GDPR Compliance Statement
The EU General Data Protection Regulation (“GDPR”) becomes effective 25th of May 2018 in the European Union bringing significant changes to data protection law.
This Regulation intends to standardize data protection laws and afford individuals stronger rights to access and control of their personal information in a more consistent manner.
ValGenesis provides quality software products and services securely to our life sciences customers, minimizing risks and interruptions. ValGenesis continually improves its process through risk assessments by implementing new security controls that would meet the regulatory and customer requirements in the life sciences domain.
ValGenesis is committed to ensuring the security and protection of all information we process, and to provide a compliant and consistent approach to data protection. ValGenesis provides a software system with associated infrastructure for its customers to process their own data. ValGenesis does not control or process any personally identifiable data on our customer’s behalf. We have always had a robust and effective data protection program in place which complies with existing law and abides by data protection principles. However, we recognize our obligation to ensure our process meets all GDPR requirements that expressly apply.
ValGenesis is dedicated to safeguarding the personal information under our remit and in developing a data protection regime that is effective, fit for purpose and demonstrates an understanding of, and appreciation for the new Regulation. Our preparation and objectives for GDPR compliance have been summarized in this statement and include data protection roles, policies, procedures, controls and measures to ensure maximum and ongoing compliance with all regulatory requirements including GDPR.
How We are Preparing for the GDPR
ValGenesis already has a consistent level of data protection and security across our organization, however it is our aim to be fully compliant with the GDPR. Our preparation and plan include:
- Information Audit – carrying out a company-wide information audit to identify and assess what personal information we hold, where it comes from, how and why it is processed and if and to whom it is disclosed.
- Policies & Procedures – assessing existing data protection policies and procedures to meet the requirements and standards of the GDPR and any relevant data protection laws, including: –
- Data Protection – our policy and procedure documents related to data protection are being assessed and will be revised if necessary to meet any new applicable standards and requirements of the GDPR. Accountability and governance measures are in place to ensure that we understand and adequately disseminate and evidence our obligations and responsibilities; with a dedicated focus on privacy and the rights of individuals.
- Data Retention & Erasure – we are assessing and will update our retention policy and schedule if deemed necessary to ensure that we meet the ‘data minimization’ and ‘storage limitation’ principles and that personal information is stored, archived and destroyed compliantly and ethically. Dedicated erasure procedures will be made effective to meet the new ‘Right to Erasure’ obligation and are aware of when this and other data subject’s rights apply; along with any exemptions, response timeframes and notification responsibilities.
- Data Breaches – our breach procedure ensure that we have safeguards and measures in place to identify, assess, investigate and report any personal data breach at the earliest possible time. Our procedures are robust and have been disseminated to all employees, making them aware of the reporting lines and steps to follow.
- International Data Transfers & Third-Party Disclosures – International Data Transfers & Third-Party Disclosures – robust procedures and safeguarding measures are in place to secure, encrypt and maintain the integrity of the data. Procedures will include a continual review of standard data protection clauses or approved codes of conduct, as well as provisions for binding corporate rules. Strict due diligence checks will be performed to assess and verify that appropriate safeguards are in place to protect all information, ensure enforceable data subject rights and have effective legal remedies for data subjects where applicable.
- Subject Access Request (SAR) – ValGenesis will determine if Subject Access Request procedures are to be implemented. If it is determined to be required, then ValGenesis will implement SAR procedures to accommodate the revised 30-day timeframe for providing the requested information and for making this provision free of charge. If required, new procedures will detail how to verify the data subject, what steps to take for processing an access request, what exemptions apply and a suite of response templates to ensure that communications with data subjects are compliant, consistent and adequate.
- Legal Basis for Processing – we are reviewing all processing activities to identify the legal basis for processing and ensuring that each basis is appropriate for the activity it relates to. Where applicable, we also maintain records of our processing activities, ensuring that our obligations under Article 30 of the GDPR and Schedule 1 of the Data Protection Bill are met.
- Privacy Notice/Policy – we are revising our Privacy Notice(s) to comply with the GDPR, ensuring that all individuals whose personal information we process have been informed of why we need it, how it is used, what their rights are, who the information is disclosed to and what safeguarding measures are in place to protect their information.
- Obtaining Consent – we are revising our consent mechanisms for obtaining personal data, ensuring that individuals understand what they are providing, why and how we use it and giving clear, defined ways to consent to us processing their information. We have developed stringent processes for recording consent, making sure that we can evidence an affirmative opt-in, along with time and date records; and an easy to see and access way to withdraw consent at any time.
- Direct Marketing – we are revising the wording and processes for direct marketing, including clear opt-in mechanisms for marketing subscriptions; a clear notice and method for opting out and providing unsubscribe features on all subsequent marketing materials.
- Data Protection Impact Assessments (DPIA) – where we process personal information that is considered high risk, involves large scale processing or includes special category/criminal conviction data; we are developing stringent procedures and assessment templates for carrying out impact assessments that comply fully with the GDPR’s Article 35 requirements. We are implementing documentation processes that record each assessment, allow us to rate the risk posed by the processing activity and implement mitigating measures to reduce the risk posed to the data subject(s).
- Processor Agreements – where we use any third-party to process personal information on our behalf (e. Payroll, Recruitment, Hosting, etc.), we are drafting compliant Processor Agreements and due diligence procedures for ensuring that they (as well as we), meet and understand their/our GDPR obligations. These measures include initial and ongoing reviews of the service provided, the necessity of the processing activity, the technical and organizational measures in place and compliance with the GDPR.
- Special Categories Data – where we obtain and process any special category information, we do so in complete compliance with the Article 9 requirements and have high-level encryptions and protections on all such data. Special category data is only processed where necessary and is only processed where we have first identified the appropriate Article 9(2) basis or the Data Protection Bill Schedule 1 condition. Where we rely on consent for processing, this is explicit and is verified by a signature, with the right to modify or remove consent being clearly signposted.
Data Subject Rights
In addition to the policies and procedures mentioned above that ensure individuals can enforce their data protection rights, we provide easy to access information via our website of an individual’s right to access any personal information that ValGenesis processes about them and to request information about: –
- What personal data we hold about them
- The purposes of the processing
- The categories of personal data concerned
- The recipients to whom the personal data has/will be disclosed
- How long we intend to store your personal data for
- If we did not collect the data directly from them, information about the source.
- The right to have incomplete or inaccurate data about them corrected or completed and the process for requesting this.
- The right to request erasure of personal data (where applicable) or to restrict processing in accordance with data protection laws, as well as to object to any direct marketing from us and to be informed about any automated decision-making that we use.
- The right to lodge a complaint or seek judicial remedy and who to contact in such instances
Information Security Management & Technical and Organizational Measures
ValGenesis takes the privacy and security of individuals and their personal information very seriously and take every reasonable measure and precaution to protect and secure data we process. We have robust information security policies and procedures in place to protect personal information from unauthorized access, alteration, disclosure or destruction and have several layers of security measures, including:
- E-Mail policy
- Clear desk and clear screen policy
- Password policy
- Desktop and acceptable user’s policy
- Blogging, social media and networking policy
- Access Control, Data Privacy, Data Integrity policy and Secured development
- Mobile and Teleworking policy
- Cloud policy
- Backup policy
- Administrative Operational policy
- Validation Master Plan
- Classification of Information
- Risk Management
- Information security objectives and planning to achieve them
- Documented information
- Operations activities
- Security committee meeting
- Business Continuity Plan
- Risk assessments
- IS operations & support review and performance reporting
- Performance evaluation
- Monitoring, measurement, analysis and evaluation
- Internal audit
- Management review
- Nonconformity and corrective action
- Continual improvement
GDPR Roles and Employees
ValGenesis Data Protection Officer and data privacy team are working to develop and implement our roadmap for complying with the new data protection Regulation. The team are responsible for promoting awareness of the GDPR across the organization, assessing our GDPR readiness, identifying any gap areas and implementing the new policies, procedures and measures.
ValGenesis understands that continuous employee awareness and understanding is essential for GDPR compliance. GDPR is now included in ValGenesis’ formal training program and all employees are required to complete the GDPR training.
If you have any questions about our preparation for the GDPR, please contact our Data Protection Officer (DPO) via email to firstname.lastname@example.org. Alternatively, visit our website www.valgenesis.com or direct link to contact information at https://www.valgenesis.com/contact-us/.