, ICHQ7, ICHQ9, ICHQ10 etc.

The SharePoint pre-packaged verification and validation suite ensures compliance to some of the regulatory requirements as listed below:

FDA Title 21 CFR Part 820.70 Production and Process Controls - (i)Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

ISO 13485 - Medical Devices - Quality management systems - Requirements for regulatory purposes Section 7.5.2 - Validation of process for production and service provisions. The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software application shall be validated prior to initial use. Records of validation shall be maintained.

FDA Title 21 CFR Part 11 - Electronics Signature and Electronic Records

Title 21 CFR Part 11 final rule provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology.

ISO 14971:2007 - Medical Devices - Application of risk management

Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk

Health Insurance Portability and Accountability Act - HIPAA

Law to Prevent abuse, fraud and waste of health insurance, health delivery, and other aspects of health including acceptable method of transport of these files electronically.

ISO 27001 Information Security

The “ISO27k” (ISO/IEC 27000-series) standards provide good practice guidance on designing, implementing and auditing Information Security Management Systems to protect the confidentiality, integrity and availability of  the information on which we all depend.


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our customized product based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 90 % > 90 % > 90 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our product. Company size is based on annual sales as per FDA classification.


3. Price

$ sales@antrix.com or call