Any pharmaceutical, biotechnology, genomics, chemical, medical device, and supply chain management company finds challenging to answer the compliance. These organizations must comply with stringent quality, safety, and compliance requirements in each geography where their products are distributed. The current Regulatory compliance management trend is moving towards global harmonization of quality and safety. Whether you are a manufacturer or a supplier, your market expansion, continual improvement, and customer satisfaction rests principally on the quality standards of your business.

Professional Ora’s Regulatory Compliance, Audit and Validation can help in this effort by assisting you with professionally-aided Compliance, Audit and Validation Services for Pharmaceuticals, Medical Devices, Consumer, and healthcare industries such as cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practice), GDP (Good Distribution Practice), Good Laboratory Practice (GLP), GPVP (Good Pharmacovigilance Practice), and GxP Computer System Validation (CSV).

Professional Ora provides Regulatory Compliance, Audit, and Validation Services that involve evaluating your requirements and suggesting inputs to business processes designed to assure customer satisfaction. With our compliance audit report preparation and readiness strategies, we provide compliance and audit (gap analysis) reports, including suggested Corrective and Preventive Actions (CAPA) to avoid potential 483s and audit findings from regulators.

We provide Regulatory compliance and validation services to ensure that all your processes and products are aligned with the applicable quality, information security, and Regulatory compliance audit requirements such as (but need not be limited to) the following:

SOP Development – Overview

The Life Sciences industry is moving towards procedural standardization, risk-based methodology, Quality by Design and a common control framework. However, Standard Operating Procedures (SOP) review and SOP writing services may sometimes require organizations to invest time and money to research global legislation and update the systems perennially. In such scenarios, organizations look for expert SOP writing services and SOP review services.

Professional Ora provides SOP authoring services for all types of pharmaceutical practices, research and development, Annual Product Quality Review (APQR), information technology, Regulatory Affairs, quality management review, clinical research, and all categories of pharmaceutical SOPs.

  GxP Audit Services – Overview

In pharma/biotech/cosmetics/medical devices industries, quality can be defined by strong GxPs intended to be implemented and followed throughout the lifecycle. Pharmaceutical organizations find vendor evaluation (verifying compliance of multiple vendors to select the best vendor) and vendor audit (verifying compliance levels of existing vendors as part of a continual improvement process) challenging.

To implement vendor evaluation and vendor GxP audit process, time-critical and ever-evolving GxP compliance requirements of manufacturing (GMP), distribution (GDP), clinical trials (GCP), laboratory (GLP (BA-BE, Clinical)), and process automation (GAMP) must be adhered to. In such scenarios, Professional Ora can meticulously work with clients in vendor GxP audit evaluation and vendor auditing processes.

As part of vendor evaluation, Professional Ora can provide GxP compliance consulting and verify the compliance levels of multiple vendors to submit the GxP audit reports to the clients. Subsequently, clients can decide on the selection of vendors upon Professional Ora’s advice.

Computer System Validation and Computer Software Assurance – Overview

There are many questions in your brain whether used software product is at par with the global Regulatory requirements? Has it been evaluated for successful functioning? How many quality barriers did it come through for a final compliant version? Did it complete all the stages of the software development lifecycle? If you are puzzled by these queries, validation should be the answer.

Whenever software or a system is built or planned for development, Computer Software Assurance (CSA) is an integral part to be considered. Organizations should validate their products per the regulations such as 21 CFR Part 11 Software Validation, 21 CFR 820 Software Validation, and GAMP 5 Computer System Validation. Right from building software to reaching compliant versions, organizations may face difficulties in completing the entire validation lifecycle.

As the industry is moving away from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA), Professional Ora can prepare you for a seamless transition. With an in-house compliance team, we support organizations to perform software verification and validation, Computer System Validation (CSV), pharma Computer Software Assurance (CSA), pharma CSV, and periodical process and product validation. Our team establishes documental evidence throughout the lifecycle. From large projects to mid-size and temporary requirements, we work with clients from concept to developing software, to ensure the clients’ products meet necessary Regulatory requirements.

Computer System Validation (CSV)

Validation is an integral part of the pharma industry and must be done for every software that an organization uses. It is required to assess if the software complies with cGMP requirements. With technological advancement in the industry and more online and virtual processes in play, the potential risk of non-compliance is on the rise. In such scenarios, keeping track of periodical software updates might be challenging for manufacturers.

Professional Ora has expertise in performing progressive Computer System Validation (CSV) per the US FDA, EU, PIC/s, GAMP 5, ICH, WHO, 21 CFR Part 11, and EU Annex 11 requirements. Our CSV validation experts are experienced in handling simple to complex projects in modified Waterfall or Sprint methodologies. The quality gate review framework minimizes re-work in the product validation & vendor validation processes, and ensures total compliance at any stage during deployment, maintenance, and decommissioning.

Progressive Computer Software Assurance (CSA) and validation per health authority guidelines
Computer Software Assurance (CSA) and validation process/software process validation
Software validation verification
Compliance software solutions
Software Regulatory compliance
Process validation in pharma
GMP software validation
Process validation in manufacturing of biopharmaceuticals
Vendor audit services
Computer System Validation (CSV) in the pharmaceutical industry
Accurate methodologies
Validation throughout the lifecycle
Pre-designated quality gates to minimize reworks
Validation certificate
Data security and compliance

Retro Validation

Legacy systems without proper validation are always a burden to an organization at the time of audit. Lack of proper documentation or workflows cannot withstand a Regulatory or customer audit. During such times, the best fit for your organization is to opt for an expert GAMP 5 software validation partner to retrospect the systems that are already defined and implemented.

Professional Ora’s experienced compliance and validation team performs retrospective validation and makes your existing system compliant with GAMP 5 computer system validation and ready to face any audit. We also analyze existing documentation and suggest required technicalities to fill the gaps in the documentation. Our team performs disaster risk assessment, medical software verification, and software audits.

Our validation services encompass the following activities:

Retrospective validation for existing systems
Analyzing gaps in existing documentation
Expert validation support to fill the gaps
Validation certificate

QMS Remediation & Establishment – Overview

Our Quality Management Systems (QMS) remediation & establishment services are tailored to meet the stringent compliance requirements of the Life Sciences industry. With a focus on creating robust QMS, we ensure that your organization adheres to global Regulatory standards, minimizes risks, and enhances operational efficiency. Our comprehensive approach covers everything from initial gap assessments to full-scale implementation and continuous improvement of your QMS.

       QMS Remediation & Establishment

Comprehensive gap analysis: Identifying deficiencies in your current QMS and developing a strategic remediation plan.
Customized QMS development: Designing a QMS tailored to your organization’s specific needs, ensuring compliance with global regulations.
Documentation and training: Creating essential QMS documentation and providing training to ensure seamless adoption across your organization.
Process mapping: Analyzing existing processes and designing efficient workflows that enhance quality and compliance.
Standard Operating Procedures (SOPs): Developing and standardizing SOPs to ensure consistency and reliability in your operations.
Risk management: Integrating risk-management principles into process design to proactively identify and mitigate potential issues.
Technology integration: Leveraging advanced technologies to streamline processes and enhance data integrity.